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EU In Vitro Diagnostic Medical Devices Regulation (IVDR)

Self-Assess
European Union
v2017 (effective 2022)
23 domains
43 controls

The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746) establishes a comprehensive regulatory framework for in vitro diagnostic medical devices in the European Union. It became applicable on May 26, 2022, replacing the previous IVD Directive (98/79/EC). The IVDR introduces a risk-based classification system for devices, enhanced clinical evidence requirements, improved traceability through UDI, and stricter oversight of manufacturers and notified bodies. Transitional provisions extend until 2028 for certain devices to ensure market continuity.

Verified

Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (23)

Classification

1 controls
Controls in the Classification domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Annex-VIIIClassification Rules

Clinical Evidence and Performance

4 controls
Controls in the Clinical Evidence and Performance domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 4 controls
CodeTitle
Art. 56Data Breach Notification
Art. 57Transitional Provisions
Art. 58Scientific Research Data
Art. 70Criminal Penalties for False Consent

Conformity

2 controls
Controls in the Conformity domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 2 controls
CodeTitle
IVDR-Annex-IXQMS and Technical Documentation Assessment
IVDR-Art48Conformity Assessment Procedures

Essential Requirements

1 controls
Controls in the Essential Requirements domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Annex-IGeneral Safety and Performance Requirements

Governance

1 controls
Controls in the Governance domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art15Person Responsible for Regulatory Compliance

Identification

1 controls
Controls in the Identification domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art24UDI System

Identification, Traceability and Registration

4 controls
Controls in the Identification, Traceability and Registration domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 4 controls
CodeTitle
Art. 22Authorised Representatives of Providers of High-Risk AI Systems
Art. 26Obligations of Deployers of High-Risk AI Systems
Art. 28Notifying Authorities
Art. 29Application of a Conformity Assessment Body for Notification

Introductory Provisions

3 controls
Controls in the Introductory Provisions domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 3 controls
CodeTitle
Art. 1Open Finance Implementation
Art. 2Consent Definition
Art. 4Participating Institutions

Manufacturer Duties

1 controls
Controls in the Manufacturer Duties domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art10General Manufacturer Obligations

Market Access

1 controls
Controls in the Market Access domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art5Placing on the Market

Market Placement and Economic Operators

4 controls
Controls in the Market Placement and Economic Operators domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 4 controls
CodeTitle
Art. 13Transparency and Provision of Information to Deployers
Art. 14Human Oversight
Art. 5Prohibited AI Practices
Art. 9Risk Management System

Notified Bodies and Conformity Assessment

4 controls
Controls in the Notified Bodies and Conformity Assessment domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 4 controls
CodeTitle
Art. 31Designation of Chief Privacy Officer
Art. 47Existing Legal Procedures
Art. 48Criminal Penalties
Art. 52Procedure

PMS

2 controls
Controls in the PMS domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 2 controls
CodeTitle
IVDR-Art78Post-Market Surveillance Plan
IVDR-Art80Periodic Safety Update Report

Performance Evaluation

1 controls
Controls in the Performance Evaluation domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art56Performance Evaluation

Post-Market Surveillance and Vigilance

4 controls
Controls in the Post-Market Surveillance and Vigilance domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 4 controls
CodeTitle
Art. 78Inspection Powers
Art. 82Inspection Procedure
Art. 87Administrative Fines
Art. 95Inspection Supervision

Registration

2 controls
Controls in the Registration domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 2 controls
CodeTitle
IVDR-Art27Registration of Devices
IVDR-Art31Registration of Manufacturers

Representation

1 controls
Controls in the Representation domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art11Authorised Representative

Studies

1 controls
Controls in the Studies domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art58Performance Studies

Supply Chain

1 controls
Controls in the Supply Chain domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art16Importer and Distributor Verification

Technical File

1 controls
Controls in the Technical File domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Annex-IITechnical Documentation

Transition

1 controls
Controls in the Transition domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art110Transitional Provisions

Transparency

1 controls
Controls in the Transparency domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art29Summary of Safety and Performance

Vigilance

1 controls
Controls in the Vigilance domain of EU In Vitro Diagnostic Medical Devices Regulation (IVDR) — 1 controls
CodeTitle
IVDR-Art82Vigilance Reporting

Your Compliance Coverage

If you comply with EU In Vitro Diagnostic Medical Devices Regulation (IVDR), you already cover:

Pakistan Personal Data Protection Bill 2023

26%

11 controls mapped

Compare →

Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data

26%

11 controls mapped

Compare →

GDPR

26%

11 controls mapped

Compare →

+ 631 more: UK GDPR (UK General Data Protection Regulation) (26%), Ghana Data Protection Act 2012 (Act 843) (26%)

