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.
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:
- Publication of Commission Implementing Regulation (EU) 2023/2713 designating European Union reference laboratories in the field of in vitro diagnostic medical devices.
- Update of MDCG 2021-27 (Rev.1) Questions and Answers on Importers and Distributors (Articles 13 & 14).
September 2023:
- Update (v3) of Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746.
- Update (Rev.1) of MDCG 2020-3 Guidance 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.
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:
- Update of MDCG 2020-16 (Rev.2) - Guidance on Classification Rules for in vitro Diagnostic Medical Devices.
- Publication of MDCG 2023-3 - Questions and Answers on vigilance terms and concepts.
- European Parliament adopts Commission proposal (COM(2023)0010)
January 2023:
- Publication of MDCG 2023-2 – Template for List of Standard Fees.
- Publication of MDCG 2023-1 - Guidance on the health institution exception under Article 5(5).
- Publication of Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
- Press release - More time to certify medical devices to mitigate risks of shortages.
- Fact sheet: Supporting the transition to the new medical device framework.
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.
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:
- Publication of 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).
- Publication of Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746.
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.
April 2022:
- Publication of Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices.
February 2022:
- Publication of Update - MDCG 2021-21 Rev.1 - Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices.
- Publication of MDCG 2022-3 - Verification of manufactured class D IVDs by notified bodies.
- Publication of Updated - Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR.
December 2021:
- Publication of Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation.
- Publication of MDCG 2021-27 - Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
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:
- Notice to stakeholders: Status of EU-Switzerland mutual recognition agreement on medical devices.
- Press release 26 May 2021: announcing Stronger rules on medical devices (EU MDR) have entered into application.
- The UDI Helpdesk is live. Click here. The UDI Helpdesk is intended to help economic operators implement the requirements of the new UDI system.
- Publication of MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
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:
- Publication of an update of the ongoing guidance being developed by MDCG.
- Publication of an update on the Commission’s implementation rolling plan for the EU MDR and EU IVDR.
- Publication of MDCG 2020-17 Questions and Answers related to guidance on notified body audits during COVID-19 quarantine orders and travel restrictions.
October 2020:
- Publication of processes and procedures for using the EUDAMED (Actors) registration module from1 December 2020.
September 2020:
- Publication by the UK MHRA of new rules for regulating medical devices (including IVDs) from 1 January 2021 in Great Britain and Northern Ireland.
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:
- Publication of the European medical devices nomenclature necessary for EUDAMED as required by Article 23.
- The European Commission published MDCG 2019-16, Guidance on Cybersecurity for medical devices, including IVD medical devices.
December 2019:
- A second corrigendum to Regulation (EU) 2017/746 was published in the Official Journal of the European Union.
October 2019:
- The European Commission published the following statement about the launch of EUDAMED: “The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.” Click here to go to the Commission’s EUDAMED page.
- The European Commission published MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/746 – IVDR.
August 2019:
- The European Commission published a Frequently Asked Questions (FAQ) on the Unique Device Identification (UDI) System.
June 2019:
- The European Commission published MDCG 2019-7, guidance on the person responsible for regulatory compliance (PRRC).
- The European Commission published IMPLEMENTING DECISION (EU) 2019/939, designating four entities to assign Unique Device Identifiers (UDIs) to IVDs for the European market.
May 2019:
- Several technical EUDAMED documents were published including; a data dictionary, MDR and IVDR data sets, an update to the 2018-1 guidance on Basic UDI and changes, electronic data exchange introduction, definitions and guidelines.
- A Corrigendum (list of errors) to the EU IVDR was published in the Official Journal of the European Union of 5 May 2017. The errors identified are all minor: mainly single words, changed to enable greater consistency in interpretation, or corrections to errors in cross references within the regulation.
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:
- The EU Commission published the Functional specification for the EUDAMED database, including the project plan for implementation, as required by Article 34 of the Regulation.
November 2018:
- The EU Commission published updated versions of the Factsheet for Manufacturers of in vitro Diagnostic Medical Devices and the Implementation Model for the in vitro Diagnostic Medical Devices Regulation - Step by Step Guide.
- The EU Commission published three new Factsheets describing the implications of the new Regulations on various stakeholders: (1) Factsheet for Authorised Representatives, Importers and Distributors, (2) Factsheet for persons involved in the procurement medical devices and IVDs, (3) Factsheet for Authorities in non-EU/EEA States.
- The EU Commission published a new infographic illustrating the Transition Timelines from the Directives to the Regulations.
October 2018:
- The EU Commission published the terms of reference of 11 working groups established to support the MDCG by preparing guidance on; Notified body oversight, Standards, Clinical Investigation and Evaluation, Post-Market Surveillance and Vigilance, Market Surveillance, Borderline and Classification, New technologies, UDI, IVDs, International matters.
- The EU Commission published an updated state-of-play of joint assessments of Notified Bodies in the medical device sector.
- The EU Commission published its current MDR and IVDR implementing measures rolling plan, which includes the list of implementing acts to be published.
- Five new guidance and specification documents related to the new UDI system were published on the EU Commission site under MDCG Documents.
- The Agenda for the October meeting of the Medical Device Coordination Group was published.
September 2018:
- The Agenda for the September meeting of the Medical Device Coordination Group (MDCG) was published together with the Agenda for the meeting held between the MDCG and stakeholders, including industry representatives.
July 2018:
- Two new documents published by the EU Commission: A Fact sheet for Manufacturers of IVD medical devices, a Step by step implementation model and an Exhaustive list of requirements for manufacturers of medical devices.
- The Agenda for the July meeting of the Medical Device Coordination Group (MDCG) was published.
June 2018:
- The EU Commission published the state-of-play of joint assessments of Notified Bodies in the medical device sector.
May 2018:
- The Agenda and Minutes of the May meeting of the Medical Device Coordination Group (MDCG) were published.
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 <<<