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 IVDR.


October 2024:

  • (New) First publication of MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices.

September 2024:

  • Update of MDCG 2021-4 rev.1 - Application of transitional provisions for certification of class D in vitro diagnostic medical devices.

July 2024:

  • Update of MDCG 2020-16 Rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
  • Update of MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices.

June 2024:

April 2024:

  • Publication of MDCG 2024-4 - Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746.
  • Update of MDCG 2022-9 (rev.1) - Summary of safety and performance template.

February 2024:

  • Publication of MDCG 2024-2 - Procedures for the updates of the EMDN.

January 2024:

  • Launch of a new dashboard to support the ongoing study into the availability of devices on the EU market.
  • Commission proposal to extend the transition periods for certain IVDs, the gradual roll-out of Eudamed and an information obligation in case of interruption of supply.
  • Publication of an overview of language requirements for manufacturers of medical devices and IVDs.

December 2023:

September 2023:

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 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746.
  • Publication of MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746.

November 2022:


October 2022:

  • Update of MDCG 2019-6 Rev 4 Questions and answers: Requirements relating to notified bodies.
  • Publication of MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

September 2022:

  • Publication of 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.
  • Publication of 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.

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.

July 2022:


May 2022:

  • Publication of Publication of Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for in vitro diagnostic medical devices.
  • Publication of 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).
  • .Publication of MDCG 2022-9 Summary of safety and performance template.
  • Publication of 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.
  • Publication of MDCG 2022-7 Q&A on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
  • Publication of MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.

October 2021:

  • Publication of MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16.
  • Publication of COM(2021)627 Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices.
  • Publication of Questions and Answers on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation.
  • Publication of Commission proposal for a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation.
  • 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).
  • Publication of MDCG 2021-22 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).

July 2021:

  • Publication of MDCG 2021-19 Integration of the UDI within an organisation’s quality management system.
  • Publication of MDCG 2021-14 Explanatory note on IVDR codes.
  • Publication of 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.

June 2021:

  • Publication of MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers.
  • Publication of infographic European Medical Device Nomenclature (EMDN) - Questions and Answers
  • Publication of MDCG 2021-12 FAQ on the European Medical Device Nomenclature (EMDN).
  • Publication of a Joint implementation and preparedness plan for the IVDR

May 2021:


April 2021:

  • 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.
  • Update to MDCG 2018-1 Rev 4 Guidance on basic UDI-DI and changes to UDI-DI.

March 2021:

  • 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:

  • Publication of a new MDCG position paper: MDCG 2020-15, on use of the EUDAMED actor registration module and Single Registration Number (SRN) in EU Member States.
  • Publication by the EU Commission of Unique Device Identification (UDI) System - FAQs.
  • Publication of new MDCG guidance for notified bodies: MDCG 2020-14, use of MDSAP audit reports in surveillance audits carried out under the MDR/IVDR.

May 2020:

  • 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 of a new MDCG guidance document MDCG 2020-1 on Clinical Evaluation / Performance Evaluation of Medical Device (including IVD) Software.

March 2020:

  • Publication of a new MDCG guidance document MDCG 2020-1 on Clinical Evaluation / Performance Evaluation of Medical Device (including IVD) Software.
  • Publication of a revision to the earlier MDCG guidance MDCG 2018-1 v3 on BASIC UDI-DI and changes to UDI-DI.

January 2020:


December 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 group # 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 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 Regulations are still under development however. >>> click here <<<