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EU Medical Devices Regulation (MDR 2017/745)
European Union
v2017/745
4 domains
20 controls
Regulation (EU) 2017/745 on medical devices replaces Directives 90/385/EEC and 93/42/EEC. It establishes a comprehensive regulatory framework for medical devices in the EU covering the entire product lifecycle from design and manufacturing through post-market surveillance. Applies to all medical devices placed on the EU market. Fully applicable since May 2021.
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 (4)
Annex I — General Safety and Performance Requirements
6 controls
Essential safety and performance requirements applicable to all medical devices
| Code | Title |
|---|---|
| MDR-AI-01 | Risk Management |
| MDR-AI-02 | Chemical, Physical and Biological Properties |
| MDR-AI-03 | Infection and Microbial Contamination |
| MDR-AI-04 | Software and Cybersecurity Requirements |
| MDR-AI-05 | Clinical Evaluation |
| MDR-AI-06 | Labelling and Instructions for Use |
Chapter II — Device Classification and Conformity
4 controls
Device classification, conformity assessment procedures, and CE marking
| Code | Title |
|---|---|
| MDR-II-01 | Device Classification Rules |
| MDR-II-02 | Conformity Assessment Procedures |
| MDR-II-03 | CE Marking Requirements |
| MDR-II-04 | EU Declaration of Conformity |
Chapter III — Economic Operators
5 controls
Obligations of manufacturers, authorized representatives, importers, and distributors
| Code | Title |
|---|---|
| MDR-III-01 | Manufacturer General Obligations |
| MDR-III-02 | Person Responsible for Regulatory Compliance |
| MDR-III-03 | Unique Device Identification (UDI) |
| MDR-III-04 | Traceability Requirements |
| MDR-III-05 | Authorized Representative Obligations |
Chapter VII — Post-Market Surveillance
5 controls
Post-market surveillance, vigilance, and market surveillance requirements
| Code | Title |
|---|---|
| MDR-VII-01 | Post-Market Surveillance System |
| MDR-VII-02 | Periodic Safety Update Report (PSUR) |
| MDR-VII-03 | Serious Incident Reporting |
| MDR-VII-04 | Field Safety Corrective Actions (FSCA) |
| MDR-VII-05 | Post-Market Clinical Follow-up (PMCF) |
Maps to 407 other frameworks
20 total controls
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
8 source controls mapped|9 target controls covered
40%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
8 source controls mapped|6 target controls covered
40%
ICH E6(R3) — Good Clinical Practice
8 source controls mapped|5 target controls covered
40%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
8 source controls mapped|6 target controls covered
40%
Notifiable Data Breaches Scheme (Australia)
8 source controls mapped|4 target controls covered
40%
EU Digital Markets Act
8 source controls mapped|4 target controls covered
40%
FTC Health Breach Notification Rule
8 source controls mapped|4 target controls covered
40%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
8 source controls mapped|4 target controls covered
40%
EAR — Export Administration Regulations
8 source controls mapped|4 target controls covered
40%
European Accessibility Act (Directive (EU) 2019/882)
8 source controls mapped|5 target controls covered
40%
EU Deforestation-Free Products Regulation (EUDR)
8 source controls mapped|4 target controls covered
40%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
8 source controls mapped|4 target controls covered
40%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
8 source controls mapped|6 target controls covered
40%
US ITAR and EAR — Export Control and Data Security
8 source controls mapped|4 target controls covered
40%
US SEC Digital Assets and Crypto Regulatory Framework
8 source controls mapped|5 target controls covered
40%
Australia Consumer Data Right — Banking (CDR)
8 source controls mapped|4 target controls covered
40%
Australia eSafety Commissioner — Online Safety Expectations for Industry
8 source controls mapped|4 target controls covered
40%
BS 65000:2014 — Guidance on Organizational Resilience
8 source controls mapped|6 target controls covered
40%
TEFCA — Trusted Exchange Framework and Common Agreement
8 source controls mapped|5 target controls covered
40%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
8 source controls mapped|8 target controls covered
40%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
7 source controls mapped|8 target controls covered
35%
FDA Quality Management System Regulation (QMSR)
7 source controls mapped|7 target controls covered
35%
Australian Energy Sector Cyber Security Framework (AESCSF)
7 source controls mapped|7 target controls covered
35%
CSA CCM v4
7 source controls mapped|4 target controls covered
35%
GLI-33 — Gaming Laboratories International Event Wagering Systems
7 source controls mapped|4 target controls covered
35%
Oman National Cybersecurity Framework
7 source controls mapped|5 target controls covered
35%
New Zealand Information Security Manual (NZISM)
7 source controls mapped|3 target controls covered