See all 634 mapped frameworks ↓

Maps to 634 other frameworks

43 total controls
Pakistan Personal Data Protection Bill 2023
11 source controls mapped|12 target controls covered
26%
Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data
11 source controls mapped|16 target controls covered
26%
GDPR
11 source controls mapped|26 target controls covered
26%
UK GDPR (UK General Data Protection Regulation)
11 source controls mapped|9 target controls covered
26%
Ghana Data Protection Act 2012 (Act 843)
11 source controls mapped|11 target controls covered
26%
Chile Personal Data Protection Law (Law No. 21.719)
10 source controls mapped|13 target controls covered
23%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
10 source controls mapped|10 target controls covered
23%
NIS2 Directive
10 source controls mapped|21 target controls covered
23%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
10 source controls mapped|11 target controls covered
23%
Laos Law on Prevention and Combating Cybercrime (2015)
10 source controls mapped|15 target controls covered
23%
UAE Federal Data Protection Law
10 source controls mapped|10 target controls covered
23%
LGPD
10 source controls mapped|14 target controls covered
23%
DORA
10 source controls mapped|20 target controls covered
23%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
10 source controls mapped|13 target controls covered
23%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
10 source controls mapped|17 target controls covered
23%
Cayman Islands Data Protection Act 2017 (DPA)
10 source controls mapped|12 target controls covered
23%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
10 source controls mapped|17 target controls covered
23%
South Korea PIPA
10 source controls mapped|9 target controls covered
23%
Australia Consumer Data Right — Banking (CDR)
10 source controls mapped|12 target controls covered
23%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
10 source controls mapped|9 target controls covered
23%
Botswana Data Protection Act (2024)
10 source controls mapped|20 target controls covered
23%
Barbados Data Protection Act 2019
10 source controls mapped|8 target controls covered
23%
EU AI Act
10 source controls mapped|15 target controls covered
23%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
10 source controls mapped|14 target controls covered
23%
Uzbekistan Law on Personal Data (No. ZRU-547)
10 source controls mapped|14 target controls covered
23%
Serbia Law on Personal Data Protection (2018)
10 source controls mapped|12 target controls covered
23%
Oman Personal Data Protection Law (Royal Decree 6/2022)
10 source controls mapped|13 target controls covered
23%
EU Network Code on Cybersecurity for the Electricity Sector
10 source controls mapped|13 target controls covered
23%
Portugal Law No. 58/2019 — Data Protection Implementation Act
10 source controls mapped|17 target controls covered
23%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
10 source controls mapped|10 target controls covered
23%
Uruguay Personal Data Protection Act (Law No. 18.331)
10 source controls mapped|13 target controls covered
23%
Privacy Act 1988 (Australia)
9 source controls mapped|8 target controls covered
21%
NIST AI Risk Management Framework (AI RMF 1.0)
9 source controls mapped|10 target controls covered
21%
NIST AI 600-1 Generative AI Profile
9 source controls mapped|11 target controls covered
21%
APPI
9 source controls mapped|9 target controls covered
21%
Argentina PDPA
9 source controls mapped|8 target controls covered
21%
Azure Security Benchmark
9 source controls mapped|6 target controls covered
21%
Indonesia PDP Law
9 source controls mapped|9 target controls covered
21%
Maryland Online Data Privacy Act
9 source controls mapped|7 target controls covered
21%
Colorado Privacy Act
9 source controls mapped|9 target controls covered
21%
COPPA
9 source controls mapped|9 target controls covered
21%
Delaware Online Privacy and Protection Act (proposed)
9 source controls mapped|8 target controls covered
21%
Montana Consumer Data Privacy Act
9 source controls mapped|9 target controls covered
21%
Malaysia PDPA 2010
9 source controls mapped|9 target controls covered
21%
Kenya DPA
9 source controls mapped|9 target controls covered
21%
POPIA
9 source controls mapped|9 target controls covered
21%
Jamaica DPA
9 source controls mapped|8 target controls covered
21%
Oregon Consumer Privacy Act
9 source controls mapped|8 target controls covered
21%
Minnesota Consumer Data Privacy Act
9 source controls mapped|9 target controls covered
21%
New Zealand Privacy Act
9 source controls mapped|9 target controls covered
21%
Rwanda DPL
9 source controls mapped|9 target controls covered
21%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
9 source controls mapped|8 target controls covered
21%
New Hampshire Privacy Act
9 source controls mapped|9 target controls covered
21%
FERPA
9 source controls mapped|9 target controls covered
21%
ASEAN Data Management Framework
9 source controls mapped|12 target controls covered
21%
UAE PDPL
9 source controls mapped|8 target controls covered
21%
Iowa Consumer Data Protection Act
9 source controls mapped|9 target controls covered
21%
Nigeria NDPR
9 source controls mapped|9 target controls covered
21%
Ley Orgánica de Protección de Datos Personales (LOPDP)
9 source controls mapped|8 target controls covered
21%
Chile DPL
9 source controls mapped|8 target controls covered
21%
Bahrain PDPL
9 source controls mapped|9 target controls covered
21%
TEFCA — Trusted Exchange Framework and Common Agreement
9 source controls mapped|5 target controls covered
21%
Vietnam PDPD
9 source controls mapped|9 target controls covered
21%
CCPA/CPRA
9 source controls mapped|9 target controls covered
21%
Mauritius DPA
9 source controls mapped|8 target controls covered
21%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
9 source controls mapped|10 target controls covered
21%
Turkey KVKK
9 source controls mapped|8 target controls covered
21%
New Jersey Data Privacy Act
9 source controls mapped|9 target controls covered
21%
Nebraska Data Privacy Act
9 source controls mapped|9 target controls covered
21%
PDPA Singapore
9 source controls mapped|9 target controls covered
21%
Liechtenstein DPA
9 source controls mapped|9 target controls covered
21%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
9 source controls mapped|13 target controls covered
21%
Tanzania Personal Data Protection Act (Draft)
9 source controls mapped|15 target controls covered
21%
Trinidad and Tobago Data Protection Act 2011
9 source controls mapped|16 target controls covered
21%
Brunei Personal Data Protection Order 2024 (PDPO)
9 source controls mapped|13 target controls covered
21%
Utah Consumer Privacy Act
9 source controls mapped|8 target controls covered
21%
Tennessee IPA
9 source controls mapped|8 target controls covered
21%
Virginia CDPA
9 source controls mapped|9 target controls covered
21%
Iceland DPA
9 source controls mapped|9 target controls covered
21%
Taiwan PDPA
9 source controls mapped|8 target controls covered
21%
Philippines DPA
9 source controls mapped|9 target controls covered
21%
Kentucky Consumer Data Protection Act
9 source controls mapped|9 target controls covered
21%
Zimbabwe Data Protection Act (2021)
9 source controls mapped|10 target controls covered
21%
PIPEDA
9 source controls mapped|9 target controls covered
21%
China PIPL
9 source controls mapped|8 target controls covered
21%
Law No. 172-13 on the Protection of Personal Data
9 source controls mapped|9 target controls covered
21%
Norway PDPA
9 source controls mapped|8 target controls covered
21%
Digital Economy Partnership Agreement (DEPA)
9 source controls mapped|8 target controls covered
21%
Texas Data Privacy Act
9 source controls mapped|7 target controls covered
21%
Peru DPL
9 source controls mapped|9 target controls covered
21%
Mexico LFPDPPP
9 source controls mapped|8 target controls covered
21%
PDPA Thailand
9 source controls mapped|8 target controls covered
21%
UK Data Protection Act 2018
9 source controls mapped|9 target controls covered
21%
EU Digital Markets Act
9 source controls mapped|12 target controls covered
21%
EU Maritime Single Window Environment Regulation (EU) 2019/1239
9 source controls mapped|15 target controls covered
21%
Saudi Arabia PDPL
9 source controls mapped|9 target controls covered
21%
Nigeria Data Protection Act 2023 (NDPA)
9 source controls mapped|8 target controls covered
21%
India DPDP Act
9 source controls mapped|9 target controls covered
21%
CTDPA (Connecticut Data Privacy Act)
9 source controls mapped|9 target controls covered
21%
ISO 27701
9 source controls mapped|9 target controls covered
21%
Czech Republic Act on the Protection of Personal Data (Act No. 110/2019 Coll.)
9 source controls mapped|12 target controls covered
21%
Indiana Consumer Data Protection Act
9 source controls mapped|7 target controls covered
21%
Uruguay DPL
9 source controls mapped|9 target controls covered
21%
Switzerland FADP
9 source controls mapped|9 target controls covered
21%
Qatar DPL
9 source controls mapped|9 target controls covered
21%
NIST SP 800-122
9 source controls mapped|8 target controls covered
21%
ILO Nursing Personnel Convention C149 (1977)
9 source controls mapped|8 target controls covered
21%
6th Anti-Money Laundering Directive (AMLD6, Directive (EU) 2018/1673)
9 source controls mapped|15 target controls covered
21%
ISO 8000 — Data Quality
9 source controls mapped|9 target controls covered
21%
FATF Recommendation 16 — Virtual Asset Travel Rule
9 source controls mapped|8 target controls covered
21%
Privacy by Design (PbD) — Seven Foundational Principles
