EU Medical Devices Regulation (MDR 2017/745)
Regulation (EU) 2017/745 (the MDR) is the EU horizontal regime for medical devices and accessories, replacing the prior MDD (93/42/EEC) and AIMDD (90/385/EEC) framework. It applied from 26 May 2021. Regulation (EU) 2023/607 extended transitional periods for legacy MDs (under MDD/AIMDD certificates) by risk class: Class III implantables + Class IIb implantables (with exceptions) until 31 December 2027; other Class IIb + Class IIa + Class I (sterile/measuring) until 31 December 2028; legacy Class I (with NB involvement under MDD Annex II/V) until same dates. Key levers: Article 5 placing on market gating + Article 7 prohibition of misleading claims; Articles 10-15 manufacturer + authorised representative + importer + distributor + Person Responsible for Regulatory Compliance (PRRC) obligations; Article 16 substantial-modification rule; Articles 17-23 single-use device reprocessing + implant card + EU declaration of conformity + CE marking + special-purpose devices + systems/procedure packs; Article 25 supply-chain identification; Articles 27-30 UDI system + UDI database + device registration; Article 31 economic-operator registration; Article 32 summary of safety and clinical performance (SSCP, public via EUDAMED); Article 33 EUDAMED. Article 51 risk classification (Class I/IIa/IIb/III). Articles 52-60 conformity assessment + Article 54 consultation procedure for certain Class III/IIb + Article 55 scrutiny mechanism for certain Class III/IIb. Articles 61-82 clinical evaluation + clinical investigations including informed consent + vulnerable subject protection + adverse-event recording. Articles 83-90 post-market surveillance + Periodic Safety Update Report (PSUR) + serious-incident reporting + Field Safety Corrective Actions (FSCAs) + trend reporting. Article 109 confidentiality + Article 110-111 data protection. Article 116 civil-liability financial-coverage requirement. Article 120 transitional provisions (as amended by 2023/607).
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Framework Domains (7)
MDR - Classification + Conformity Assessment (Ch V)
| Code | Title |
|---|---|
| MDR-Art.51 | Classification of devices (Article 51 and Annex VIII) |
| MDR-Art.52_54_55 | Conformity assessment, consultation procedure and scrutiny mechanism (Articles 52, 54, 55) |
| MDR-Art.56_57 | Certificates of conformity and electronic system (Articles 56-57) |
MDR - Clinical Evaluation + Clinical Investigations (Ch VI)
| Code | Title |
|---|---|
| MDR-Art.61_62 | Clinical evaluation and clinical investigations general requirements (Articles 61-62) |
| MDR-Art.70_74_75_80_82 | Clinical-investigation application + CE-marked-device studies + substantial modifications + adverse events + records (Articles 70, 74-75, 80, 82) |
MDR - Identification, UDI, Registration and EUDAMED (Ch III)
| Code | Title |
|---|---|
| MDR-Art.19_20 | EU declaration of conformity and CE marking (Articles 19-20) |
| MDR-Art.21_22_23 | Special purposes, systems and procedure packs, parts and components (Articles 21-23) |
| MDR-Art.25_27_28 | Supply-chain identification and UDI system (Articles 25, 27-28) |
| MDR-Art.29_30_31 | Registration of devices and economic operators (Articles 29-31) |
| MDR-Art.32_33 | Summary of Safety and Clinical Performance + EUDAMED (Articles 32-33) |
MDR - Making Available + Economic Operators (Ch II)
| Code | Title |
|---|---|
| MDR-Art.10 | General obligations of manufacturers (Article 10) |
| MDR-Art.11_12_13_14 | Authorised representative, importers and distributors (Articles 11-14) |
| MDR-Art.15 | Person Responsible for Regulatory Compliance (Article 15) |
| MDR-Art.16 | Cases where manufacturer obligations apply to others (Article 16) |
| MDR-Art.17_18 | Single-use device reprocessing and implant card (Articles 17-18) |
| MDR-Art.5_6_7 | Placing on market + distance sales + misleading claims (Articles 5-7) |
MDR - Notified Bodies (Ch IV)
| Code | Title |
|---|---|
| MDR-Art.35_36_37_38_39_40_41_42_45_46_47_50 | Notified bodies - authorities, requirements, subsidiaries, designations and re-assessment (Articles 35-50 selected) |
MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X)
| Code | Title |
