Click the link below to view the latest information from the European Commission on the medical devices sector.

Listed below are some of the most recent publications supporting the implementation of the EU MDR.


December 2023:

  • Publication of MDCG 2023-7 guidance on exemptions from the requirements to perform clinical investigations.
  • Update of MDCG 2021-6 (Rev.1) Questions & Answers regarding clinical investigations.
  • Update of MDCG 2021-27 (Rev.1) Questions and Answers on Importers and Distributors (Articles 13 & 14).
  • Publication of MDCG 2023-5 Guidance on qualification and classification of Annex XVI products (without an intended medical purpose).
  • Publication of MDCG 2023-6, Guidance on demonstration of equivalence for Annex XVI products (without an intended medical purpose).

November 2023:

  • Update to MDCG 2022-11 (Rev 1) Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements.

October 2023:

  • Publication of MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components.

September 2023:


May 2023:

  • Publication of 2023/C 163/06 Commission Guidance on the content and structure of the summary of the clinical investigation report.
  • Publication of MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR.

March 2023:

  • Publication of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
  • Publication of a Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

February 2023:


December 2022:

  • Publication of MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745.
  • Update of Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 (v2)
  • Update of MDCG 2022-4 Rev 1 Guidance 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 AIMDD.
  • Publication of MCDG 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.
  • Publication of Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745.
  • Publication of Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745.

October 2022:

  • Update of MDCG 2019-6 Rev 4 Questions and answers: Requirements relating to notified bodies.
  • Update of MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 and Appendix: Clinical investigation summary safety report form.
  • Publication of MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

September 2022:


August 2022:

  • Publication of MDCG 2022-14 Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs.
  • Publication of MDCG 2022-13 Designation, re-assessment and notification of conformity assessment bodies and notified bodies.

June 2022:

  • Publication of MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements.

May 2022:

  • Publication of MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU).

April 2022:


March 2022:

  • Publication of (revision) MDCG 2019-9 Rev.1 Summary of safety and clinical performance. A guide for manufacturers and notified bodies.

February 2022:

  • Publication of MDCG 2022-4 Guidance 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 AIMDD.

December 2021:

  • Publication of (EU) 2021/2226 Commission Implementing Regulation (EU) 2021/2226 on electronic instructions for use of medical devices.
  • Publication of MDCG 2021-28 Substantial modification of a clinical investigation.
  • Publication of MDCG 2021-27 Questions and Answers on Articles 13 & 14 (importers and distributors).

November 2021:

  • Publication of (EU) 2021/2078 Commission Implementing Regulation on the European Database on Medical Devices (Eudamed).

October 2021:

  • Publication of MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16.
  • Publication of MDCG 2021-25 Application of MDR requirements to ‘legacy devices’ and devices placed on the market prior to 26 May 2021.
  • Publication of MDCG 2021-24 Guidance on classification of medical devices.
  • The EUDAMED UDI/Devices and NBs & Certificates modules are now open for economic operators and notified bodies.

August 2021:

  • Publication of MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4).

July 2021:


June 2021:


May 2021:


April 2021:

  • Publication of MDCG 2021-6 Questions & Answers regarding clinical investigation.
  • Publication of MDCG 2021-5 Guidance on standardisation for medical devices.
  • Publication of MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices (according to Regulation (EU) 2017/746).
  • Update to (revision) MDCG 2018-1 Rev 4 Guidance on basic UDI-DI and changes to UDI-DI.
  • Publication of a Factsheet on Class 1 Medical Devices.

March 2021:

  • Publication of MDCG 2021-3 Questions and Answers on Custom-Made Devices.
  • Publication of MDCG 2021-2 Guidance on state of the art of COVID-19 rapid antibody tests.
  • Publication of an Infographic "Is your software a Medical Device?"

February 2021:

  • Publication of MDCG 2021-1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional.

December 2020:


November 2020:

  • Publication of MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

October 2020:


September 2020:


August 2020:


July 2020:

  • Publication of new MDCG guidance for notified bodies: MDCG 2020-13, template for the assessment report of the manufacturer’s clinical evaluation.

June 2020:

  • Publication of new MDCG guidance for notified bodies: MDCG 2020-12, transitional (MDD/AIMD to MDR) arrangements for consultations with medicines authorities.

May 2020:

  • Publication of an update to the 2020 Manufacturer’s Incident Report (MIR) form, new version 7.2.1 together with a Questions and Answers document on implementation.
  • Publication a new MDCG guidance: MDCG 2020-10/1 on Safety reporting in clinical investigations together with MDCG 2020-10/2 the Clinical Investigation Summary Safety Report Form.