9 source controls mapped|6 target controls covered
21%
BS 65000:2014 — Guidance on Organizational Resilience
9 source controls mapped|6 target controls covered
21%
EU Digital Services Act (Regulation (EU) 2022/2065)
9 source controls mapped|10 target controls covered
21%
EU Machinery Regulation (Regulation (EU) 2023/1230)
9 source controls mapped|15 target controls covered
21%
EU Pay Transparency Directive (Directive (EU) 2023/970)
9 source controls mapped|15 target controls covered
21%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
9 source controls mapped|15 target controls covered
21%
EU Product Liability Directive (Directive (EU) 2023/2845)
9 source controls mapped|15 target controls covered
21%
EU Taxonomy Regulation (Regulation 2020/852)
9 source controls mapped|12 target controls covered
21%
eIDAS 2.0 — EU Digital Identity Regulation
9 source controls mapped|16 target controls covered
21%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
9 source controls mapped|12 target controls covered
21%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
9 source controls mapped|10 target controls covered
21%
African Union Malabo Convention
9 source controls mapped|13 target controls covered
21%
Morocco Data Protection Law (09-08)
9 source controls mapped|12 target controls covered
21%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
9 source controls mapped|14 target controls covered
21%
Peru Personal Data Protection Law (Law No. 29733)
9 source controls mapped|14 target controls covered
21%
Côte d'Ivoire Law No. 2013-450 on the Protection of Personal Data
9 source controls mapped|13 target controls covered
21%
Costa Rica Personal Data Protection Law (Law No. 8968) as amended by Executive Decree No. 42089-MGP
9 source controls mapped|13 target controls covered
21%
Georgia Law on Personal Data Protection (2012)
9 source controls mapped|13 target controls covered
21%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
9 source controls mapped|18 target controls covered
21%
Lithuania Law on Legal Protection of Personal Data (2018)
9 source controls mapped|11 target controls covered
21%
Malta Data Protection Act (Cap. 586, 2018)
9 source controls mapped|16 target controls covered
21%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
9 source controls mapped|11 target controls covered
21%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
9 source controls mapped|14 target controls covered
21%
Russia Federal Law on Personal Data (152-FZ)
9 source controls mapped|9 target controls covered
21%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
9 source controls mapped|10 target controls covered
21%
Angola Personal Data Protection Law (Law No. 22/11)
9 source controls mapped|15 target controls covered
21%
EU Energy Performance of Buildings Directive (EPBD Recast) – Draft Directive (2023/0317 COD)
9 source controls mapped|10 target controls covered
21%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
9 source controls mapped|16 target controls covered
21%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
9 source controls mapped|17 target controls covered
21%
Montenegro Law on Personal Data Protection (2023)
9 source controls mapped|19 target controls covered
21%
North Macedonia Law on Personal Data Protection (2020)
9 source controls mapped|20 target controls covered
21%
EU Carbon Border Adjustment Mechanism (CBAM)
9 source controls mapped|10 target controls covered
21%
EU European Media Freedom Act (EMFA)
9 source controls mapped|13 target controls covered
21%
Senegal Law on Personal Data Protection (Law No. 2008-12)
9 source controls mapped|11 target controls covered
21%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
9 source controls mapped|10 target controls covered
21%
Digital Services Act (DSA) - Regulation (EU) 2022/2065
9 source controls mapped|13 target controls covered
21%
South Korea Credit Information Act
9 source controls mapped|9 target controls covered
21%
MiFID II / MiFIR
9 source controls mapped|9 target controls covered
21%
EU NIS2 Directive — Transport Sector Requirements
9 source controls mapped|11 target controls covered
21%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
9 source controls mapped|15 target controls covered
21%
Jamaica Data Protection Act 2020
9 source controls mapped|9 target controls covered
21%
Mauritius Data Protection Act 2017
9 source controls mapped|13 target controls covered
21%
Fiji Data Protection Bill (2020)
9 source controls mapped|12 target controls covered
21%
Uganda Data Protection and Privacy Act (2019)
9 source controls mapped|12 target controls covered
21%
Tennessee Information Protection Act (TIPA)
9 source controls mapped|10 target controls covered
21%
Connecticut Data Privacy Act (CTDPA)
9 source controls mapped|15 target controls covered
21%
Florida Digital Bill of Rights (FDBR)
9 source controls mapped|12 target controls covered
21%
Saudi PDPL
9 source controls mapped|11 target controls covered
21%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
9 source controls mapped|11 target controls covered
21%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
8 source controls mapped|8 target controls covered
19%
ISO/IEC 27400:2022
8 source controls mapped|8 target controls covered
19%
UK Open Banking Standard
8 source controls mapped|4 target controls covered
19%
CSA STAR (Security, Trust, Assurance, and Risk)
8 source controls mapped|4 target controls covered
19%
Philippines Data Privacy Act (RA 10173)
8 source controls mapped|11 target controls covered
19%
UK Telecommunications (Security) Act 2021
8 source controls mapped|11 target controls covered
19%
South Korea Cloud Security Assurance Program (CSAP)
8 source controls mapped|9 target controls covered
19%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
8 source controls mapped|8 target controls covered
19%
Canada ITSG-33 — IT Security Risk Management
8 source controls mapped|8 target controls covered
19%
New Zealand Information Security Manual (NZISM)
8 source controls mapped|8 target controls covered
19%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
8 source controls mapped|8 target controls covered
19%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
8 source controls mapped|10 target controls covered
19%
FTC GLBA Safeguards Rule (16 CFR Part 314)
8 source controls mapped|7 target controls covered
19%
Philippines Cybercrime Prevention Act (RA 10175)
8 source controls mapped|6 target controls covered
19%
South Korea ISMS-P
8 source controls mapped|6 target controls covered
19%
FAA Cybersecurity Framework for Aviation
8 source controls mapped|7 target controls covered
19%
China Cybersecurity Law (CSL)
8 source controls mapped|6 target controls covered
19%
Bermuda Personal Information Protection Act 2016 (PIPA)
8 source controls mapped|9 target controls covered
19%
Notifiable Data Breaches Scheme (Australia)
8 source controls mapped|8 target controls covered
19%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
8 source controls mapped|7 target controls covered
19%
TISAX — Trusted Information Security Assessment Exchange
8 source controls mapped|8 target controls covered
19%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
8 source controls mapped|7 target controls covered
19%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
8 source controls mapped|7 target controls covered
19%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
8 source controls mapped|10 target controls covered
19%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
8 source controls mapped|15 target controls covered
19%
EU Seveso III Directive (Directive 2012/18/EU)
8 source controls mapped|13 target controls covered
19%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
8 source controls mapped|8 target controls covered
19%
Colombia Data Protection Law (Law 1581 of 2012)
8 source controls mapped|11 target controls covered
19%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
8 source controls mapped|13 target controls covered
19%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
8 source controls mapped|14 target controls covered
19%
South Korea Personal Information Protection Act (PIPA)
8 source controls mapped|19 target controls covered
19%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
8 source controls mapped|14 target controls covered
19%
Armenia Law on Protection of Personal Data (2015)
8 source controls mapped|7 target controls covered
19%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
8 source controls mapped|9 target controls covered
19%
China Personal Information Protection Law (PIPL)
8 source controls mapped|11 target controls covered
19%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
8 source controls mapped|9 target controls covered
19%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
8 source controls mapped|8 target controls covered
19%
Azerbaijan Law on Personal Data (2010)
8 source controls mapped|5 target controls covered
19%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
8 source controls mapped|12 target controls covered
19%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
8 source controls mapped|4 target controls covered
19%
Australia Online Safety Act 2021
8 source controls mapped|5 target controls covered
19%
Australia My Health Records Act 2012
8 source controls mapped|5 target controls covered
19%
Kenya Data Protection Act 2019
8 source controls mapped|9 target controls covered
19%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
8 source controls mapped|10 target controls covered
19%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
8 source controls mapped|5 target controls covered