35%
ILO Nursing Personnel Convention C149 (1977)
7 source controls mapped|4 target controls covered
35%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
7 source controls mapped|4 target controls covered
35%
ISO 8000 — Data Quality
7 source controls mapped|4 target controls covered
35%
FATF Recommendation 16 — Virtual Asset Travel Rule
7 source controls mapped|4 target controls covered
35%
Privacy by Design (PbD) — Seven Foundational Principles
7 source controls mapped|4 target controls covered
35%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
7 source controls mapped|5 target controls covered
35%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
6 source controls mapped|9 target controls covered
30%
IEC 62304:2015 Medical Device Software Lifecycle Processes
6 source controls mapped|4 target controls covered
30%
AS9100D — Aerospace Quality Management System
6 source controls mapped|9 target controls covered
30%
ISO/IEC 27003:2017
6 source controls mapped|9 target controls covered
30%
WCO Authorised Economic Operator (AEO) Framework
6 source controls mapped|4 target controls covered
30%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
6 source controls mapped|7 target controls covered
30%
UK Telecommunications (Security) Act 2021
6 source controls mapped|5 target controls covered
30%
CDP (formerly Carbon Disclosure Project)
6 source controls mapped|5 target controls covered
30%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
6 source controls mapped|3 target controls covered
30%
South Korea ISMS-P
6 source controls mapped|3 target controls covered
30%
Aged Care Quality Standards (Australia)
6 source controls mapped|4 target controls covered
30%
ISO 28001:2007 Supply Chain Security Management
6 source controls mapped|6 target controls covered
30%
TISAX — Trusted Information Security Assessment Exchange
6 source controls mapped|4 target controls covered
30%
ICH Q10 — Pharmaceutical Quality System
6 source controls mapped|5 target controls covered
30%
Florida Digital Bill of Rights (SB 262)
6 source controls mapped|2 target controls covered
30%
C5 (Germany)
6 source controls mapped|2 target controls covered
30%
ISO 27017
6 source controls mapped|2 target controls covered
30%
OWASP DevSecOps Maturity Model (DSOMM)
6 source controls mapped|3 target controls covered
30%
CAIQ (CSA)
6 source controls mapped|2 target controls covered
30%
ISMAP (Japan)
6 source controls mapped|2 target controls covered
30%
ISO 27018
6 source controls mapped|2 target controls covered
30%
AWS Well-Architected Security Pillar
6 source controls mapped|2 target controls covered
30%
Azure Security Benchmark
6 source controls mapped|2 target controls covered
30%
NIST SP 800-144
6 source controls mapped|2 target controls covered
30%
NIST SP 800-190
6 source controls mapped|2 target controls covered
30%
NIST SP 800-145
6 source controls mapped|2 target controls covered
30%
NIST SP 800-146
6 source controls mapped|2 target controls covered
30%
MTCS (Singapore)
6 source controls mapped|2 target controls covered
30%
C-TPAT — Customs-Trade Partnership Against Terrorism
5 source controls mapped|2 target controls covered
25%
BRCGS Global Standard for Food Safety Issue 9
5 source controls mapped|8 target controls covered
25%
ISO/IEC 27006:2024
5 source controls mapped|4 target controls covered
25%
SQF Code Edition 9 — Safe Quality Food
5 source controls mapped|4 target controls covered
25%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
5 source controls mapped|3 target controls covered
25%
DO-178C / ED-12C — Software Considerations in Airborne Systems
5 source controls mapped|4 target controls covered
25%
EU European Health Data Space (EHDS)
5 source controls mapped|3 target controls covered
25%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
5 source controls mapped|5 target controls covered
25%
ASEAN Data Management Framework
5 source controls mapped|4 target controls covered
25%
ISO 31000
4 source controls mapped|4 target controls covered
20%
Brazil AI Framework
4 source controls mapped|4 target controls covered
20%
FAA Cybersecurity Framework for Aviation
4 source controls mapped|7 target controls covered
20%
Japan FSA Cybersecurity Guidelines for Financial Institutions
4 source controls mapped|4 target controls covered
20%
RBI Cybersecurity Framework for Banks
4 source controls mapped|4 target controls covered
20%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|4 target controls covered
20%
AASB S2 Climate-related Disclosures
4 source controls mapped|6 target controls covered
20%
BIMCO Cyber Security
4 source controls mapped|2 target controls covered
20%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
4 source controls mapped|3 target controls covered
20%
HKMA Cyber Resilience Assessment Framework (C-RAF)
4 source controls mapped|4 target controls covered
20%
EU AI Act
4 source controls mapped|4 target controls covered
20%
Japan AI Guidelines
4 source controls mapped|4 target controls covered
