Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023, a proposal (Proposal) to amend the transitional regime under the Medical Device Regulations (MDR) and certain related rules under the In Vitro Diagnostic Medical Device Regulations (IVDR). It is based on suggestions made by the Commission at the end of last year, which we have already discussed on our MoFo Life Sciences blog.
The Commission proposes:
- an extension of the validity of certificates (MDR),
- an extension of the transition period (MDR), and
- the removal of the "sell-off" periods (MDR and IVDR).
As becomes apparent from the above, the changes to the transition periods are limited to the MDR. The transitional regime of the IVDR was extended already at the beginning of 2022, so that the Commission deems the capacity challenges to no longer be so severe for in vitro diagnostics. We discussed the IVDR transitional periods in our previous blog post here.
There is a uniform understanding that an extension of the MDR/IVDR transitional regime is indispensable to combat a potential European health crisis and maintain patients' access to a wide range of medical devices while ensuring the transition to the MDR framework. Our previous blog post discussed the lack of clarity in the Commission's initial suggestions of December 2022 (Initial Suggestions). Among other things, the Initial Suggestions imprecisely specified the conditions to be fulfilled for a device to be covered by the proposed extended transitional periods. In terms of the extension of the validity of certificates, it was also unclear whether certain "legal and practical reasons" would serve as a criterion for such an extension and how the Commission would fill these terms with live. Moreover, it was unclear whether an extension would be granted retroactively to certificates already expired at the time of entering into force of the proposal.
Details of the Proposal
The new Proposal brings more clarity for stakeholders.
Extension of the transition period (Article 1(1), point (b) of the proposal)
The Commission suggests to extend the transition period for higher-risk devices (class III and class IIb implantable devices, except certain devices for which the MDR provides exemptions) from May 26, 2024, until December 31, 2027, and for medium- and lower-risk devices (other class IIb devices and class IIa, Im, Is, and Ir devices) until December 31, 2028.
The extended transitional periods only apply if the following conditions are met:
- devices continue to comply with Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AMDD);
- there are no significant changes in the design and intended purpose;
- the devices do not present an unacceptable risk to the health or safety of patients, users, or other persons, or to other aspects of the protection of public health;
- no later than May 26, 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9) MDR;
- no later than May 26, 2024, the manufacturer, or its authorized representative, has lodged a formal application in accordance with Annex VII, Section 4.3 of the MDR for a conformity assessment in respect of a "legacy device" covered by a Directive's certificate or declaration of conformity, or in respect of a device intended to substitute that device under the MDR, and no later than September 26, 2024, the notified body and the manufacturer have signed a written agreement in accordance with Annex VII, Section 4.3 of the MDR.
The proposed amendment further introduces a transition period until May 26, 2026, for class III custom-made implantable devices, which are currently not covered by Article 120(3) MDR.
Extension of the validity of certificates (Article 1(1) point (a) of the proposal)
The Commission further proposes to amend Article 120(2) MDR to extend the validity of certificates previously issued under the MDD that were valid on the day of the MDR's date of application (May 26, 2021) and have not been withdrawn by a notified body. Certificates are intended to remain valid for the duration of the proposed extended transition period of the respective risk class applicable for the device set forth above.
For certificates that have already expired at the time the amendments to the MDR, as suggested by the Proposal, take effect, the extension would be subject to the condition that, before the date of expiry of the MDD certificate, the manufacturer signed a written agreement with a notified body for the conformity assessment of the device in question. Or if no such agreement has been signed at the time of the expiry of the validity of the MDD certificate, a national competent authority has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 MDR or has required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 MDR.
Removal of the "sell-off" deadline in the MDR and IVDR (Article 1(1), point (c) and Article 2(1) of the proposal)
It is further proposed to remove the current "sell-off" date in Article 120(4) MDR (May 27, 2025) and in Article 110(4) IVDR (May 25, 2025 to May 26, 2028). In this case, devices placed on the market before the respective end of the transition period could be made further available on the market without a legal time restriction.
Assessment of the proposed amendments
Albeit announced for the beginning of 2023, many stakeholders doubted that the Commission would issue the Proposal at this rapid pace. By doing so, the Commission clearly recognized the urgent risks of medical device shortages in the European Union as a result of MDR implementation challenges.
Stakeholders in the industry have already signaled that they very much welcome the proposed extensions. From a legal perspective, the Proposal brings one thing above all: more clarity.
In particular, the conditions to be met for a device to be covered by the proposed extended transitional periods have been clarified. Whereas the Commission's Initial Suggestions vaguely stated that certain steps to initiate certification procedures under the MDR are required, it is now clear that the manufacturer must, among other things, have lodged a formal application for a conformity assessment and have signed a written agreement with such notified body. Of course, this does not mean that manufacturers can lean back and slow down their transition efforts. To the contrary, given the notorious capacity issues at notified bodies, it will be critical for them to move fast to secure a signed contract with a notified body in time.
Moreover, it is a huge step that MDD certificates will be extended and that even MDD certificates already expired at the time of entering into force of the Proposal's amendments will benefit from such an extension. Yet, these manufacturers will have to be able to demonstrate that the devices in question are in "transition" before expiry of the respective MDR certificate. This is not only a prerequisite under the Proposal, which requires a written contract with the notified body, but, according to the position paper of the Medical Device Coordination Group (MDCG) (MDCG 2022-18), also a criterion to obtain an extension by a competent authority pursuant to Article 97 MDR.
Finally, the removal of the "sell-off" period in the MDR and IVDR is a major step toward reducing the risk of overstocking and preventing unnecessary disposal of safe medical devices and in vitro diagnostic medical devices.
The Proposal needs to be adopted by the European Parliament and the Council, and it might still undergo some changes in this process. While it is unclear when and if the proposed amendments will become effective, the previous corrigenda of the MDR have demonstrated that adoption can be swift, which in this case is necessary to ensure that patients and healthcare systems have continuous access to all categories of medical devices. At the moment, stakeholders should further pursue their transition strategy but should closely monitor these critical developments in the coming months. Watch this spot for more updates on this and other EU regulatory matters.
Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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