The European Union (EU) Medical Device Regulation (MDR) 2017/745 was introduced in 2017 to replace the Medical Device Directive (MDD) 93/42/EEC (as an amendment to 90/358/EEC, with the latest amendment in 2010 by 2007/47/EC). Since it became effective on 26 May 2017, the transition period from MDD 93/42/EEC to compliance with the EU MDR 2017/745 has been extended twice, to now come into full effect on 31 December 2027 for Class III devices, and 31 December 2028 for Class IIb, IIa, and I devices per EU MDR 2023/607.
Whereas the MDD was merely a recommendation for manufacturers of medical devices to conduct proper (clinical) tests prior to placing a medical device on the EU market, the MDR is law. The latter means that manufacturers must now adhere to much more stringent regulations in order to bring new medical devices onto the EU market, but also to retain their medical devices that had previously been placed on the EU market under the MDD.
The EU MDR 2017/745 mandates manufacturers to extensively evaluate the clinical safety and performance of the medical device to ensure that it is safe to both the patient and the user, and that the benefits of using the device for its intended purpose outweigh the potential risks, as summarized in the General Safety and Performance Requirements (GSPRs). These clinical evaluations are to be strategized in a Clinical Evaluation Plan (CEP) and the results, findings and conclusions are to be documented in a Clinical Evaluation Report (CER), which are to be submitted to the Notified Body (NB) for scrutinization. If approved, the medical device will receive a CE mark, which allows it to be placed and sold on the EU market.
However, since the EU MDR 2017/745 was written by lawmakers, it is rather difficult to understand and apply the content from a practical perspective, and what it all means for manufacturers. To that end, the Medical Device Coordination Group (MDCG) was brought into existence, which has published numerous guidance documents to help manufacturers interpret all aspects of the EU MDR 2017/745.
Below are PDFs of the original EU MDR 2017/745 and two subsequent amendments that extended the implementation deadline, as well as the obsoleted MDD 93/42/EEC, and the applicable MDCG guidance documents.
EU MDR documents
- EU MDR 2023/607 – Extension to 2027 and beyond
- EU MDR 2020/561 – Extension to 2021
- EU MDR 2017/745 – Original EU MDR, replacing the MDD
- MDD 93/42/EEC – Obsoleted MDD
Relevant MDCG guidance documents
- MDCG 2018-1 – Guidance on BASIC UDI-DI and changes to UDI-DI
- MDCG 2018-2 – Global Medical Device Nomenclature System
- MDCG 2018-3 – Guidance on UDI for systems and procedure packs
- MDCG 2018-4 – Annex UDI database – Definitions Descriptions and formats of the UDI core elements for systems or procedure packs
- MDCG 2018-5 – UDI Assignment to Medical Device Software
- MDCG 2018-6 – Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017-745 and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017-746
- MDCG 2019-2 – Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745-2017
- MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED
- MDCG 2019-5 – Registration of legacy devices in EUDAMED
- MDCG 2019-9 – Summary of safety and clinical performance
- MDCG 2019-11 – Guidance on Qualification and Classification of Software in Regulation (EU) 2017-745 – MDR and Regulation (EU) 2017-746 – IVDR
- MDCG 2019-15 – Guidance notes for manufacturers of Class I medical devices
- MDCG 2019-16 – Guidance on Cybersecurity for medical devices
- MDCG 2020-1 – Guidance on Clinical Evaluation (MDR) – Performance Evaluation (IVDR) of Medical Device Software
- MDCG 2020-5 – Clinical Evaluation – Equivalence
- MDCG 2020-6 – Regulation (EU) 2017-745 – Clinical evidence needed for medical devices previously CE marked under Directives 93-42-EEC or 90-385-EEC
- MDCG 2020-7 – Post-market clinical follow-up (PMCF) Plan Template
- MDCG 2020-8 – Post-market clinical follow-up (PMCF) Evaluation Report Template
- MDCG 2021-3 – Questions and Answers on Custom-Made Devices
- MDCG 2021-5 – Guidance on standardisation for medical devices
- MDCG 2021-6 – Regulation (EU) 2017-745 – Questions and Answers regarding clinical investigation
- MDCG 2021-19 – Guidance note integration of the UDI within an organisation’s quality management system
- MDCG 2021-20 – Instructions for generating CIV-ID for MDR Clinical Investigations
- MDCG 2021-23 – Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017-745 and Regulation (EU) 2017-746
- MDCG 2021-24 – Guidance on classification of medical devices
- MDCG 2021-25 – Regulation (EU) 2017-745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90-385-EEC or 93-42-EEC
- MDCG 2021-26 – Questions and Answers on repackaging and relabelling activities under Article 16 of Regulation (EU) 2017-745 and Regulation (EU) 2017-746
- MDCG 2021-28 – Substantial modification of clinical Investigation under Medical Device Regulation
- MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
Other guidance documents
- MEDDEV – Clinical documentation
- MEDDEV 2.7/1 Rev. 4 – Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC
- MEDDEV 2.12/2 Rev. 2 – Post Market Clinical Follow-Up Studies: A Guide for Manufacturers and Notified Bodies
- OCEBM – Literature assessment
- OCEBM 2011-Introducton – Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence: Introduction
- OCEBM 2011-Background – Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence: Background
- OCEBM 2011-Summary – Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence: Summary
- GHTF – Clinical documentation
- GHTF SG5-N2R8 2007 – Global Harmonization Task Force – Clinical Evaluation
- IMDRF – Clinical documentation
- IMDRF MDCE WG-N55 FINAL 2019 – International Medical Device Regulators Forum – Clinical Evidence
- IMDRF MDCE WG-N56 FINAL 2019 – International Medical Device Regulators Forum – Clinical Evaluation
- IMDRF MDCE WG-N57 FINAL 2019 – International Medical Device Regulators Forum – Clinical Investigation
- Notified Body – EU MDR 2017/745 compliance
- BSI Master Class July 2023 – Best Practice Guidance for the Submission of Clinical Evaluation Documentation for Conformity Assessment by the Notified Body