April 2020: Publication in the Official Journal of the European Union of Regulation (EU) 2020/561 amending the date of application of Regulation (EU) 2017/745 from 26 May 2020 to 26 May 2021.


April 2020:

  • Publication of two new MDCG guidance documents: MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template and MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template.
  • Publication of two new MDCG guidance documents: MDCG 2020-5 on Clinical Evaluation – Equivalence and MDCG 2020-6 on Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC.

March 2020:

  • The Commission announced on 25 March 2020 a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year.
  • Publication of three new MDCG guidance documents: MDCG 2020-1 on Clinical Evaluation / Performance Evaluation of Medical Device Software, MDCG 2020-2 Class I Transitional provisions, MDCG 2020-3 on significant changes under Article 120.
  • Publication of revisions to two earlier MDCG guidance documents: MDCG 2018-1 v3 on BASIC UDI-DI and changes to UDI-DI and MDCG 2019-8 v2 on Implant cards.
  • Publication of joint Commission and Member States priorities and actions to be completed prior to May 2020.

January 2020:


December 2019: 


November 2019:


October 2019:


June 2019:


May 2019:


April 2019:

The Medical Device Coordination Group (MDCG) approved two further documents clarifying the timelines and requirements for using the EUDAMED database:

  • Document 2019-4 confirms the deadline for registering device details in EUDAMED (Annex VI Part A, section 2, and Part B) will be either; (a) 18 months after the May 2020 application date, if EUDAMED is already deemed (by independent audit) to be fully functional in time. Or (b) 24 months after the date when EUDAMED is deemed to be fully functional.
  • Document 2019-5 confirms that so called legacy devices (marketed after May 2020 on the basis of an MDD certificate) will not require either a basic UDI-DI or a UDI-DI for registration.

March 2019:


November 2018:


October 2018:


September 2018:


July 2018:


May 2018:


April 2018:

  • Following endorsement by the MDCG in March, the first new documents related to the European UDI have been published; two guidance documents and two definition documents.  They have been published on the Commission’s medical device guidance page, in a new sub-section titled “MDCG documents”.

March 2018:

  • The Medical Device Coordination Group (MDCG) met for their second meeting. Although the meetings themselves are not open to the public, the agenda and minutes are publicly available.
  • The European Committee for Standardization (CEN) published CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and the European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation.

February 2018:

  • Publication of the agenda and minutes of the initial meeting of Medical Device Coordination Group (MDCG), which took place in November 2017. Topics on the agenda included the current state of play of Eudamed, UDI and the implementing Acts.

January 2018:

  • The EU Competent Authorities for Medical Devices (CAMD) have also published FAQs specifically on the transitional arrangements: MDD to MDR and IVDD to IVDR.
  • The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. It is listed in the register of Commission expert groups as # X03565. Its mission includes “ensuring a harmonized implementation” of the new Regulations.  >>> click here <<<
  • The EU Commission has published a “Notice to Stakeholders” about the implications of the UK’s withdrawal from the EU which makes matters completely clear. As the Notice says: “all Union primary and secondary law will cease to apply to the United Kingdom from 30 March 2019, 00:00h (CET) ('the withdrawal date'). The United Kingdom will then become a 'third country'.” This means, unless a special deal is struck between the UK and the EU before 30th March 2019, a UK based company cannot act as a Notified Body, Authorized Representative or Importer under the new Regulation (or under the current Directive).  >>> click here <<<

November 2017:

  • The EU Competent Authorities for Medical Devices (CAMD) published the first publicly seen version of a “road map” for the development of the detailed regulatory guidance documents needed to support the implementation of the EU MDR and EU IVDR. While this first version road map doesn’t contain timelines, it does indicate the priority being given to the respective documents. >>> click here <<<
  • The European Commission published the first Implementing Regulation related to the EU MDR and EU IVDR in the Official Journal of the EU. Regulation (EU) 2017/2185 contains the codes and corresponding types of devices to be used to specify the scope of the designations of Notified Bodies. >>> click here <<<
  • The Notified Body Operations Group (NBOG) published several new documents related to the EU MDR and EU IVDR on their website. They include a best practice guide to the (re-)designation and notification process and the addition forms to be submitted by an applicant Notified Body. >>> click here <<<

October 2017:

  • As Switzerland is not an EU or EEA member state, the new EU Regulations are not law there. In October 2017 the Swiss parliament passed an interim act (Medizinprodukteverordnung (MepV)) that enables candidate Notified Bodies based in Switzerland to apply to Swissmedic for designation according to the new EU Regulations. It also allows Swissmedic to appoint experts to the new EU Medical Device Coordination Group (MDGC). The Swiss versions of the new EU MDR and IVDR Regulations are still under development however. >>> click here <<<