20%
ISO 27005
4 source controls mapped|4 target controls covered
20%
IEEE 7000
4 source controls mapped|4 target controls covered
20%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
20%
Australia AI Ethics Framework
4 source controls mapped|4 target controls covered
20%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|4 target controls covered
20%
Defence Security Principles Framework (DSPF)
4 source controls mapped|5 target controls covered
20%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|5 target controls covered
20%
China AI Regulations
4 source controls mapped|4 target controls covered
20%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
4 source controls mapped|2 target controls covered
20%
C2M2
4 source controls mapped|2 target controls covered
20%
EASA Part-IS — Information Security in Aviation
4 source controls mapped|4 target controls covered
20%
API 1164
4 source controls mapped|2 target controls covered
20%
ASIC Cyber Resilience Good Practices
4 source controls mapped|3 target controls covered
20%
ISO 42001
4 source controls mapped|4 target controls covered
20%
FFIEC Cybersecurity Assessment Tool (CAT)
4 source controls mapped|3 target controls covered
20%
ASD Information Security Manual (ISM)
4 source controls mapped|3 target controls covered
20%
NIST AI Risk Management Framework (AI RMF 1.0)
4 source controls mapped|3 target controls covered
20%
NIST AI 600-1 Generative AI Profile
4 source controls mapped|3 target controls covered
20%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
4 source controls mapped|2 target controls covered
20%
ISO 27019
4 source controls mapped|2 target controls covered
20%
Canada Artificial Intelligence and Data Act (AIDA)
4 source controls mapped|2 target controls covered
20%
IEC 62443
4 source controls mapped|2 target controls covered
20%
EDM Council DCAM — Data Management Capability Assessment Model
4 source controls mapped|2 target controls covered
20%
EIOPA Guidelines on ICT Security and Governance (2020)
4 source controls mapped|4 target controls covered
20%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
4 source controls mapped|4 target controls covered
20%
FedRAMP Rev 5
4 source controls mapped|3 target controls covered
20%
DO-326A
4 source controls mapped|2 target controls covered
20%
CSA STAR (Security, Trust, Assurance, and Risk)
4 source controls mapped|2 target controls covered
20%
COSO ERM
4 source controls mapped|4 target controls covered
20%
Global Cross-Border Privacy Rules (Global CBPR) Forum
4 source controls mapped|2 target controls covered
20%
ISO 20400:2017 — Sustainable Procurement
4 source controls mapped|2 target controls covered
20%
Colorado AI Act (SB 24-205)
4 source controls mapped|2 target controls covered
20%
IEEE 1686
4 source controls mapped|2 target controls covered
20%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
4 source controls mapped|2 target controls covered
20%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
4 source controls mapped|2 target controls covered
20%
German Supply Chain Due Diligence Act (LkSG)
4 source controls mapped|2 target controls covered
20%
NERC CIP
4 source controls mapped|2 target controls covered
20%
NIST Cybersecurity Framework 2.0
4 source controls mapped|4 target controls covered
20%
NIST SP 800-37
4 source controls mapped|4 target controls covered
20%
NIST SP 800-53 Rev 5
4 source controls mapped|4 target controls covered
20%
TSA Pipeline Security
4 source controls mapped|3 target controls covered
20%
NIS2 Directive
4 source controls mapped|2 target controls covered
20%
Singapore AI Governance Framework
4 source controls mapped|4 target controls covered
20%
OECD AI Principles
4 source controls mapped|4 target controls covered
20%
NIST Privacy Framework 1.0
4 source controls mapped|4 target controls covered
20%
NIST SP 800-30
4 source controls mapped|4 target controls covered
20%
NIST SP 800-39
4 source controls mapped|4 target controls covered
20%
NIST SP 800-82 Rev 3 — Guide to OT Security
4 source controls mapped|3 target controls covered
20%
Telecommunications Sector Security Reforms (TSSR)
4 source controls mapped|3 target controls covered
20%
MTCS — Multi-Tier Cloud Security (Singapore)
4 source controls mapped|2 target controls covered
20%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
4 source controls mapped|4 target controls covered
20%
UK AI Regulation Framework
4 source controls mapped|4 target controls covered
20%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
4 source controls mapped|2 target controls covered
20%
SASB Standards (ISSB Integrated)
4 source controls mapped|4 target controls covered
20%
SASB Standards
4 source controls mapped|4 target controls covered
20%
EU Markets in Crypto-Assets Regulation (MiCA)
4 source controls mapped|3 target controls covered
20%
Security of Critical Infrastructure Act 2018 (SOCI)
4 source controls mapped|4 target controls covered
20%
NIST SP 1800-32
4 source controls mapped|2 target controls covered
