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).
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 23rd April 2020, the European Parliament adopted the regulation 2020/561 which amends the MDR including its date of application to 26 May 2021. This regulation did not affect the application of the IVDR 26 May 2022.
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.
For MDR, once the date of application is reached (26 May 2021), 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.
Class 1 devices as defined in the MDD with a declaration of conformity drawn up prior to 26 May 2021 and which had a certificate issued by a Notified Body in accordance with the MDD and AIMD can continue to be distributed in the market until 26 May 2024 if the product continues to comply with the directive and if there are no significant changed in the design and intended purpose.
Devices lawfully placed on the market prior to or on 26 May 2021 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).
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 (with a valid certificate) 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 February 2021, there are nineteen Notified Bodies with designation under the MDR and four under 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 has avoided potential market disruption and continues 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. The challenge is that the COVID-19 pandemic continues.