Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.
The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.
In essence, the proposal extends the period companies have to obtain MDR-compliant certificates and also provides more time for Notified Bodies to clear the backlog in their conformity assessments.
The main elements addressed in the proposal are:
- For medical devices approved under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) covered by a certificate or a declaration of conformity issued before 26 May 2021, the relevant transition periods will be extended:
- to 31 December 2027 for high-risk devices (class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors); and
- and to 31 December 2028 for medium and low-risk devices (class IIb devices other than those covered in the foregoing point, for class IIa devices, and for class I devices).
- The extensions set out above will only apply to devices that are considered “safe” and for which the manufacturers have taken steps to transition to the MDR (initiate MDR conformity assessment and implement a QMS both no later than 26 May 2024).
- The transition period for class III implantable custom-made devices will be extended to 26 May 2026, subject to the manufacturers of such devices applying for a conformity assessment before 26 May 2024.
- To allow for the above, the proposal will extend the validity of certificates issued under the MDD prior to 26 May 2021 (the date on which the MDR became applicable).
- The removal of the “sell-off”-deadline established in the MDR and the IVDR, after which MDD/IVDD/AIMDD-certified medical devices already placed on the market had to be withdrawn. This will ensure that healthcare systems and patients will continue to have access to safe and crucial medical devices that are already on the market.
The proposal obviously gives the medical device industry more time to transfer their devices from MDD (and AIMDD) to the MDR. This also reduces the capacity issues of the Notified Bodies. Nevertheless, the extended timelines only apply if certain conditions are met and these include that the manufacturer company must have applied for the MDR-based conformity assessment with a Notified Body no later than 26 May 2024. Further, the manufacturer must have put in place a quality management system in accordance with the MDR no later than 26 May 2024. Hence, despite the extended timelines there is still a lot of work to do for device companies and the Notified Bodies.
Even though the new extended timelines would provide device manufacturers some relaxation, it still remains to be seen whether they will be sufficient in light of the significant implementation issues of the MDR.
The proposal also clarifies that the MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to the above “extended” devices in place of the corresponding requirements of the MDD and AIMDD.
As discussed in our separate blog last month, the EU’s Medical Device Coordination Group (MDCG) released new guidance (MDCG 2022-18) on the use of the non-compliance procedure under Article 97 of the MDR for devices that do not yet comply with the MDR. Article 97 MDR, even if not designed for these MDR transition and implementation issues, formally enables such medical devices to continue to be available on the market if they do not pose an unacceptable risk to the health or safety of individuals or to public health. In the EU Member States, manufacturers and regulatory authorities have already been discussing the Article 97 MDR route ahead of this new MDCG guidance as a means to cope.
The new proposal, along with the MDCG Article 97-MDR-guidance, shows that the European Commission is working towards resolving the issue of the large number of devices yet to transition to the MDR. As noted, the proposal also “helps” the diagnostics industry by removing the sell-off period from the IVDR. The need to transition (a huge number of) IVDs from the IVDD to the IVDR will likely cause an even more delicate regulatory situation than the device industry has been facing with the MDR. In particular, the diagnostics industry and pharmaceutical companies engaged in companion diagnostics (CDx) should take steps as early as possible to secure compliance with IVDR.
As to next steps, the proposal now has to be adopted by the European Parliament and Council, using an accelerated co-decision procedure. The Covington medical device team will continue to monitor this process and provide further updates.