20%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
4 source controls mapped|2 target controls covered
20%
Canada ITSG-33 — IT Security Risk Management
4 source controls mapped|4 target controls covered
20%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
4 source controls mapped|2 target controls covered
20%
South Korea Cloud Security Assurance Program (CSAP)
4 source controls mapped|2 target controls covered
20%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
4 source controls mapped|2 target controls covered
20%
ISO 45001
4 source controls mapped|2 target controls covered
20%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
4 source controls mapped|2 target controls covered
20%
ISO 22000
4 source controls mapped|2 target controls covered
20%
3GPP Security Architecture (TS 33.501 — 5G Security)
3 source controls mapped|3 target controls covered
15%
Singapore Model AI Governance Framework (2nd Edition)
3 source controls mapped|2 target controls covered
15%
NIS2 Directive Implementing Acts
3 source controls mapped|4 target controls covered
15%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
3 source controls mapped|3 target controls covered
15%
Customs-Trade Partnership Against Terrorism (C-TPAT)
3 source controls mapped|3 target controls covered
15%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
3 source controls mapped|3 target controls covered
15%
EU Chips Act (Regulation (EU) 2023/1781)
3 source controls mapped|3 target controls covered
15%
HITECH Act
3 source controls mapped|3 target controls covered
15%
EU Clinical Trials Regulation (CTR 536/2014)
3 source controls mapped|3 target controls covered
15%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
15%
Wisconsin Data Privacy Act (SB 670)
3 source controls mapped|1 target controls covered
15%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|1 target controls covered
15%
WELL Building Standard v2 (International WELL Building Institute)
3 source controls mapped|1 target controls covered
15%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
3 source controls mapped|1 target controls covered
15%
HIPAA Security Rule
3 source controls mapped|6 target controls covered
15%
Australia My Health Records Act 2012
3 source controls mapped|3 target controls covered
15%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|1 target controls covered
15%
Washington My Health My Data Act (MHMD)
3 source controls mapped|1 target controls covered
15%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|1 target controls covered
15%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
3 source controls mapped|1 target controls covered
15%
Connecticut Data Privacy Act (CTDPA)
3 source controls mapped|1 target controls covered
15%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|1 target controls covered
15%
NAIC Insurance Data Security Model Law (MDL-668)
3 source controls mapped|1 target controls covered
15%
Modern Slavery Act 2018 (Australia)
3 source controls mapped|1 target controls covered
15%
MDS2 (Medical Device)
3 source controls mapped|3 target controls covered
15%
Australia NHMRC National Statement on Ethical Conduct in Human Research
3 source controls mapped|1 target controls covered
15%
Bahrain PDPL
3 source controls mapped|1 target controls covered
15%
EU Machinery Regulation (Regulation (EU) 2023/1230)
3 source controls mapped|1 target controls covered
15%
ISO 27701
3 source controls mapped|1 target controls covered
15%
COPPA
3 source controls mapped|1 target controls covered
15%
Delaware Personal Data Privacy Act
3 source controls mapped|1 target controls covered
15%
Kenya DPA
3 source controls mapped|1 target controls covered
15%
CCPA/CPRA
3 source controls mapped|1 target controls covered
15%
GRI Standards
3 source controls mapped|1 target controls covered
15%
LGPD
3 source controls mapped|1 target controls covered
15%
India DPDP Act
3 source controls mapped|1 target controls covered
15%
CSRD
3 source controls mapped|1 target controls covered
15%
Privacy Act 1988 (Australia)
3 source controls mapped|1 target controls covered
15%
Iceland DPA
3 source controls mapped|1 target controls covered
15%
Kentucky Consumer Data Protection Act
3 source controls mapped|1 target controls covered
15%
Colombia Habeas Data Law
3 source controls mapped|1 target controls covered
15%
Turkey KVKK
3 source controls mapped|1 target controls covered
15%
Chile DPL
3 source controls mapped|1 target controls covered
15%
Indonesia PDP Law
3 source controls mapped|1 target controls covered
15%
ISSB Standards
3 source controls mapped|1 target controls covered
15%
Maryland Online Data Privacy Act
3 source controls mapped|1 target controls covered
15%
Argentina PDPA
3 source controls mapped|1 target controls covered
15%
FATF 40 Recommendations
3 source controls mapped|1 target controls covered
15%
Switzerland FADP
3 source controls mapped|1 target controls covered
15%
EDM Council CDMC — Cloud Data Management Capabilities Framework
3 source controls mapped|1 target controls covered
