On 6 January 2023, the European Commission published a draft amending act (“Proposal“) extending transitional provisions under the EU Medical Devices Regulation (MDR). The Proposal extends the validity of certificates issued under the previous Directives (based on certain conditions), giving manufacturers more time to obtain MDR-compliant certificates. We expect that the Proposal will be adopted into law in the coming weeks.
The Proposal puts to bed the big question that was left unanswered by the Commission’s previous announcement on an MDR extension: how would the Commission address devices with expiring certificates under the Directives? Manufacturers now need to assess whether their devices benefit from the Proposal’s revised transitional provisions, or whether they need to act to ensure devices may benefit from the Proposal.
i. Amendment to Article 120(2)
This extends the validity of CE certificates issued under the Directives that: (a) were valid on 26 May 2021; and (b) have not been withdrawn by a Notified Body, until the dates set out in the amended Article 120(3) (see below). The extension is directly applicable, so Notified Bodies are not required to change the date on the individual certificates.
For CE certificates which expire prior to the Proposal coming into force (we expect the Proposal will enter into force in the coming few weeks):
- The extension is conditional on the manufacturer signing a contract with a Notified Body for the conformity assessment of the device in question at the moment of expiry.
- If this has not occurred, prior to the expiry of the CE certificate, a national competent authority may: (i) grant a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR; or (ii) require the manufacturer to carry out the conformity assessment procedure within a specific time period under Article 97 of the MDR.
ii. Amendment to Article 120(3)
This extends the transitional period for devices covered by CE certificates or declarations of conformity issued under the Directives (i.e., “legacy devices”). The Proposal extends the transition period from 26 May 2024 to:
- 31 December 2027 for class III devices and class IIb implantable devices (except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors).
- 31 December 2028 for other class IIb devices, class IIa devices and for class Is and Im devices.
Manufacturers will need to fulfill certain conditions to rely on the proposed extension under Article 120(3):
- The devices continue to comply with the Directives.
- The devices do not undergo significant changes in design and intended purpose.
- The devices do not present an unacceptable risk to health or safety. The concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR. No systematic check of the device’s safety is required.
- No later than by 26 May 2024, the manufacturer has put in place a Quality Management System (QMS) in compliance with Article 10(9) of the MDR. No specific attestation, i.e. no a self-declaration or a verification of the appropriateness of the QMS by a Notified Body, is required. The submission of an application for conformity assessment to a Notified Body will be interpreted as an implicit confirmation that a QMS is in place and compliant with MDR.
- No later than by 26 May 2024, the manufacturer has lodged a formal application for an MDR conformity assessment for the legacy device, and by 26 September 2024 the parties have signed a written agreement for such conformity assessment.
The Proposal introduces a transition period until 26 May 2026 for class III implantable custom-made devices, which are currently not covered by Article 120(3) MDR. This provides manufacturers with more time to obtain certification by a Notified Body. In this case, the transition period is subject to the manufacturer applying for a conformity assessment of devices of this type before 26 May 2024.
iii. Deletion of MDR and IVDR sell-off deadlines
The Proposal deletes the current ‘sell-off’ date of 27 May 2025 in Article 120(4) MDR, and 25 May 2025 to 26 May 2028 in Article 110(4) IVDR. This means that devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.
iv. Timing to bring the Proposal into force
The European Council and Parliament will now consider the Proposal, and it is expected to be adopted in its current form in its first reading. There is no formal time limit for the Parliament and Council’s first reading, but it will follow an accelerated co-decision procedure and is likely to be adopted within a few weeks.