EU Regulation and Guidance links
for medical devices and IVDs
In brief, here is a one stop site for all links related to European Invitro diagnostic and Medical Device European regulations and guidance. Because there is so much overlap between medicines, data protection, Ai this si a much asked for resource taht we now share online with our MedTech community.
Major Regulations
| Regulation | Link to full-text |
| Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (EU-MDR) | en Note: Translation of the Regulation in official languages available: MDR |
| Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (EU-IVDR) | en Note: Translation of the Regulation in official languages available: IVDR |
| Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTA) | en Note: Translation of the Regulation in official languages available: HTA |
| Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD) | en Note: Translation of the Regulation in official languages available: AIMDD |
| Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD) | en Note: Translation of the Regulation in official languages available: IVDD |
| Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD) | en Note: Translation of the Regulation in official languages available: MDD |
| Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use (CTR) | en Note: Translation of the Regulation in official languages available: CTR |
| Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use | en Note: Translation of the Regulation in official languages available: Medicines for Human Use |
| Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells | en Note: Translation of the Regulation in official languages available: Human tissues and cells |
| Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products | en Note: Translation of the Regulation in official languages available: Cosmetics |
| Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment (PPE) | en Note: Translation of the Regulation in official languages available PPE |
| Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) | en Note: Translation of the Regulation in official languages available > |
| European Association of Notified Bodies | https://www.team-nb.org/ |
EU current list of harmonised standards
| Reference | Title | Publication |
|---|---|---|
| (EU) 2021/1182 | Regulation (EU) 2017/745 on medical devices – Summary list of harmonised standards | Amendment of 6 March 2024 to Implementing Decision (EU) 2021/1182 |
Annex XVI products
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-6 | Guidance on demonstration of equivalence for Annex XVI products – A guide for manufacturers and notified bodies | December 2023 |
| MDCG 2023-5 | Guidance on qualification and classification of Annex XVI products – A guide for manufacturers and notified bodies | December 2023 |
| Q&A | September 2023 |
Borderline and Classification
| Reference | Title | Publication |
|---|---|---|
| Manual on Borderline | Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3 Background note on the use of the Manual on borderline and classification for medical devices under the Directives. | September 2023 |
| Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices | April 2022 | |
| Guidance on classification of medical devices | October 2021 | |
| Helsinki Procedure for borderline and classification under MDR & IVDR | September 2021 |
Class I Devices
| Reference | Title | Publication |
|---|---|---|
| MDCG 2020-2 rev.1 | Class I transitional provisions under Article 120 (3 and 4) – (MDR) | March 2020 |
| MDCG 2019-15 rev.1 | Guidance notes for manufacturers of class I medical devices | December 2019 |
Clinical investigation and evaluation
| Reference | Title | Publication |
|---|---|---|
Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices Clinical Investigation Plan Synopsis Template | March 2024 March 2024 | |
| Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence | December 2023 | |
| Commission Guidance on the content and structure of the summary of the clinical investigation report | May 2023 | |
| Substantial modification of clinical investigation under Medical Device Regulation | December 2021 | |
| Instructions for generating CIV-ID for MDR Clinical Investigations | July 2021 | |
| Clinical investigation application/notification documents | May 2021 | |
| Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation | December 2023 | |