15%
Ecuador LOPDP
3 source controls mapped|1 target controls covered
15%
APEC Cross-Border Privacy Rules (CBPR) System
3 source controls mapped|1 target controls covered
15%
Liechtenstein DPA
3 source controls mapped|1 target controls covered
15%
FERPA
3 source controls mapped|1 target controls covered
15%
APPI
3 source controls mapped|1 target controls covered
15%
Indiana Consumer Data Protection Act
3 source controls mapped|1 target controls covered
15%
Connecticut DPA
3 source controls mapped|1 target controls covered
15%
Colorado Privacy Act
3 source controls mapped|1 target controls covered
15%
Iowa Consumer Data Protection Act
3 source controls mapped|1 target controls covered
15%
Dominican Republic DPL
3 source controls mapped|1 target controls covered
15%
ISO 14001
3 source controls mapped|1 target controls covered
15%
ESRB Privacy Certified Programme
3 source controls mapped|1 target controls covered
15%
Jamaica DPA
3 source controls mapped|1 target controls covered
15%
New Zealand Privacy Act
3 source controls mapped|1 target controls covered
15%
Utah Consumer Privacy Act
3 source controls mapped|1 target controls covered
15%
Nigeria NDPR
3 source controls mapped|1 target controls covered
15%
Nebraska Data Privacy Act
3 source controls mapped|1 target controls covered
15%
PDPA Singapore
3 source controls mapped|1 target controls covered
15%
Mauritius DPA
3 source controls mapped|1 target controls covered
15%
TCFD Recommendations
3 source controls mapped|1 target controls covered
15%
UAE PDPL
3 source controls mapped|1 target controls covered
15%
Philippines Data Privacy Act (RA 10173)
3 source controls mapped|1 target controls covered
15%
POPIA
3 source controls mapped|1 target controls covered
15%
Norway PDPA
3 source controls mapped|1 target controls covered
15%
South Korea PIPA
3 source controls mapped|1 target controls covered
15%
Taiwan PDPA
3 source controls mapped|1 target controls covered
15%
Philippines DPA
3 source controls mapped|1 target controls covered
15%
Rwanda DPL
3 source controls mapped|1 target controls covered
15%
New Jersey Data Privacy Act
3 source controls mapped|1 target controls covered
15%
Virginia CDPA
3 source controls mapped|1 target controls covered
15%
Minnesota Consumer Data Privacy Act
3 source controls mapped|1 target controls covered
15%
NIST SP 800-122
3 source controls mapped|1 target controls covered
15%
Oregon Consumer Privacy Act
3 source controls mapped|1 target controls covered
15%
Qatar DPL
3 source controls mapped|1 target controls covered
15%
Tennessee IPA
3 source controls mapped|1 target controls covered
15%
PDPA Thailand
3 source controls mapped|1 target controls covered
15%
Uruguay DPL
3 source controls mapped|1 target controls covered
15%
PIPEDA
3 source controls mapped|1 target controls covered
15%
Peru DPL
3 source controls mapped|1 target controls covered
15%
Mexico LFPDPPP
3 source controls mapped|1 target controls covered
15%
Texas Data Privacy Act
3 source controls mapped|1 target controls covered
15%
Saudi Arabia PDPL
3 source controls mapped|1 target controls covered
15%
Vietnam PDPD
3 source controls mapped|1 target controls covered
15%
Malaysia PDPA 2010
3 source controls mapped|1 target controls covered
15%
EU SFDR (Sustainable Finance Disclosure Regulation)
3 source controls mapped|1 target controls covered
15%
New Hampshire Privacy Act
3 source controls mapped|1 target controls covered
15%
UK Data Protection Act 2018
3 source controls mapped|1 target controls covered
15%
Montana Consumer Data Privacy Act
3 source controls mapped|1 target controls covered
15%
China PIPL
3 source controls mapped|1 target controls covered
15%
ISO 9001
3 source controls mapped|3 target controls covered
15%
IATF 16949:2016 — Quality Management System for Automotive Production
3 source controls mapped|2 target controls covered
15%
ISO 37301
3 source controls mapped|1 target controls covered
15%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
3 source controls mapped|1 target controls covered
15%
ISO 30401
3 source controls mapped|1 target controls covered
15%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
3 source controls mapped|1 target controls covered
15%
ISO 55001
3 source controls mapped|1 target controls covered
15%
ITAR — International Traffic in Arms Regulations
3 source controls mapped|1 target controls covered
15%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
3 source controls mapped|1 target controls covered
15%
Voluntary Principles on Security and Human Rights (VPs)
3 source controls mapped|1 target controls covered
15%
EU Better Internet for Kids (BIK+) Strategy
3 source controls mapped|1 target controls covered
15%
ISO 19011
3 source controls mapped|1 target controls covered
15%
ICAO Annex 17 — Aviation Security (AVSEC)
3 source controls mapped|1 target controls covered
15%
ISO/IEC 27014:2020
3 source controls mapped|1 target controls covered
15%
ISO 56002
3 source controls mapped|3 target controls covered
15%