19%
EU Data Act
8 source controls mapped|5 target controls covered
19%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
8 source controls mapped|6 target controls covered
19%
Wisconsin Data Privacy Act (SB 670)
8 source controls mapped|10 target controls covered
19%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
8 source controls mapped|7 target controls covered
19%
EU Clinical Trials Regulation (CTR 536/2014)
8 source controls mapped|3 target controls covered
19%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
8 source controls mapped|13 target controls covered
19%
EU Data Governance Act (DGA)
8 source controls mapped|5 target controls covered
19%
Jordan Draft Personal Data Protection Law (2022)
8 source controls mapped|11 target controls covered
19%
FedRAMP Rev 5
7 source controls mapped|14 target controls covered
16%
SSAE 18 — Attestation Standards (SOC Reporting)
7 source controls mapped|5 target controls covered
16%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
7 source controls mapped|8 target controls covered
16%
Zambia Data Protection Act (2021)
7 source controls mapped|8 target controls covered
16%
SOC 2
7 source controls mapped|6 target controls covered
16%
AICPA Privacy Management Framework (PMF)
7 source controls mapped|6 target controls covered
16%
Colorado Privacy Act (CPA)
7 source controls mapped|14 target controls covered
16%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
7 source controls mapped|7 target controls covered
16%
EU Taxonomy Regulation
7 source controls mapped|6 target controls covered
16%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
7 source controls mapped|6 target controls covered
16%
EU Web Accessibility Directive (Directive 2016/2102)
7 source controls mapped|7 target controls covered
16%
EU ePrivacy Directive (2002/58/EC)
7 source controls mapped|8 target controls covered
16%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
7 source controls mapped|9 target controls covered
16%
Act on the Implementation of the General Data Protection Regulation (OG 42/2018)
7 source controls mapped|8 target controls covered
16%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
7 source controls mapped|15 target controls covered
16%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
7 source controls mapped|8 target controls covered
16%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
7 source controls mapped|11 target controls covered
16%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
7 source controls mapped|8 target controls covered
16%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
7 source controls mapped|5 target controls covered
16%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
7 source controls mapped|4 target controls covered
16%
EU Audiovisual Media Services Directive (AVMSD, Directive 2010/13/EU as amended by Directive 2018/1808 and Directive (EU) 2023/2586)
7 source controls mapped|6 target controls covered
16%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
7 source controls mapped|8 target controls covered
16%
India Account Aggregator Framework (RBI)
7 source controls mapped|2 target controls covered
16%
South Africa Promotion of Access to Information Act (PAIA)
7 source controls mapped|3 target controls covered
16%
Florida Digital Bill of Rights (SB 262)
7 source controls mapped|3 target controls covered
16%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
7 source controls mapped|5 target controls covered
16%
Korea PIPA
7 source controls mapped|7 target controls covered
16%
ESRB Privacy Certified
7 source controls mapped|6 target controls covered
16%
Israel Protection of Privacy Law (5741-1981)
7 source controls mapped|5 target controls covered
16%
Cook Islands Electronic Transactions Act 2003
7 source controls mapped|7 target controls covered
16%
ISO/IEC 23894:2023
7 source controls mapped|5 target controls covered
16%
Japan APPI
7 source controls mapped|5 target controls covered
16%
UK Age Appropriate Design Code (Children's Code)
7 source controls mapped|7 target controls covered
16%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
7 source controls mapped|4 target controls covered
16%
NIST Privacy Framework 1.0
7 source controls mapped|7 target controls covered
16%
WHO Global Strategy on Digital Health 2020-2025
7 source controls mapped|4 target controls covered
16%
EU AI Liability Directive
7 source controls mapped|7 target controls covered
16%
RICS Professional Standards — Data and Technology in Property
7 source controls mapped|4 target controls covered
16%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
7 source controls mapped|5 target controls covered
16%
ASEAN Guide on AI Governance and Ethics
6 source controls mapped|2 target controls covered
14%
ISO 27001:2022
6 source controls mapped|8 target controls covered
14%
US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements
6 source controls mapped|6 target controls covered
14%
Nevada Gaming Control Board Cybersecurity Requirements
6 source controls mapped|4 target controls covered
14%
Lloyd's Minimum Standards — Cyber Security
6 source controls mapped|4 target controls covered
14%
FTC Safeguards Rule (16 CFR Part 314)
6 source controls mapped|5 target controls covered
14%
COSO Internal Control — Integrated Framework (2013)
6 source controls mapped|3 target controls covered
14%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
6 source controls mapped|3 target controls covered
14%
UK Modern Slavery Act 2015
6 source controls mapped|4 target controls covered
14%
Canada's Anti-Spam Legislation (CASL)
6 source controls mapped|4 target controls covered
14%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
6 source controls mapped|4 target controls covered
14%
CSA CCM v4
6 source controls mapped|12 target controls covered
14%
FTC Health Breach Notification Rule
6 source controls mapped|9 target controls covered
14%
US ITAR and EAR — Export Control and Data Security
6 source controls mapped|9 target controls covered
14%
Oman National Cybersecurity Framework
6 source controls mapped|3 target controls covered
14%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
6 source controls mapped|5 target controls covered
14%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
6 source controls mapped|3 target controls covered
14%
Myanmar Cybersecurity Law (2023)
6 source controls mapped|4 target controls covered
14%
Australia NHMRC National Statement on Ethical Conduct in Human Research
6 source controls mapped|3 target controls covered
14%
NAIC Insurance Data Security Model Law (MDL-668)
6 source controls mapped|7 target controls covered
14%
ISO/IEC 29134:2023
6 source controls mapped|5 target controls covered
14%
ISO/IEC 27014:2020
6 source controls mapped|4 target controls covered
14%
EU Code of Conduct for Research Data Management (GDPR Article 40)
6 source controls mapped|7 target controls covered
14%
ISO/IEC 29100:2024
6 source controls mapped|6 target controls covered
14%
ISO/IEC 38500:2024 — Governance of IT
6 source controls mapped|4 target controls covered
14%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
6 source controls mapped|3 target controls covered
14%
Tonga Communications Act (2015) — Privacy & Data Protection
6 source controls mapped|3 target controls covered
14%
Washington My Health My Data Act (MHMD)
6 source controls mapped|4 target controls covered
14%
Virginia Consumer Data Protection Act (VCDPA)
6 source controls mapped|4 target controls covered
14%
Illinois Biometric Information Privacy Act (BIPA)
6 source controls mapped|3 target controls covered
14%
Modern Slavery Act 2018 (Australia)
6 source controls mapped|5 target controls covered
14%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
5 source controls mapped|6 target controls covered
12%
NIST SP 800-124 Rev 2 — Mobile Device Security
5 source controls mapped|4 target controls covered
12%
French Sapin II Law (Law No. 2016-1691)
5 source controls mapped|4 target controls covered
12%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
5 source controls mapped|3 target controls covered
12%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
5 source controls mapped|7 target controls covered
12%
EAR — Export Administration Regulations
5 source controls mapped|8 target controls covered
12%
European Accessibility Act (Directive (EU) 2019/882)
5 source controls mapped|7 target controls covered
12%
Regulation (EU) 2023/1115 on deforestation-free supply chains
5 source controls mapped|7 target controls covered
12%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
5 source controls mapped|8 target controls covered
12%
NIS2 Directive (Directive (EU) 2022/2555)
5 source controls mapped|9 target controls covered
12%
US SEC Digital Assets and Crypto Regulatory Framework
5 source controls mapped|9 target controls covered
12%
Australia eSafety Commissioner — Online Safety Expectations for Industry
5 source controls mapped|7 target controls covered
12%
Telecommunications Sector Security Reforms (TSSR)
5 source controls mapped|5 target controls covered
12%
Defence Security Principles Framework (DSPF)
5 source controls mapped|12 target controls covered
12%
Protective Security Policy Framework (PSPF) Release 2024
5 source controls mapped|12 target controls covered
12%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
5 source controls mapped|5 target controls covered
12%
NIS2 Directive Implementing Acts
5 source controls mapped|7 target controls covered
12%
Australia AI Ethics Framework
5 source controls mapped|2 target controls covered
12%
Australian Privacy Principles (APPs)
5 source controls mapped|4 target controls covered
12%