| Clinical evaluation assessment report template | July 2020 | |
| MDCG 2020-10/1 Rev.1 | Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form | October 2022 October 2022 |
| MDCG 2020-8 | Guidance on PMCF evaluation report template | April 2020 |
| MDCG 2020-7 | Guidance on PMCF plan template | April 2020 |
| MDCG 2020-6 | Guidance on sufficient clinical evidence for legacy devices Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation | April 2020 |
| MDCG 2020-5 | Guidance on clinical evaluation – Equivalence | April 2020 |
| MDCG 2019-9 – Rev.1 | Summary of safety and clinical performance | March 2022 |
COVID-19
Custom-Made Devices
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-3 | Questions and Answers on Custom-Made Devices | March 2021 |
EUDAMED
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-12 | Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) | July 2022 |
| MDCG 2021-13 Rev. 1 | Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR | July 2021 |
| MDCG 2021-1 Rev. 1 | Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | May 2021 |
| MDCG 2020-15 | MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States | August 2020 |
| MDCG 2019-5 | Registration of legacy devices in EUDAMED | April 2019 |
| MDCG 2019-4 | Timelines for registration of device data elements in EUDAMED | April 2019 |
European Medical Device Nomenclature (EMDN)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2024-2 | Procedures for the updates of the EMDN | February 2024 |
| MDCG 2021-12 | FAQ on the European Medical Device Nomenclature (EMDN) | June 2021 |
| The EMDN – The nomenclature of use in EUDAMED | January 2020 | |
| The CND nomenclature – Background and general principles | January 2020 | |
| MDCG 2018-2 | Future EU medical device nomenclature – Description of requirements | March 2018 |
Implant cards
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-11 | Guidance on Implant Card – Device types | May 2021 |
| MDCG 2019-8 v2 | Guidance document implant card on the application of Article 18 Regulation (EU) 2017/745 on medical devices | March 2020 |
In-house devices
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-1 | Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | January 2023 |
Authorised Representatives, Importers, Distributors
| Reference | Title | Publication |
|---|---|---|
Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2022 | |
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | December 2023 | |
| MDCG 2021-26 | Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2021 |
In Vitro Diagnostic medical devices (IVD)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-20 | Substantial modification of performance study under Regulation (EU) 2017/746 | December 2022 |
| MDCG 2022-19 | Performance study application/notification documents under Regulation (EU) 2017/746 | December 2022 |
| MDCG 2022-15 | Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD | September 2022 |
| MDCG 2021-22 rev.1 | Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 | September 2022 |
| MDCG 2022-10 | Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) | May 2022 |
| MDCG 2022-9 | Summary of safety and performance template | May 2022 |
| MDCG 2022-8 | Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC | May 2022 |
| MDCG 2022-6 | Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR | May 2022 |
| MDCG 2022-3 | Verification of manufactured class D IVDs by notified bodies | February 2022 |
| MDCG 2022-2 | Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) | January 2022 |
| MDCG 2021-4 | Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 | April 2021 |
| MDCG 2020-16 Rev.2 | Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 | February 2023 |
New technologies
| Reference | Title | Publication |
|---|---|---|
| MDCG 2023-4 | Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components | October 2023 |
| Infographic | Is your software a Medical Device? | March 2021 |
| MDCG 2020-1 | Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software | March 2020 |
| MDCG 2019-16 rev.1 | Guidance on cybersecurity for medical devices | December 2019 |
| MDCG 2019-11 | Qualification and classification of software – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 | October 2019 |
Notified bodies
ReferenceTitlePublicationMDCG 2020-3 Rev.1Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
Note to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.