ISO 41001:2018 — Facility Management Systems
3 source controls mapped|3 target controls covered
15%
ISO 39001:2012 — Road Traffic Safety Management
3 source controls mapped|3 target controls covered
15%
ISO 37002:2021 — Whistleblowing Management Systems
3 source controls mapped|3 target controls covered
15%
ISO 50001:2018 — Energy Management Systems
3 source controls mapped|3 target controls covered
15%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
3 source controls mapped|3 target controls covered
15%
ISO 37001
3 source controls mapped|1 target controls covered
15%
UK FCA/PRA Operational Resilience Framework
3 source controls mapped|1 target controls covered
15%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
3 source controls mapped|2 target controls covered
15%
IRS Publication 1075 — Tax Information Security Guidelines
3 source controls mapped|1 target controls covered
15%
SA8000:2014 — Social Accountability Standard
3 source controls mapped|1 target controls covered
15%
AICPA Privacy Management Framework (PMF)
3 source controls mapped|1 target controls covered
15%
ASD Strategies to Mitigate Cyber Security Incidents
3 source controls mapped|2 target controls covered
15%
Cyber Essentials Plus
3 source controls mapped|1 target controls covered
15%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|1 target controls covered
15%
ANSSI Cybersecurity Framework
3 source controls mapped|1 target controls covered
15%
ISO 27001:2022
3 source controls mapped|1 target controls covered
15%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
3 source controls mapped|1 target controls covered
15%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
3 source controls mapped|1 target controls covered
15%
Belgium CyberFundamentals
3 source controls mapped|1 target controls covered
15%
ISO/IEC 27400:2022
3 source controls mapped|1 target controls covered
15%
DoD Zero Trust Reference Architecture
3 source controls mapped|1 target controls covered
15%
FTC Safeguards Rule (16 CFR Part 314)
3 source controls mapped|1 target controls covered
15%
Ghana Cybersecurity Act
3 source controls mapped|1 target controls covered
15%
SWIFT Customer Security Programme (CSP)
3 source controls mapped|1 target controls covered
15%
NIST SP 800-171A — Assessing CUI Security Requirements
3 source controls mapped|1 target controls covered
15%
BSI IT-Grundschutz
3 source controls mapped|1 target controls covered
15%
CISA Zero Trust Maturity Model
3 source controls mapped|1 target controls covered
15%
Spain ENS
3 source controls mapped|1 target controls covered
15%
CMMC 2.0
3 source controls mapped|1 target controls covered
15%
FISMA
3 source controls mapped|1 target controls covered
15%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
3 source controls mapped|1 target controls covered
15%
NIST SP 800-171
3 source controls mapped|1 target controls covered
15%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
3 source controls mapped|1 target controls covered
15%
UK Gambling Commission — Cyber Resilience Requirements
3 source controls mapped|2 target controls covered
15%
Saudi NCA ECC
3 source controls mapped|1 target controls covered
15%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
3 source controls mapped|1 target controls covered
15%
NIST SP 800-172
3 source controls mapped|1 target controls covered
15%
DISA Security Technical Implementation Guides (STIGs)
3 source controls mapped|1 target controls covered
15%
NIST SP 800-53A
3 source controls mapped|1 target controls covered
15%
TSA Pipeline Cybersecurity Directives
3 source controls mapped|2 target controls covered
15%
PropTech Security Standards — Smart Building Cybersecurity
3 source controls mapped|1 target controls covered
15%
GS1 Global Standards — Supply Chain Traceability and Data Security
2 source controls mapped|2 target controls covered
10%
ASIS SPC.1-2009 — Organizational Resilience Standard
2 source controls mapped|2 target controls covered
10%
US OFAC Sanctions Compliance Framework
2 source controls mapped|3 target controls covered
10%
21 CFR Part 211 — Current Good Manufacturing Practice
2 source controls mapped|3 target controls covered
10%
21 CFR Part 58 — Good Laboratory Practice (GLP)
2 source controls mapped|1 target controls covered
10%
EU Digital Services Act
2 source controls mapped|1 target controls covered
10%
FSSC 22000 — Food Safety System Certification
2 source controls mapped|3 target controls covered
10%
ISO/IEC 25012:2008 — Data Quality Model
2 source controls mapped|1 target controls covered
10%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|3 target controls covered
5%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
1 source controls mapped|1 target controls covered
5%
APRA CPS 234
1 source controls mapped|3 target controls covered
5%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|3 target controls covered
5%
Kuwait National Cybersecurity Framework
1 source controls mapped|3 target controls covered
5%
GLBA