PropTech Security Standards — Smart Building Cybersecurity
5 source controls mapped|2 target controls covered
12%
IEEE 7000
5 source controls mapped|2 target controls covered
12%
OECD AI Principles
5 source controls mapped|2 target controls covered
12%
Singapore AI Governance Framework
5 source controls mapped|2 target controls covered
12%
Student Privacy Pledge 2020
5 source controls mapped|4 target controls covered
12%
APEC Cross-Border Privacy Rules (CBPR) System
5 source controls mapped|4 target controls covered
12%
Brazil AI Framework
5 source controls mapped|2 target controls covered
12%
China AI Regulations
5 source controls mapped|2 target controls covered
12%
Privacy and Other Legislation Amendment Act 2024 (Australia)
5 source controls mapped|3 target controls covered
12%
NIST Privacy Framework Version 1.0
5 source controls mapped|4 target controls covered
12%
Japan AI Guidelines
5 source controls mapped|2 target controls covered
12%
UNICEF Policy Guidance on AI for Children (2021)
5 source controls mapped|2 target controls covered
12%
ISO 42001
5 source controls mapped|2 target controls covered
12%
UK AI Regulation Framework
5 source controls mapped|2 target controls covered
12%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
4 source controls mapped|8 target controls covered
9%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
4 source controls mapped|5 target controls covered
9%
CIS Controls v8
4 source controls mapped|9 target controls covered
9%
AWS Well-Architected Security Pillar
4 source controls mapped|5 target controls covered
9%
ISO/IEC 29147:2018
4 source controls mapped|4 target controls covered
9%
OWASP Top 10:2025
4 source controls mapped|4 target controls covered
9%
ISO 27018
4 source controls mapped|5 target controls covered
9%
NIST SP 800-82 Rev 3 — Guide to OT Security
4 source controls mapped|5 target controls covered
9%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
4 source controls mapped|5 target controls covered
9%
ISO 28001:2007 Supply Chain Security Management
4 source controls mapped|7 target controls covered
9%
NIST SP 800-144
4 source controls mapped|5 target controls covered
9%
ISO 27017
4 source controls mapped|5 target controls covered
9%
CAIQ (CSA)
4 source controls mapped|5 target controls covered
9%
NIST SP 800-145
4 source controls mapped|5 target controls covered
9%
NIST Cybersecurity Framework 2.0
4 source controls mapped|8 target controls covered
9%
ISMAP (Japan)
4 source controls mapped|5 target controls covered
9%
Japan FSA Cybersecurity Guidelines for Financial Institutions
4 source controls mapped|5 target controls covered
9%
C2M2
4 source controls mapped|7 target controls covered
9%
EU GMP Annex 11: Computerised Systems
4 source controls mapped|4 target controls covered
9%
MTCS — Multi-Tier Cloud Security (Singapore)
4 source controls mapped|3 target controls covered
9%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
4 source controls mapped|4 target controls covered
9%
RBI Cybersecurity Framework for Banks
4 source controls mapped|4 target controls covered
9%
Kuwait National Cybersecurity Framework
4 source controls mapped|4 target controls covered
9%
UK Gambling Commission — Cyber Resilience Requirements
4 source controls mapped|5 target controls covered
9%
MTCS (Singapore)
4 source controls mapped|5 target controls covered
9%
C5 (Germany)
4 source controls mapped|5 target controls covered
9%
NIST SP 800-190
4 source controls mapped|5 target controls covered
9%
China Data Security Law (DSL)
4 source controls mapped|4 target controls covered
9%
ASD Information Security Manual (ISM)
4 source controls mapped|7 target controls covered
9%
OWASP DevSecOps Maturity Model (DSOMM)
4 source controls mapped|5 target controls covered
9%
BREEAM — Building Research Establishment Environmental Assessment Method
4 source controls mapped|3 target controls covered
9%
NIST SP 800-146
4 source controls mapped|5 target controls covered
9%
SOX 404 / ICFR
4 source controls mapped|1 target controls covered
9%
Equator Principles (EP4, 2020)
4 source controls mapped|2 target controls covered
9%
Canada Artificial Intelligence and Data Act (AIDA)
4 source controls mapped|2 target controls covered
9%
Colorado Artificial Intelligence Act (proposed SB 24-205)
4 source controls mapped|1 target controls covered
9%
Global Cross-Border Privacy Rules (Global CBPR) Forum
4 source controls mapped|3 target controls covered
9%
SASB Standards (ISSB Integrated)
4 source controls mapped|3 target controls covered
9%
SASB Standards
4 source controls mapped|3 target controls covered
9%
ITU-T X.805 — Security Architecture for End-to-End Communications
4 source controls mapped|1 target controls covered
9%
Hong Kong Personal Data (Privacy) Ordinance (PDPO, Cap 486)
4 source controls mapped|2 target controls covered
9%
ENISA Privacy-Enhancing Technologies Reports and Recommendations
4 source controls mapped|2 target controls covered
9%
OWASP Top 10 for LLM Applications 2025
4 source controls mapped|2 target controls covered
9%
Kids Online Safety Act (KOSA)
4 source controls mapped|2 target controls covered
9%
ISO/IEC 27011:2024
4 source controls mapped|7 target controls covered
9%
GLI-33 — Gaming Laboratories International Event Wagering Systems
4 source controls mapped|5 target controls covered
9%
EIOPA Guidelines on ICT Security and Governance (2023)
4 source controls mapped|6 target controls covered
9%
EDM Council CDMC — Cloud Data Management Capability Framework
4 source controls mapped|4 target controls covered
9%
US OFAC Sanctions Compliance Framework
4 source controls mapped|6 target controls covered
9%
Authorised Economic Operator (AEO) Programmes — Global Standards
4 source controls mapped|5 target controls covered
9%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
9%
SQF Code Edition 9 — Safe Quality Food
4 source controls mapped|3 target controls covered
9%
ASIS SPC.1-2009 — Organizational Resilience Standard
3 source controls mapped|2 target controls covered
7%
PCI DSS 4.0
3 source controls mapped|2 target controls covered
7%
SWIFT Customer Security Programme (CSP)
3 source controls mapped|3 target controls covered
7%
ASIC Cyber Resilience Good Practices
3 source controls mapped|4 target controls covered
7%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
3 source controls mapped|5 target controls covered
7%
ISO/IEC 30111:2019
3 source controls mapped|4 target controls covered
7%
OSFI B-13
3 source controls mapped|4 target controls covered
7%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
3 source controls mapped|4 target controls covered
7%
PCI P2PE
3 source controls mapped|4 target controls covered
7%
PCI DSS v4.0
3 source controls mapped|4 target controls covered
7%
C-TPAT — Customs-Trade Partnership Against Terrorism
3 source controls mapped|5 target controls covered
7%
HITECH Act
3 source controls mapped|3 target controls covered
7%
MAS TRM
3 source controls mapped|4 target controls covered
7%
Kenya Data Protection Act
3 source controls mapped|5 target controls covered
7%
GLBA
3 source controls mapped|4 target controls covered
7%
FFIEC IT Examination Handbook
3 source controls mapped|4 target controls covered
7%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|5 target controls covered
7%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
3 source controls mapped|5 target controls covered
7%
PCI SSF
3 source controls mapped|4 target controls covered
7%
SWIFT CSP
3 source controls mapped|4 target controls covered
7%
TIBER-EU (Threat Intelligence-Based Ethical Red Teaming - European Union)
3 source controls mapped|4 target controls covered
7%
Customs-Trade Partnership Against Terrorism (C-TPAT)
3 source controls mapped|4 target controls covered
7%
BCBS 239
3 source controls mapped|6 target controls covered
7%
ISO 22320:2018
3 source controls mapped|6 target controls covered
7%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
3 source controls mapped|6 target controls covered
7%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
3 source controls mapped|2 target controls covered
7%
AICPA SOC 3
3 source controls mapped|4 target controls covered
7%
Cyber Security Act 2024 (Australia)
3 source controls mapped|4 target controls covered
7%
Singapore Cybersecurity Act 2018
3 source controls mapped|2 target controls covered
7%
SWIFT CSCF
3 source controls mapped|6 target controls covered
7%
APRA CPS 234
3 source controls mapped|4 target controls covered
7%
PCI PIN Security
3 source controls mapped|4 target controls covered
7%
APRA Prudential Standard CPS 234 — Information Security (Australia)
3 source controls mapped|4 target controls covered
7%
HKMA SPM
3 source controls mapped|4 target controls covered
7%
PSD2 SCA
3 source controls mapped|4 target controls covered
7%
Defence Industry Security Program (DISP)
3 source controls mapped|3 target controls covered
7%
NIST SP 800-53 Rev 5
3 source controls mapped|7 target controls covered
7%
Open Banking Security
3 source controls mapped|4 target controls covered
7%
IRS Publication 1075 — Tax Information Security Guidelines
3 source controls mapped|2 target controls covered
7%
HKMA Cyber Resilience Assessment Framework (C-RAF)
3 source controls mapped|4 target controls covered
7%
AICPA SOC 1
3 source controls mapped|4 target controls covered
7%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
3 source controls mapped|2 target controls covered
7%
ISO 20000-1
3 source controls mapped|3 target controls covered
7%
ISO 13485
3 source controls mapped|4 target controls covered
7%
US Consumer Product Safety Commission (CPSC) — Connected Product Safety
3 source controls mapped|2 target controls covered
