Here you can read about some of the most recent developments related to implementation.
August 2020: 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.
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.
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.
January 2020: The European Commission published MDCG 2019-16: Guidance on Cybersecurity for medical devices.
December 2019: A second corrigendum to Regulation (EU) 2017/745 was published in the Official Journal of the European Union. Probably the most significant change being the extension of the transitional provisions in Article 120(3) to include legacy (MDD) Class 1 devices which require a notified body certificate under the EU MDR.
December 2019: The European Commission published MDCG 2019-15: Guidance notes for manufacturers of Class I medical devices.
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.”
October 2019: The European Commission published MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR.
August 2019: The European Commission published MDCG 2019-9, A guide for manufacturers and notified bodies to the Summary of safety and clinical performance (SSCP).
June 2019: The European Commission published MDCG 2019-8, guidance on the format of the implant card to be provided to patients.
June 2019: The European Commission published MDCG 2019-7, guidance on the person responsible for regulatory compliance (PRRC).
June 2019: The European Medicines Agency (EMA) published a draft guideline and commenced consultations on the implementation of EU MDR Article 117 related to drug-device combinations.
May 2019: A Corrigendum (list of errors) to the EU MDR 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 its Factsheet for Manufacturers of Medical Devices and Implementation Model for the Medical Devices Regulation - Step by Step Guide.
November 2018: 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.
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.
October 2018: The EU Commission published an updated state-of-play of joint assessments of Notified Bodies in the medical device sector.
October 2018: The EU Commission published its current MDR and IVDR implementing measures rolling plan, which includes the list of implementing acts to be published.
October 2018: Five new guidance and specification documents related to the new UDI system were published on the EU Commission site under MDCG Documents.
October 2018: 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: Three new documents published by the EU Commission: A Fact sheet for Manufacturers of medical devices and a Step by step implementation model and an Exhaustive list of requirements for manufacturers of medical devices.
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 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.
March 2018: 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 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 <<<
January 2018: For those uncertain about the implications of “Brexit” and wondering whether they can still use a Notified Body, Authorized Representative or Importer in the UK. 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 <<<
November 2017: 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 <<<
November 2017: 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 <<<