1 source controls mapped|3 target controls covered
5%
ICMM Mining Principles (2024 Update)
1 source controls mapped|1 target controls covered
5%
DORA
1 source controls mapped|3 target controls covered
5%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
1 source controls mapped|5 target controls covered
5%
EU GMP Annex 11 — Computerised Systems
1 source controls mapped|1 target controls covered
5%
TNFD Recommendations
1 source controls mapped|4 target controls covered
5%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
1 source controls mapped|1 target controls covered
5%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
5%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
5%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|2 target controls covered
5%
HKMA SPM
1 source controls mapped|3 target controls covered
5%
APRA CPS 220 Risk Management
1 source controls mapped|3 target controls covered
5%
BCBS 239
1 source controls mapped|3 target controls covered
5%
FFIEC IT Examination Handbook
1 source controls mapped|3 target controls covered
5%
APRA CPS 230 Operational Risk Management
1 source controls mapped|3 target controls covered
5%
FBI CJIS Security Policy
1 source controls mapped|1 target controls covered
5%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
1 source controls mapped|2 target controls covered
5%
ISO/IEC 23894:2023
1 source controls mapped|3 target controls covered
5%
ISO 37000:2021 — Governance of Organizations
1 source controls mapped|2 target controls covered
5%
MAS TRM
1 source controls mapped|3 target controls covered
5%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|3 target controls covered
5%
ISO/IEC 38500:2024 — Governance of IT
1 source controls mapped|1 target controls covered
5%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
1 source controls mapped|2 target controls covered
5%
ISO 22320:2018
1 source controls mapped|1 target controls covered
5%
NIST Privacy Framework Version 1.0
1 source controls mapped|2 target controls covered
5%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
1 source controls mapped|1 target controls covered
5%
EU Carbon Border Adjustment Mechanism (CBAM)
1 source controls mapped|1 target controls covered
5%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
1 source controls mapped|1 target controls covered
5%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
1 source controls mapped|1 target controls covered
5%
EU Digital Services Act — Online Gaming Platform Requirements
1 source controls mapped|1 target controls covered
5%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
1 source controls mapped|1 target controls covered
5%
EU European Media Freedom Act (EMFA)
1 source controls mapped|1 target controls covered
5%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
1 source controls mapped|1 target controls covered
5%
EU Pay Transparency Directive (Directive 2023/970)
1 source controls mapped|1 target controls covered
5%
EU Platform Work Directive (Directive 2024/2831)
1 source controls mapped|1 target controls covered
5%
EU Product Liability Directive (Directive (EU) 2024/2853)
1 source controls mapped|1 target controls covered
5%
EU Seveso III Directive (Directive 2012/18/EU)
1 source controls mapped|1 target controls covered
5%
EU Taxonomy Regulation (Regulation 2020/852)
1 source controls mapped|1 target controls covered
5%
EU Taxonomy Regulation
1 source controls mapped|1 target controls covered
5%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
1 source controls mapped|1 target controls covered
5%
EU ePrivacy Directive (2002/58/EC)
1 source controls mapped|1 target controls covered
5%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
1 source controls mapped|1 target controls covered
5%
African Union Malabo Convention
1 source controls mapped|1 target controls covered
5%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
1 source controls mapped|1 target controls covered
5%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
1 source controls mapped|1 target controls covered
5%
Peru Personal Data Protection Law (Law No. 29733)
1 source controls mapped|1 target controls covered
5%
Costa Rica Personal Data Protection Law (Law No. 8968)
1 source controls mapped|1 target controls covered
5%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
1 source controls mapped|1 target controls covered
5%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
1 source controls mapped|1 target controls covered
5%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
1 source controls mapped|1 target controls covered
5%
Uzbekistan Law on Personal Data (No. ZRU-547)
1 source controls mapped|1 target controls covered
5%
Georgia Law on Personal Data Protection (2012)
1 source controls mapped|1 target controls covered
5%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
1 source controls mapped|1 target controls covered
5%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
1 source controls mapped|1 target controls covered
