European Commission Publishes MDR and IVDR Factsheet for Non-EU/EEA Countries
Authored by Elizabeth Anne Wright, Partner, Cooley LLP, Jessica Lauren Koffel, Associate, Cooley LLP, & Alix vermulst, Cooley LLP
On 12 July 2023, the European Commission published a factsheet for authorities outside the European Union (EU) and the European Economic Area (EEA) on the implications of the extended deadlines in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). On 15 March 2023, the MDR and IVDR were amended with deadlines extended beyond the originally established date of 26 May 2024. Consequently, devices that continue to be compliant with the regime provided in the Medical Devices Directive (MDD) may still enter the EEA market beyond the date of entry into application of the MDR/IVDR. The factsheet provides clarification of the transitional phases for regulatory authorities in countries outside the EU/EEA, and it includes diagrams setting out the extended deadlines for transitioning and the conditions attached to benefit from these extensions.
Medical Devices CE marked on Basis of Directives
During the transition period, devices which were CE marked on the basis of the MDD, the Active Implantable Medical Devices Directive (AIMDD) and the In Vitro Diagnostic Devices Directive (IVDD) still may be placed on the market in the EEA beyond the official date of application for the MDR (26 May 2021) and the IVDR (26 May 2022). This means that devices CE marked on the basis of the directives may continue to be available on the territory of third countries.
Implications of Revised MDR
In the factsheet, the European Commission notes that:
- Medical devices that do not, on the basis of the MDR, require involvement of a notified body in their conformity assessment, such as Class I medical devices and most custom-made devices, must have been demonstrated to comply with the MDR from 26 May 2021, as the revised transition provisions do not apply to these devices.
- New medical devices not previously covered by a CE certificate of conformity or declaration of conformity issued under the MDD/AIMDD must be demonstrated to comply with the MDR since 26 May 2021, as the revised transition provisions do not apply to these devices.
- Medical devices that did not require the involvement of a notified body on the basis of the MDD/AIMDD – but do so on the basis of the MDR and for which the manufacturer prepared a declaration of conformity before 26 May 2021 – may continue to be placed on the EEA market until 31 December 2028.
- Medical devices covered by CE certificates of conformity issued by a notified body on the basis of the MDD/AIMDD between 25 May 2017 and 26 May 2021 that remain valid on 26 May 2021 may be placed on the EEA market until 31 December 2027 or 31 December 2028 at the latest, depending on the risk class of the device.
- CE certificates of conformity issued by notified bodies remain valid until either 31 December 2027 or 31 December 2028, unless the certificate is withdrawn sooner by the notified body.
To benefit from the extended deadlines for which the revisions to the MDR and IVDR provide, manufacturers must apply to a notified body for a conformity assessment before 26 May 2024. In addition, manufacturers must sign an agreement with the notified body in relation to conduct of the conformity assessment by 26 September 2024. Manufacturers may use a self-declaration as evidence of the application and agreement related to the conformity assessment process, and this may be supported by a confirmation letter from the notified body. However, manufacturers also may provide such evidence through other means. There must be no significant changes in the design or intended purpose of medical devices benefitting from the extended deadlines.
Implications of Revised IVDR
In the factsheet, the European Commission notes that:
- For IVDs that do not require the involvement of a notified body for a conformity assessment on the basis of the IVDR, such as Class A non-sterile IVDs, compliance with the IVDR has been required since 26 May 2022, and the revised transition provisions do not apply to these devices.
- New IVDs not previously covered by a CE certificate of conformity issued by a notified body on the basis of the IVDD or a declaration of conformity prepared on the basis of the IVDD also must already be demonstrated to comply with the IVDR since 26 May 2022, so the revised transition provisions do not apply to these devices.
- CE certificates of conformity issued by a notified body on the basis of the IVDD after 25 May 2017 or in accordance with Annex VI to the IVDD before 25 May 2017, and IVDs covered by such CE certificates of conformity, remain valid until the sooner of the end of the period on the certificate or 27 May 2025.
- IVDs in relation to which the involvement of a notified body in a conformity assessment based on the IVDD was unnecessary – but in relation to which notified body intervention will be required on the basis of the IVDR, and for which the manufacturer has drawn up a declaration of conformity before 26 May 2022 – may continue to be placed on the EEA market until the end of a specified transition period, based on the risk class of the IVD.
To benefit from the extended deadlines, there must be no significant changes in the design or intended purpose of the IVD.
This commentary is brought to you by Cooley, one of the world’s leading law firms for innovative companies. Cooley has built a global team of specialist products lawyers, led by some of the leading and best-recognized practitioners, who are able to provide strategic advice and practical solutions to global product safety and compliance issues. With access to an extensive network of leading local products lawyers in 140+ countries across six continents, Cooley is uniquely placed to advise its clients on product issues, wherever they arise.
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