EU MDR and IVDR implementation and deadlines – Proposal for EU MDR application delay

The European Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) entered into force on 25 May 2017 replacing the Medical Device Directive (MDD), the Active Implantable Medical Device Directive (AIMD) and the In-Vitro Diagnostics Directive (IVDD). As indicated in the regulations, from the date the regulations entered into force, the MDR and IVDR will be applicable to medical devices in 2020 and 2022, respectively.

The impact that Covid-19 outbreak and the associated public health crisis has had on national authorities, health institutions, EU citizens, and economic operators,  led the European Commission to propose an amendment to the MDR 2017/745 to postpone its application date one year.  This proposal (2020/0060(COD)) was adopted on 3rd April 2020 and additionally, included the delay of the MDD 93/42/EEC and AIMD 90/385/EEC repeal for one year.

On 17th April 2020, the European Parliament voted to delay the application of the Regulation 2017/745 with the last step for the member states to vote on the proposal, which is expected to occur by 26 May 2020. This proposal will not affect the application of the IVDR.

Products compliant to and, as applicable, assessed to the regulation can be placed on the market prior to the regulation application date, however existing and unexpired EC certificates can transition as described below.

Critical Timing

For MDR, once the date of application is reached (26 May 2020 or 26 May 2021 as proposed), the EC certificates issued prior to 25 May 2017 will remain valid until they expire or until 27 May 2024 whichever comes first; except for certificates issued in accordance with Annex 4 of AIMD or Annex IV of MDD which will be void on 27 May 2022. Devices lawfully placed on the market prior to or on 26 May 2020 (or 26 May 2021 as proposed) and in accordance with the MDD or AIMD may continue to be made available on the market or put into service until 26 May 2025 (except those issued in accordance with Annex 4 of AIMD or Annex IV of MDD). Products already legally marketed in accordance with the AIMD and/or MDD or those in compliance with Annex 4/IV must continue to comply with the respective Directive with no significant changes in the design and intended purpose.

For the IVDR, once the date of application is reached (26 May 2022), the EC certificates issued prior to 25 May 2017 will remain valid until they expire or until 27 May 2024 whichever comes first; except for certificates issued in accordance with Annex VI which will become void on 27 May 2024. Devices lawfully placed on the market prior to or on 26 May 2022 and in accordance with the IVDD, may continue to be made available on the market or put into service until 27 May 2025 (except those issued in accordance with Annex VI of IVDD). Products already legally marketed in accordance with the IVDD or those in compliance with Annex VI must continue to comply with the respective Directive with no significant changes in the design and intended purpose.

Scope of Impact

The laws impact Medical Device Manufacturers, Distributors, Importers, Notified Bodies, Authorized Representatives, the Member States, and the European Commission. Due to their broad impact, stakeholders must plan and prepare for the required changes now. As of April 2020, a limited number of Notified Bodies have obtained designation under the MDR and IVDR.

This law is very complex and with new requirements. Its implementation requires strategic planning based on a detailed analysis of the requirements. The new requirements and the amount of pre- and post-market evidence needed to demonstrate medical device safety and performance have increased. To some devices, especially IIb and those reclassified to a higher risk classification, the changes are significant as the requirements continue to be commensurate with the risk of the device. As such, business decisions may need to be made redefining product lines and target markets prior to plan execution. Due to the nature of the regulation changes it should be expected that the product requirements will differ by product line. Additionally, this regulation impacts aspects of the Quality System.

Many in the medical device industry continue their due diligence work and certification process under the MDR per their implementation plans. Companies that could recertify products under the Directives have pursued it. The delay on the application date of the MDR will avoid potential market disruption and continue supply of medical devices vitally important to manage the unanticipated impact that the COVID 19 outbreak and health crisis have caused on Member States, national authorities, health institutions, EU citizens, and economic operators.

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