7%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
3 source controls mapped|2 target controls covered
7%
Proposal for a Regulation on the European Health Data Space (EHDS)
3 source controls mapped|4 target controls covered
7%
3GPP Security Architecture (TS 33.501 — 5G Security)
3 source controls mapped|8 target controls covered
7%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|4 target controls covered
7%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
3 source controls mapped|3 target controls covered
7%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
3 source controls mapped|3 target controls covered
7%
AS9100D — Aerospace Quality Management System
3 source controls mapped|4 target controls covered
7%
ISO/IEC 27003:2017
3 source controls mapped|4 target controls covered
7%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
3 source controls mapped|8 target controls covered
7%
IATF 16949:2016 — Quality Management System for Automotive Production
3 source controls mapped|3 target controls covered
7%
ISO 20400:2017 — Sustainable Procurement
3 source controls mapped|5 target controls covered
7%
TNFD Recommendations
3 source controls mapped|4 target controls covered
7%
FDA Quality Management System Regulation (QMSR)
3 source controls mapped|2 target controls covered
7%
ISO/IEC 27006:2024
3 source controls mapped|4 target controls covered
7%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
3 source controls mapped|4 target controls covered
7%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)
3 source controls mapped|3 target controls covered
7%
ECB TIBER-EU Framework
3 source controls mapped|2 target controls covered
7%
GAMP 5 — Good Automated Manufacturing Practice
3 source controls mapped|4 target controls covered
7%
AASB S2 Climate-related Disclosures
3 source controls mapped|3 target controls covered
7%
21 CFR Part 211 — Current Good Manufacturing Practice
3 source controls mapped|2 target controls covered
7%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
3 source controls mapped|3 target controls covered
7%
ICH Q10 — Pharmaceutical Quality System
3 source controls mapped|4 target controls covered
7%
ISO 41001:2018 — Facility Management Systems
3 source controls mapped|5 target controls covered
7%
ISO 39001:2012 — Road Traffic Safety Management
3 source controls mapped|5 target controls covered
7%
ISO 50001:2018 — Energy Management Systems
3 source controls mapped|5 target controls covered
7%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
3 source controls mapped|5 target controls covered
7%
FBI CJIS Security Policy
3 source controls mapped|3 target controls covered
7%
ITAR — International Traffic in Arms Regulations
3 source controls mapped|5 target controls covered
7%
EU Markets in Crypto-Assets Regulation (MiCA)
3 source controls mapped|7 target controls covered
7%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
3 source controls mapped|2 target controls covered
7%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
3 source controls mapped|4 target controls covered
7%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
3 source controls mapped|3 target controls covered
7%
IFRS 17 — Insurance Contracts
3 source controls mapped|2 target controls covered
7%
ICAO Annex 17 — Aviation Security (AVSEC)
3 source controls mapped|3 target controls covered
7%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
3 source controls mapped|4 target controls covered
7%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
3 source controls mapped|3 target controls covered
7%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
2 source controls mapped|4 target controls covered
5%
Australian Energy Sector Cyber Security Framework (AESCSF)
2 source controls mapped|6 target controls covered
5%
API 1164
2 source controls mapped|6 target controls covered
5%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27010:2015
2 source controls mapped|2 target controls covered
5%
Security of Critical Infrastructure Act 2018 (SOCI)
2 source controls mapped|4 target controls covered
5%
ISO 27019
2 source controls mapped|6 target controls covered
5%
BIMCO Cyber Security
2 source controls mapped|6 target controls covered
5%
EASA Part-IS — Information Security in Aviation
2 source controls mapped|3 target controls covered
5%
IEC 62443
2 source controls mapped|6 target controls covered
5%
TSA Pipeline Security
2 source controls mapped|6 target controls covered
5%
NERC CIP
2 source controls mapped|6 target controls covered
5%
DO-326A / ED-202A
2 source controls mapped|6 target controls covered
5%
US Executive Order 14028 — Improving the Nation's Cybersecurity
2 source controls mapped|3 target controls covered
5%
NIST SP 1800-32
2 source controls mapped|6 target controls covered
5%
IEEE 1686
2 source controls mapped|6 target controls covered
5%
DISA Security Technical Implementation Guides (STIGs)
2 source controls mapped|2 target controls covered
5%
APRA CPS 230 Operational Risk Management
2 source controls mapped|3 target controls covered
5%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
2 source controls mapped|3 target controls covered
5%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
2 source controls mapped|3 target controls covered
5%
HIPAA Security Rule
2 source controls mapped|2 target controls covered
5%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|2 target controls covered
5%
ISO 26000:2010
2 source controls mapped|2 target controls covered
5%
WCO Authorised Economic Operator (AEO) Framework
2 source controls mapped|9 target controls covered
5%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
2 source controls mapped|4 target controls covered
5%
FATF 40 Recommendations
2 source controls mapped|4 target controls covered
5%
US Section 508 — ICT Accessibility Standards (Revised 2017)
2 source controls mapped|2 target controls covered
5%
Section 508 — ICT Accessibility (Revised)
2 source controls mapped|1 target controls covered
5%
Extractive Industries Transparency Initiative (EITI) Standard (2023)
2 source controls mapped|1 target controls covered
5%
UK Concordat on Open Research Data (UKRI)
2 source controls mapped|2 target controls covered
5%
COSO Internal Control 2013
2 source controls mapped|2 target controls covered
5%
EN 301 549 — ICT Accessibility Requirements
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27004:2016
2 source controls mapped|3 target controls covered
5%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|3 target controls covered
5%
IEC 60601-1 — Medical Electrical Equipment Safety
2 source controls mapped|2 target controls covered
5%
21 CFR Part 58 — Good Laboratory Practice (GLP)
2 source controls mapped|2 target controls covered
5%
SWIFT CSCF v2024
2 source controls mapped|3 target controls covered
5%
3GPP 5G Security Architecture (TS 33.501)
2 source controls mapped|2 target controls covered
5%
ISO 19011
2 source controls mapped|3 target controls covered
5%
3GPP Security
2 source controls mapped|1 target controls covered
5%
ISO 27002:2022
2 source controls mapped|2 target controls covered
5%
ISO 13485:2016
2 source controls mapped|1 target controls covered
5%
ISO 9001:2015
2 source controls mapped|2 target controls covered
5%
ISO/IEC 42001:2023
2 source controls mapped|2 target controls covered
5%
ISO 22301:2019
2 source controls mapped|2 target controls covered
5%
IEC 62351 — Power Systems Communication Security
2 source controls mapped|1 target controls covered
5%
OWASP ASVS
2 source controls mapped|1 target controls covered
5%
ISO 14001
2 source controls mapped|1 target controls covered
5%
ISO 45001:2018
2 source controls mapped|1 target controls covered
5%
US Foreign Corrupt Practices Act (FCPA)
2 source controls mapped|1 target controls covered
5%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27031:2011
2 source controls mapped|1 target controls covered
5%
ISO/IEC 27007:2020
2 source controls mapped|1 target controls covered
5%
ISO 31000:2018
2 source controls mapped|1 target controls covered
5%
UK Building Safety Act 2022
2 source controls mapped|2 target controls covered
5%
Online Safety Act 2021 (Australia)
2 source controls mapped|3 target controls covered
5%
ISO/SAE 21434
2 source controls mapped|1 target controls covered
5%
ECSS-E-ST-40C: Space Engineering — Software
2 source controls mapped|3 target controls covered
5%
ECSS Software Engineering Standards
2 source controls mapped|3 target controls covered
5%
OWASP MASVS
2 source controls mapped|1 target controls covered
5%
DO-178C / ED-12C — Software Considerations in Airborne Systems
2 source controls mapped|3 target controls covered
5%
ISO 56002
2 source controls mapped|4 target controls covered
5%
ISO 37002:2021 — Whistleblowing Management Systems
2 source controls mapped|3 target controls covered
5%
ISO/IEC 25012:2008 — Data Quality Model
2 source controls mapped|2 target controls covered
5%
NIST SP 800-207
2 source controls mapped|1 target controls covered
5%
O-RAN Alliance Security Specifications (O-RAN.WG11)
2 source controls mapped|3 target controls covered
5%
UK Bribery Act 2010
2 source controls mapped|3 target controls covered
5%
COSO Enterprise Risk Management (ERM) Framework (2017)
2 source controls mapped|2 target controls covered
5%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|3 target controls covered
5%
EN 50126, EN 50128, and EN 50129 — Railway Applications - Reliability, Availability, Maintainability and Safety (RAMS)
2 source controls mapped|3 target controls covered
5%
FedRAMP High
2 source controls mapped|1 target controls covered
5%
NIST SP 800-53 Rev 5 HIGH
2 source controls mapped|1 target controls covered
