As promised in December 2022, the European Commission has published a draft legislative proposal extending key transitional provisions for the Medical Devices Regulation (MDR) and removing the sell-off cut-off dates under both the MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The proposed amendments are largely in line with the Commission’s December 2022 briefing note, but provides clarity on the precise dates on which the transitional periods will end and further clarifies the conditions which devices must meet in order to qualify for the extensions. The draft amending act is supplemented by a Q&A.
We have summarized the changes proposed by the Commission below. The amending act must now go through the EU legislative process, starting with an eight-week public consultation (view and comment here). Once adopted, the amending act will enter into force on the day of its publication:
For the MDR, the following changes are proposed:
- Amendments to Article 120(2): the amending act extends the validity of CE certificates issued under the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD) that were: (a) valid on May 26, 2021 (application date of the MDR); and (b) have not been withdrawn by a Notified Body, until the dates laid down in the proposed Article 120(3) (see further below).
For CE certificates which expire prior to the entry into force of the amending act, the extension will be conditional on a manufacturer having signed a contract with a Notified Body for the conformity assessment of the device in question at the moment of expiry. This means, for example, that manufacturers of devices whose CE certificates under MDD or AIMDD are due to expire imminently should seek to contract with a Notified Body for the conformity assessment of those devices as soon as possible.
Failing this, prior to the expiry of the CE certificate, a national competent authority may grant a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR, or have required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR. This means that there is a safety net for devices expiring before the entry into force of the amending act that have not signed an agreement for conformity assessment with a Notified Body, though these routes to qualifying for the extension periods ultimately rely on the discretion of the national competent authorities on a case-by-case basis and therefore attract a level of uncertainty.
- Amendments to Article 120(3): the amending act extends the transitional period for “legacy devices” (meaning devices covered by CE certificates or declarations of conformity issued under MDD or AIMDD in accordance with Article 120(2) of the MDR) as follows:
- until December 31, 2027 (from the current May 26, 2024) for class III devices and class IIb implantable devices, except for certain devices for which the MDR already provides exemptions, namely devices that are based on well-established technologies such as staples, dental fillings, dental braces, tooth crowns
- until December 31, 2028 (from the current May 26, 2024) for other class IIb devices, class IIa devices and for class Is and Im devices (meaning devices placed on the market in sterile condition or having a measuring function)
It is important to note that the proposed extension under Article 120(3) is subject to a number of conditions, some of which still require significant resources and planning by manufacturers:
- the devices must continue to comply with MDD or AIMDD, as applicable
- the devices must not undergo “significant changes” in design and intended purpose (see our 2020 update here and the May 2022 MDCG 2022-6 guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR)
- the devices must not present an “unacceptable risk to health and safety.” The amending act clarifies that the concept of “unacceptable risk to health and safety” is set out in Article 94 and 95 of the MDR. In practice, this does not present manufacturers with a new requirement. According to the amending act, no systematic checks of devices’ safety is required in order to qualify for the extension under this limb. However, where a national competent authority finds that a device presents an “unacceptable risk,” the transitional period will cease to apply
- by May 26, 2024, the manufacturer must have put in place a Quality Management System (QMS) in compliance with Article 10(9) of the MDR. No specific attestation, for example a self-declaration or a verification of the appropriateness of the QMS by a Notified Body, will be needed to meet this requirement. According to the amending act, 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
- by May 26, 2024, the manufacturer must have lodged a formal application for an MDR conformity assessment for the legacy device, and by September 26, 2024 the parties must have signed a written agreement for such conformity assessment. The aim is to ensure that only devices intended to transition to the MDR will benefit from the extended transition period. In practice, that the aim is to avoid unnecessary applications for certification of devices that are intended to be phased out or replaced by new models
The transitional period for class III custom-made implantable devices (currently not covered by Article 120(3)) is also proposed to be extended until 26 May 2026, provided that the conditions of the last bullet point above are met.
- Amendments to Article 120(4): the amending act deletes the current “sell-off” date of May 27, 2025, meaning all devices placed on the market before the end of the transitional period can be made available without time restriction.
For the IVDR:
- Amendments to Articles 110(4) and 112: the amending act deletes the current “sell-off” dates (ranging from May 25, 2025 to May 26, 2028), meaning all in vitro devices placed on the market before the end of the transitional period can be made available without a time restriction.
The amending act must now go through the EU legislative process, starting with the public consultation. At the end of this period, the Commission will present the consultation feedback to the Council and the Parliament to contribute to the debate. Following the consultation, the act anticipates an accelerated adoption with an urgent exception to the usual eight-week period between a draft legislative act being made available to the parliaments of the EU Member States and the date on which it is placed on the provisional Council agenda for adoption. Though there is no formal time limit for the Parliament and Council’s first readings, as the act follows an accelerated co-decision procedure it is likely that the institutions will subsequently adopt the act swiftly.
Whilst this draft legislation does not include any significant deviations from the changes that were outlined in the December briefing note, it is noteworthy that the proposed deadlines for legacy devices are at the end of 2027 and 2028 respectively. This gives manufacturers longer than they might have expected from reading the briefing note which did not provide specific dates.
The additional qualifying conditions for the extended transition periods also now give manufacturers a clearer picture of what they will need to do to keep their devices in conformity. Manufacturers should continue to pay close attention to any proposed changes to this draft legislation as it passes through the legislative process.
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