|---|---|
| MDR-Art.103_104_105_106_107_108 | Medical Device Coordination Group + EU expert panels + EU reference laboratories (Articles 103-108) |
| MDR-Art.109_110_111_112_113_115 | Confidentiality, data protection, funding, civil liability and penalties (Articles 109-115) |
| MDR-Art.120 | Transitional provisions (Article 120 as amended by (EU) 2023/607) |
| MDR-Art.122_123 | Entry into force and date of application (Articles 122-123) |
| MDR-Art.83 | Post-market surveillance system of the manufacturer (Article 83) |
| MDR-Art.84_85_86 | PMS plan + PMS report + Periodic Safety Update Report (Articles 84-86) |
| MDR-Art.87_88_89_90_91_92 | Vigilance + serious incident reporting + FSCAs + trend reporting (Articles 87-92) |
| MDR-Art.93_94_95_96_97_98 | Market surveillance + Member-State competent authorities (Articles 93-98) |
MDR - Scope, Definitions and General Provisions (Ch I)
| Code | Title |
|---|---|
| MDR-Art.1_2_3_4 | Subject matter, scope, definitions and regulatory status (Articles 1-4) |
Your Compliance Coverage
If you comply with EU Medical Devices Regulation (MDR 2017/745), you already cover:
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
42%
11 controls mapped
Compare →FDA Quality Management System Regulation (QMSR)
12%
3 controls mapped
Compare →GDPR
8%
2 controls mapped
Compare →+ 2 more: EU Clinical Trials Regulation (CTR 536/2014) (8%), EU Cyber Resilience Act (4%)
See all 5 mapped frameworks ↓Maps to 5 other frameworks
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 7 domains and 26 controls. Regulation (EU) 2017/745 (the MDR) is the EU horizontal regime for medical devices and accessories, replacing the prior MDD (93/42/EEC) and AIMDD (90/385/EEC) framework. It applied from 26 May 2021. Regulation (EU) 2023/607 extended transitional periods for legacy MDs (under MDD/AIMDD certificates) by risk class: Class III implantables + Class IIb implantables (with exceptions) until 31 December 2027; other Class IIb + Class IIa + Class I (sterile/measuring) until 31 December 2028; legacy Class I (with NB involvement under MDD Annex II/V) until same dates. Key levers: Article 5 placing on market gating + Article 7 prohibition of misleading claims; Articles 10-15 manufacturer + authorised representative + importer + distributor + Person Responsible for Regulatory Compliance (PRRC) obligations; Article 16 substantial-modification rule; Articles 17-23 single-use device reprocessing + implant card + EU declaration of conformity + CE marking + special-purpose devices + systems/procedure packs; Article 25 supply-chain identification; Articles 27-30 UDI system + UDI database + device registration; Article 31 economic-operator registration; Article 32 summary of safety and clinical performance (SSCP, public via EUDAMED); Article 33 EUDAMED. Article 51 risk classification (Class I/IIa/IIb/III). Articles 52-60 conformity assessment + Article 54 consultation procedure for certain Class III/IIb + Article 55 scrutiny mechanism for certain Class III/IIb. Articles 61-82 clinical evaluation + clinical investigations including informed consent + vulnerable subject protection + adverse-event recording. Articles 83-90 post-market surveillance + Periodic Safety Update Report (PSUR) + serious-incident reporting + Field Safety Corrective Actions (FSCAs) + trend reporting. Article 109 confidentiality + Article 110-111 data protection. Article 116 civil-liability financial-coverage requirement. Article 120 transitional provisions (as amended by 2023/607). 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 26 controls organised across 7 domains. The largest domains are MDR - PMS + Vigilance + Market Surveillance + Final (Ch VII-X) (8 controls), MDR - Making Available + Economic Operators (Ch II) (6 controls), MDR - Identification, UDI, Registration and EUDAMED (Ch III) (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 5 other compliance frameworks. The top mapping partners are EU In Vitro Diagnostic Medical Devices Regulation (IVDR) (42% coverage), FDA Quality Management System Regulation (QMSR) (12% coverage), GDPR (8% 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?
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