On 6 January 2022, the European Commission published a draft Regulation to extend the transition periods under the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostics Medical Devices Regulation (IVDR). The draft amendment Regulation details the Commission’s package of proposals to the EPSCO meeting of Health Ministers late last year.

The draft Regulation provides a relatively generous set of measures to extend the transition periods that should significantly alleviate the imminent risk of devices being forced off the market at the end of the transition periods.

Key aspects of the draft Regulation include:

• Extension of the transition periods during which devices with MDD[1] or AIMDD[2] certificates can continue to be placed on the market or put into service to:
  • 31 December 2027, for class III and most class IIb implantable devices; and
  • 31 December 2028, for other class IIb, class IIa and class I sterile and measuring devices.
• Extension of the validity of MDD and AIMDD certificates (and resurrection of certain already expired certificates).
• Extension of the transitional period for “up-classified” devices – devices for which the conformity assessment did not involve a Notified Body under MDD but will under MDR can continue to be placed on the market or put into service until 31 December 2028.
• Removal of the end of the so-called “sell-off” periods under each of the MDR and IVDR – devices lawfully placed on the market under the applicable transitional provisions can continue to be made available indefinitely.
• Introduction of additional conditions for manufacturers to satisfy in order to benefit from the extended transition periods under the MDR.

As is the case under the existing transitional provisions, manufacturers placing legacy devices on the market under the transitional provisions will still need to comply with the post-market surveillance, market surveillance, vigilance and registration provisions in the MDR rather than the relevant Directive.

The draft Regulation also details the transfer of responsibility for surveillance of legacy devices to a new Notified Body.

Extension (and resurrection) of MDD and AIMDD certificates

Since the proposal by the Commission to the EPSCO meeting, the most common question was how expiring, or expired, MDD or AIMDD certificates would be handled. Thankfully for industry, patients, and clinicians, the Commission has adopted a generous approach. Certificates still valid when the amendment Regulation takes effect will be automatically extended until the end of the applicable transition period for the risk class of the device, as set out above.

Notably, certain device certificates which have already expired when the Regulation takes effect will be resurrected and will remain valid for the respective period set out above. This is, however, subject to meeting one of the following conditions:

1. before the expiry of the certificate, the manufacturer had contracted with a Notified Body for the assessment in respect of the device or a substitute device; Or
2. a competent authority has granted a derogation under Article 59(1) or applied Article 97(1) to the device in question.

Accordingly, we expect each manufacturer to immediately assess whether each device in its portfolio with an expired certificate benefits from these provisions. Specifically, manufacturers will need to confirm whether a relevant contract with a Notified Body was signed before the certificate expiry. If not, then they will need to consider requesting a derogation from a competent authority or the application of Article 97.

Additional conditions to rely on the transitional provisions under MDR

While extensive, the draft Regulation is not a complete “get out of jail free” card. Manufacturers must comply with certain conditions by specified dates to benefit from the transition periods in the MDR. In addition to the conditions that already applied to the transitional provisions under MDR, the manufacturer must no later than:

1. 26 May 2024, implement an MDR-compliant quality management system;
2. 26 May 2024, lodge a formal application with a Notified Body in accordance with the MDR for assessment of the same or a substitute device; and
3. 26 September 2024, sign a contract with a Notified Body for that assessment.

Conclusion and next steps

The amending Regulation is in draft form and could, in principle, be amended as it needs to be agreed between the European Parliament and Council. However, given that the substance of the proposals are in response to pressure from Member States and MEPs, as well as the consequences of not adopting proposals being severe, it seems unlikely that the draft Regulation would be subject to major changes.

Manufacturers should begin considering whether any of their devices may not benefit from the revised transitional provisions as proposed, or whether they need to take any additional actions to ensure a device can benefit from the provisions.

The draft amending Regulation will be subject to an accelerated adoption procedure and will enter into force (including the amendments to the MDR and IVDR it contains) immediately on the date it is published in the Official Journal of the European Union.

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[1] Medical Devices Directive 93/42/EEC
[2] Active Implantable Medical Devices Directive 90/385/EEC