5%
IRS Publication 1075
2 source controls mapped|1 target controls covered
5%
FedRAMP Moderate
2 source controls mapped|1 target controls covered
5%
NIST SP 800-53 Rev 5 MODERATE
2 source controls mapped|1 target controls covered
5%
NIST SP 800-53 Rev 5 LOW
2 source controls mapped|1 target controls covered
5%
California IoT Security Law
2 source controls mapped|1 target controls covered
5%
ETSI ISG QKD - Quantum Key Distribution
2 source controls mapped|3 target controls covered
5%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
2 source controls mapped|3 target controls covered
5%
W3C Verifiable Credentials (VC) Data Model 2.0
2 source controls mapped|2 target controls covered
5%
NIST SP 800-181
2 source controls mapped|1 target controls covered
5%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
2 source controls mapped|1 target controls covered
5%
Proposal for a Regulation on Cyber Resilience Act (CRA)
2 source controls mapped|1 target controls covered
5%
SIG (Shared Assessments)
2 source controls mapped|1 target controls covered
5%
NIST SP 800-61
2 source controls mapped|1 target controls covered
5%
EDM Council DCAM — Data Management Capability Assessment Model
2 source controls mapped|3 target controls covered
5%
IATA Operational Safety Audit (IOSA) Standards Manual
2 source controls mapped|1 target controls covered
5%
IEC 62304:2015 Medical Device Software Lifecycle Processes
2 source controls mapped|3 target controls covered
5%
NIST SP 800-137
2 source controls mapped|1 target controls covered
5%
NIST SP 800-92
2 source controls mapped|1 target controls covered
5%
BSIMM
2 source controls mapped|1 target controls covered
5%
NIST SP 800-183
2 source controls mapped|1 target controls covered
5%
UK PSTI Act
2 source controls mapped|1 target controls covered
5%
SLSA
2 source controls mapped|1 target controls covered
5%
ISO 26262:2018 — Functional Safety for Road Vehicles
2 source controls mapped|1 target controls covered
5%
ITU Radio Regulations and Space Security Standards
2 source controls mapped|1 target controls covered
5%
NIST SP 800-128
2 source controls mapped|1 target controls covered
5%
NIST SP 800-63
2 source controls mapped|1 target controls covered
5%
NIST SP 800-160
2 source controls mapped|1 target controls covered
5%
NIST SP 800-88
2 source controls mapped|1 target controls covered
5%
OpenSSF Scorecard
2 source controls mapped|1 target controls covered
5%
MITRE D3FEND
2 source controls mapped|1 target controls covered
5%
OWASP SAMM
2 source controls mapped|1 target controls covered
5%
ISO 27043
2 source controls mapped|1 target controls covered
5%
WCAG 2.2
2 source controls mapped|1 target controls covered
5%
NIST SP 800-187
2 source controls mapped|1 target controls covered
5%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
2 source controls mapped|3 target controls covered
5%
EU Payment Services Directive (PSD2) – Under Review
2 source controls mapped|3 target controls covered
5%
NIST SP 800-123
2 source controls mapped|1 target controls covered
5%
COBIT 2019
2 source controls mapped|1 target controls covered
5%
NIST SP 800-161
2 source controls mapped|1 target controls covered
5%
ETSI EN 303 645
2 source controls mapped|1 target controls covered
5%
UNECE WP.29 R156
2 source controls mapped|1 target controls covered
5%
PTES
2 source controls mapped|1 target controls covered
5%
UNECE WP.29 R155
2 source controls mapped|1 target controls covered
5%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
2 source controls mapped|2 target controls covered
5%
ISO 37000:2021 — Governance of Organizations
2 source controls mapped|3 target controls covered
5%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
2 source controls mapped|1 target controls covered
5%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
2 source controls mapped|1 target controls covered
5%
NIST SP 800-115
2 source controls mapped|1 target controls covered
5%
HL7 FHIR Security Framework
2 source controls mapped|1 target controls covered
5%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
2 source controls mapped|3 target controls covered
5%
Science Based Targets initiative (SBTi) Corporate Standard
2 source controls mapped|2 target controls covered
5%
NIST SP 800-150
2 source controls mapped|1 target controls covered
5%
NIST SP 800-218
2 source controls mapped|1 target controls covered
5%
MITRE ATT&CK
2 source controls mapped|1 target controls covered
5%
SSDF (NIST)
2 source controls mapped|1 target controls covered
5%
NIST SP 800-171
1 source controls mapped|4 target controls covered
2%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|2 target controls covered
2%
ANSSI Cybersecurity Framework
1 source controls mapped|3 target controls covered
2%
Ghana Cybersecurity Act
1 source controls mapped|3 target controls covered
2%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
2%
Cyber Essentials Plus
1 source controls mapped|3 target controls covered
2%
NIST SP 800-172
1 source controls mapped|3 target controls covered
2%
DoD Zero Trust Reference Architecture
1 source controls mapped|3 target controls covered
2%
Saudi NCA ECC
1 source controls mapped|3 target controls covered
2%
FISMA
1 source controls mapped|3 target controls covered
2%
CISA Zero Trust Maturity Model
1 source controls mapped|3 target controls covered
2%
FIRST CSIRT Services Framework and Standards
1 source controls mapped|3 target controls covered
2%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|1 target controls covered
2%
NIST SP 800-53A
1 source controls mapped|3 target controls covered
2%
Belgium CyberFundamentals
1 source controls mapped|3 target controls covered
2%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
1 source controls mapped|2 target controls covered
2%
Spain ENS
1 source controls mapped|3 target controls covered
2%
TSA Pipeline Cybersecurity Directives
1 source controls mapped|1 target controls covered
2%
ITIL 4
1 source controls mapped|1 target controls covered
2%
IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|2 target controls covered
2%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
1 source controls mapped|2 target controls covered
2%
EU Better Internet for Kids (BIK+) Strategy
1 source controls mapped|1 target controls covered
2%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|1 target controls covered
2%
Australian Information Security Manual
1 source controls mapped|1 target controls covered
2%
India CERT-In Cyber Security Directions 2022
1 source controls mapped|1 target controls covered
2%
MDS2 (Medical Device)
1 source controls mapped|3 target controls covered
2%
MARS-E
1 source controls mapped|3 target controls covered
2%
UNESCO Recommendation on the Ethics of AI
1 source controls mapped|1 target controls covered
2%
FDA 21 CFR Part 11
1 source controls mapped|3 target controls covered
2%
ISO 27799
1 source controls mapped|3 target controls covered
2%
NIST SP 800-66
1 source controls mapped|3 target controls covered
2%
EU Digital Services Act
1 source controls mapped|1 target controls covered
2%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|3 target controls covered
2%
Critical Raw Materials Act (Proposed Regulation COM(2023) 192)
1 source controls mapped|3 target controls covered
2%
EU Chips Act (Regulation (EU) 2023/1781) — potential incorrect regulation number
1 source controls mapped|3 target controls covered
2%
Responsible Minerals Initiative (RMI) — Responsible Minerals Assurance Process
1 source controls mapped|3 target controls covered
2%
Solvency II
1 source controls mapped|3 target controls covered
2%
UK Security and Emergency Measures Direction (SEMD) — Water Industry
1 source controls mapped|1 target controls covered
2%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|1 target controls covered
2%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
2%
CDP Corporate Questionnaire
1 source controls mapped|1 target controls covered
2%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
1 source controls mapped|3 target controls covered
2%
GS1 Global Standards — Supply Chain Traceability and Data Security
1 source controls mapped|3 target controls covered
2%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
1 source controls mapped|1 target controls covered
2%
Space ISAC (Information Sharing and Analysis Center) — Threat Framework
1 source controls mapped|1 target controls covered
2%
ISO 22301
1 source controls mapped|1 target controls covered
2%
CDP (formerly Carbon Disclosure Project)
1 source controls mapped|1 target controls covered
2%
German Supply Chain Due Diligence Act (LkSG)
1 source controls mapped|3 target controls covered
2%
SA8000:2014 — Social Accountability Standard
1 source controls mapped|1 target controls covered
2%
ISO 22316
1 source controls mapped|1 target controls covered
2%
ISO 22317
1 source controls mapped|1 target controls covered
2%
Sigstore — Software Artifact Signing and Verification
1 source controls mapped|1 target controls covered
2%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
1 source controls mapped|1 target controls covered
2%
ISO 22318
1 source controls mapped|1 target controls covered
2%
US Automated Commercial Environment (ACE) — CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
2%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
1 source controls mapped|3 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|2 target controls covered
2%
EU SFDR (Sustainable Finance Disclosure Regulation)
1 source controls mapped|1 target controls covered
2%
Compare EU In Vitro Diagnostic Medical Devices Regulation (IVDR) with Pakistan Personal Data Protection Bill 2023