September 2023MDCG 2023-2
MDCG 2023-2 MDR form
MDCG 2023-2 IVDR formList of Standard FeesJanuary 2023MDCG 2022-4 rev.1Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDDDecember 2022MDCG 2022-17MDCG position paper on “hybrid audits”December 2022MDCG 2019-6 Rev.4Questions and answers: Requirements relating to notified bodiesOctober 2022MDCG 2022-13Designation, re-assessment and notification of conformity assessment bodies and notified bodiesAugust 2022MDCG 2021-23Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746August 2021MDCG 2021-18Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)July 2021MDCG 2021-17Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)July 2021MDCG 2021-16Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)July 2021MDCG 2021-15Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)July 2021MDCG 2021-14Explanatory note on IVDR codesJuly 2021MDCG 2020-17Questions and Answers related to MDCG 2020-4:
“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”December 2020MDCG 2020-14Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR)August 2020MDCG 2020-12Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissuesJune 2020MDCG 2020-11Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013May 2020MDCG 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020MDCG 2019-14Explanatory note on MDR codesDecember 2019MDCG 2019-13Guidance on sampling of devices for the assessment of the technical documentationDecember 2019MDCG 2019-12Designating authority’s final assessment form: Key information (EN)October 2019MDCG 2019-10 rev.1Application of transitional provisions concerning validity of certificates issued in accordance to the directivesOctober 2019MDCG 2018-8Guidance on content of the certificates, voluntary certificate transfersNovember 2018NBOG BPG 2017-2Best practice guidance on the information required for personnel involved in conformity assessmentFebruary 2018NBOG F 2017-8Review of qualification for the authorisation of personnel (IVDR)February 2018NBOG F 2017-7Review of qualification for the authorisation of personnel (MDR)February 2018NBOG F 2017-6Preliminary assessment review template (IVDR)February 2018NBOG F 2017-5Preliminary assessment review template (MDR)February 2018
Person responsible for regulatory compliance (PRRC)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2019-7 – Rev.1 | Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) | December 2023 |
Post-Market Surveillance and Vigilance (PMSV)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2024-1 | Device Specific Vigilance Guidance (DSVG) Template | January 2024 |
| MDCG 2024-1-1 | DSVG 01 on Cardiac ablation | January 2024 |
| MDCG 2024-1-2 | DSVG 02 on Coronary stents | January 2024 |
| MDCG 2024-1-3 | DSVG 03 on Cardiac implantable electronic devices (CIEDs) | January 2024 |
| MDCG 2024-1-4 | DSVG 04 on Breast implants | January 2024 |
| MDCG 2023-3 | Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices | February 2023 |
| MDCG 2022-21 | Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 | December 2022 |
Standards
| Reference | Title | Publication |
|---|---|---|
| MDCG 2021-5 | Guidance on standardisation for medical devices | April 2021 |
Unique Device Identifier (UDI)
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-7 | Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) | May 2022 |
| MDCG 2021-19 | Guidance note integration of the UDI within an organisation’s quality management system | July 2021 |
| MDCG 2021-10 | The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices | June 2021 |
| MDCG 2021-09 | MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers | May 2021 |
| MDCG 2018-1 Rev. 4 | Guidance on basic UDI-DI and changes to UDI-DI | April 2021 |
| MDCG 2020-18 | MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers | December 2020 |
| 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 | February 2019 |
| MDCG 2019-1 | MDCG guiding principles for issuing entities rules on basic UDI-DI | January 2019 |
| MDCG 2018-7 | Provisional considerations regarding language issues associated with the UDI database | October 2018 |
| MDCG 2018-6 | Clarifications of UDI related responsibilities in relation to article 16 | October 2018 |
| MDCG 2018-5 | UDI assignment to medical device software | October 2018 |
| MDCG 2018-4 | Definitions/descriptions and formats of the UDI core elements for systems or procedure packs | October 2018 |
| MDCG 2018-3 Rev.1 | Guidance on UDI for systems and procedure packs | June 2020 |
Other topics
| Reference | Title | Publication |
|---|---|---|
| MDCG 2022-11 – Rev.1 | MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements | November 2023 |
| Q&A Rev. 1 | Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods | July 2023 |
| MDCG 2022-18 ADD.1 | MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate – Addendum 1 | June 2023 |
| MDCG 2022-18 | MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate | December 2022 |
| MDCG 2022-14 | Transition to the MDR and IVDR – Notified body capacity and availability of medical devices and IVDs | August 2022 |
| MDCG 2021-25 | 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 | October 2021 |
| MDCG 2019-3 rev.1 | Clinical evaluation consultation procedure exemptions Interpretation of article 54(2)b | April 2020 |
Other guidance documents
| Reference | Title | Publication |
|---|---|---|
| MDR/IVDR Language requirements | Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country | January 2024 |
| European Medicines Agency (EMA) Guidance | Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) | June 2021 |
| SCHEER guidelines | Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties | June 2019 |
| CAMD FAQ | CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions | January 2018 |
