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
- Health and Food Safety (July 2024) – Q&A on implementation of Regulation (EU) 2023-607 – Extension of the MDR transitional period
- MDD 93/42/EEC – Obsoleted MDD
Relevant MDCG guidance documents
- Clinical Evaluation
- MDCG 2020-6 – Clinical evidence needed for medical devices previously CE marked under Directives 93-42-EEC or 90-385-EEC
- MDCG 2021-25 Rev1 – Requirements to ‘legacy devices’ and devices placed on the market prior to 26 May 2021 in accordance with Directives 90-385-EEC or 93-42-EEC
- MDCG 2021-24 – Classification of medical devices
- MDCG 2021-5 – Standardization for medical devices
- MDCG 2022-5 – Borderline between medical devices and medicinal products
- MDCG 2020-5 – Equivalence
- MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices
- MDCG 2018-2 – Medical device nomenclature description of requirements
- MDCG 2019-9 – Summary of Safety and Clinical Performance (SSCP)
- MDCG 2022-9 – Summary of Safety and Performance Template
- MDCG 2021-3 – Custom-made devices
- MDCG 2024-10 – Orphan medical devices
- MDCG 2022-18 – Application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
- MDCG 2022-18_add-1 – Addendum to MDCG 2022-18
- MDCG 2019-3 Rev1 – Interpretation of Article 54(2)b – Class IIb active devices intended to administer and/or remove a medicinal product
- Class I devices
- MDCG 2019-15 – Guidance notes for manufacturers of Class I medical devices
- Devices without medical purpose (Annex XVI)
- MDCG 2023-5 – Qualification and classification of Annex XVI products – Devices without medical purpose
- MDCG 2023-6 – Demonstration of equivalence for Annex XVI products – Devices without medical purpose
- Unique Device Identification (UDI)
- MDCG 2018-1 – Basic UDI-DI and changes to UDI-DI
- MDCG 2018-3 – UDI for systems and procedure packs
- MDCG 2018-5 – UDI for medical device software
- MDCG 2018-7 – Language issues associated with the UDI database
- MDCG 2019-1 – Entities rules on basic UDI-DI
- MDCG 2019-2 – Application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10)
- MDCG 2018-4 – Annex UDI database – Definitions Descriptions and formats of the UDI core elements for systems or procedure packs
- MDCG 2018-6 – Clarifications of UDI related responsibilities in relation to Article 16
- MDCG 2020-18 – UDI assignment for Spectacle lenses and Ready readers
- MDCG 2021-9 – Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses and Ready readers
- MDCG 2021-10 – The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
- MDCG 2021-19 – Integration of the UDI within an organization’s quality management system (QMS)
- MDCG 2022-7 – Unique Device Identification system
- MDCG 2024-14 – Implementation of the Master UDI-DI solution for contact lenses
- Post-Market Clinical Follow-up (PMCF)
- MDCG 2020-7 – Post-Market Clinical Follow-up (PMCF) Plan Template
- MDCG 2020-8 – Post-Market Clinical Follow-up (PMCF) Evaluation Report Template
- Clinical Investigations
- MDCG 2024-3 – Content of the Clinical Investigation Plan (CIP)
- MDCG 2024-5 – Content of the Investigator’s Brochure (IB)
- MDCG 2020-10 – Safety reporting
- MDCG 2021-20 – Instructions for generating Clinical Investigation ID (CIV-ID)
- MDCG 2021-8 – Clinical investigation application notification documents
- MDCG 2021-28 – Substantial modification of clinical Investigation
- MDCG 2023-7 – Exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6)
- MDCG 2024-15 – Publication of the clinical investigation reports and their summaries in the absence of EUDAMED
- MDCG 2021-6 – Q&A regarding clinical investigation
- Software as a Medical Device
- MDCG 2020-1 – Clinical evaluation of medical device software
- MDCG 2019-11 – Qualification and classification of software
- MDCG 2023-4 – Medical device software-hardware combinations
- MDCG 2019-16 – Cybersecurity
- MDCG 2025-4 – Safety of software apps and online platforms
- MDCG 2025-6 – Medical devices and artificial intelligence (AI)
- Post-Market Surveillance (PMS)
- MDCG 2022-21 – Periodic Safety Update Report (PSUR)
- MDCG 2023-3 – Vigilance terms and concepts
- European Database on Medical Devices (EUDAMED)
- MDCG 2019-4 – Timelines for registration of device data elements in EUDAMED
- MDCG 2019-5 – Registration of legacy devices in EUDAMED
- MDCG 2022-12 – Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional
- Labeling
- MDCG 2021-26 – Q&A on repackaging and relabeling activities under Article 16
- European Medical Device Nomenclature (EMDN)
- MDCG 2018-2 – Future EMDN description of requirements
- MDCG 2021-12 – FAQ on the EMDN
- MDCG 2024-2 – Procedures for the updates of the EMDN
- MDCG 2025-2 – Summary of EMDN 2024 Submissions and outcome of annual revision
- Implant Cards
- MDCG 2021-11 – Guidance on Implant Card – Device types
- MDCG 2019-8 – Application of Article 18
- In-house Devices
- MDCG 2023-1 – Health institution exemption under Article 5(5)
- Authorized Representatives, Importers, Distributors
- MDCG 2022-16 – Guidance on Authorised Representatives
- MDCG 2021-27 – Q&A on Articles 13 and 14
- Person Responsible for Regulatory Compliance (PRRC)
- MDCG 2019-07 – Guidance on article 15
- Post-Market Surveillance (PMS) and Vigilance (PMSV)
- MDCG 2022-1 – Guidance on Periodic Safety Update Report (PSUR)
- MDCG 2023-3 – Q&A on vigilance terms and concepts
- MDCG 2024-1 – Device Specific Vigilance Guidance (DSVG) Template
- MDCG 2024-1-1 – DSVG 01 on Cardiac ablation
- MDCG 2024-1-2 – DSVG 02 on Coronary stents
- MDCG 2024-1-3 – DSVG 03 on Cardiac implantable electronic devices (CIEDs)
- MDCG 2024-1-4 – DSVG 04 on Breast implants
- MDCG 2024-1-5 – DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence
- Notified Body
- MDCG 2021-23 – Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4)
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
- BSI – Clinical Evaluation Under EU MDR
- BSI – GSPRs – White paper
- BSI – GSPRs – Mapping guide
- BSI – Masterclass WET – Article 61(6) and MDCG 2020-6 (January 2022)
- BSI – MDR & IVDR Interpretation and Knowledge Support File Version 3 Rev B with TOC
- BSI – MDR FAQs
- BSI – AI Machine Learning and Medical Devices
- Other useful resources
- Health and Food Safety (September 2023) – Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR
- Borderline and Classification Working Group (September 2023) – Manual on borderline and classification under Regulations (EU) 2017-745 and 2017-746 v3
- Helsinki Procedure (June 2021) – Exchange of information between medical device competent authorities on borderline and classification cases
- EUDAMED Roll-out (November 2024) – Q&A on the gradual roll-out of EUDAMED
- Health and Food Safety (January 2020) – The Classificazione Nazionale Dispositivi Medici (CND) Nomenclature
- Health and Food Safety (January 2020) – The European Medical Device Nomenclature (EMDN)
- Software as a medical device – Infographic of device software