Frequently Asked Questions

What is EU In Vitro Diagnostic Medical Devices Regulation (IVDR)?

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) is a compliance framework from European Union with 23 domains and 43 controls. The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746) establishes a comprehensive regulatory framework for in vitro diagnostic medical devices in the European Union. It became applicable on May 26, 2022, replacing the previous IVD Directive (98/79/EC). The IVDR introduces a risk-based classification system for devices, enhanced clinical evidence requirements, improved traceability through UDI, and stricter oversight of manufacturers and notified bodies. Transitional provisions extend until 2028 for certain devices to ensure market continuity. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does EU In Vitro Diagnostic Medical Devices Regulation (IVDR) have?

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) has 43 controls organised across 23 domains. The largest domains are Clinical Evidence and Performance (4 controls), Identification, Traceability and Registration (4 controls), Market Placement and Economic Operators (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does EU In Vitro Diagnostic Medical Devices Regulation (IVDR) map to?

EU In Vitro Diagnostic Medical Devices Regulation (IVDR) maps to 634 other compliance frameworks. The top mapping partners are Pakistan Personal Data Protection Bill 2023 (26% coverage), Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data (26% coverage), GDPR (26% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with EU In Vitro Diagnostic Medical Devices Regulation (IVDR) compliance?

Start your EU In Vitro Diagnostic Medical Devices Regulation (IVDR) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about EU In Vitro Diagnostic Medical Devices Regulation (IVDR) requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 43 controls and track your progress.

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