5%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
1 source controls mapped|1 target controls covered
5%
Montenegro Law on Personal Data Protection (2023)
1 source controls mapped|1 target controls covered
5%
Lithuania Law on Legal Protection of Personal Data (2018)
1 source controls mapped|1 target controls covered
5%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
1 source controls mapped|1 target controls covered
5%
Malta Data Protection Act (Cap. 586, 2018)
1 source controls mapped|1 target controls covered
5%
Oman Personal Data Protection Law (Royal Decree 6/2022)
1 source controls mapped|1 target controls covered
5%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
1 source controls mapped|1 target controls covered
5%
South Korea Personal Information Protection Act (PIPA)
1 source controls mapped|1 target controls covered
5%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
1 source controls mapped|1 target controls covered
5%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
1 source controls mapped|1 target controls covered
5%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
1 source controls mapped|1 target controls covered
5%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
5%
PCI PIN Security
1 source controls mapped|3 target controls covered
5%
OSFI B-13
1 source controls mapped|3 target controls covered
5%
Authorised Economic Operator (AEO) Programmes — Global Standards
1 source controls mapped|1 target controls covered
5%
SWIFT CSCF
1 source controls mapped|3 target controls covered
5%
Open Banking Security
1 source controls mapped|3 target controls covered
5%
AICPA SOC 1
1 source controls mapped|3 target controls covered
5%
PCI SSF
1 source controls mapped|3 target controls covered
5%
PCI P2PE
1 source controls mapped|3 target controls covered
5%
Solvency II
1 source controls mapped|3 target controls covered
5%
SWIFT CSP
1 source controls mapped|3 target controls covered
5%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|3 target controls covered
5%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|3 target controls covered
5%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
1 source controls mapped|2 target controls covered
5%
ECB TIBER-EU
1 source controls mapped|3 target controls covered
5%
COSO Enterprise Risk Management (ERM) Framework (2017)
1 source controls mapped|3 target controls covered
5%
AICPA SOC 3
1 source controls mapped|3 target controls covered
5%
SEC Cybersecurity Disclosure Rules
1 source controls mapped|2 target controls covered
5%
OECD AI Principles (2024 Update)
1 source controls mapped|1 target controls covered
5%
EU PSD3 and Payment Services Regulation (Proposed)
1 source controls mapped|1 target controls covered
5%
PSD2 SCA
1 source controls mapped|3 target controls covered
5%
O-RAN Alliance Security Specifications (O-RAN.WG11)
1 source controls mapped|1 target controls covered
5%
SEC Climate Disclosure Rule
1 source controls mapped|3 target controls covered
5%
SSAE 18 — Attestation Standards (SOC Reporting)
1 source controls mapped|1 target controls covered
5%
ECB TIBER-EU Framework
1 source controls mapped|1 target controls covered
5%
CISA Secure by Design Principles
1 source controls mapped|2 target controls covered
5%
Frequently Asked Questions
What is EU Medical Devices Regulation (MDR 2017/745)?
EU Medical Devices Regulation (MDR 2017/745) is a compliance framework from European Union with 4 domains and 20 controls. Regulation (EU) 2017/745 on medical devices replaces Directives 90/385/EEC and 93/42/EEC. It establishes a comprehensive regulatory framework for medical devices in the EU covering the entire product lifecycle from design and manufacturing through post-market surveillance. Applies to all medical devices placed on the EU market. Fully applicable since May 2021. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does EU Medical Devices Regulation (MDR 2017/745) have?
EU Medical Devices Regulation (MDR 2017/745) has 20 controls organised across 4 domains. The largest domains are Annex I — General Safety and Performance Requirements (6 controls), Chapter III — Economic Operators (5 controls), Chapter VII — Post-Market Surveillance (5 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does EU Medical Devices Regulation (MDR 2017/745) map to?
EU Medical Devices Regulation (MDR 2017/745) maps to 407 other compliance frameworks. The top mapping partners are ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence (40% coverage), NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements (40% coverage), ICH E6(R3) — Good Clinical Practice (40% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with EU Medical Devices Regulation (MDR 2017/745) compliance?
Start your EU Medical Devices Regulation (MDR 2017/745) 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 Medical Devices Regulation (MDR 2017/745) 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 20 controls and track your progress.
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