Change of the MDR and IVDR transitory period: where are we?
On 6 January 2023 the European Commission has adopted a proposal to change the provisions regarding the transitory period for Regulation (EU) 2017/745 (MDR) and Regulation (UE) 2017/746 (IVDR), as announced in a press release published in the website of the European Commission.
The main reason underlying this decision is very well known to those operating in this sector and can be summarised as the insufficient number of Notified Bodies designated according to both Regulation (EU) 2017/745 (36 NBs so far) and Regulation (UE) 2017/746 (8 NBs so far), thus not allowing to clear out the huge workload given by the new requests of MD and IVD legacy certification within the deadlines provided for by articles 120 and 110, respectively.
During the last months of 2022, several interested parties (the so called “stakeholder”) had drawn the attention on this topic, asking at different staged for the implementation of some measures to solve the possible shortage of medical devices in the European Market. In December, the EPSCO Council has announced the arrival of this proposal.
The proposal
We are reporting below the main proposal’s provisions affecting the MDR:
- Extension of the transition periods as per article 120.3 based on the risk class of the devices, with a new deadline until 31 December 2027 for class III and IIb medical devices (high-risk MDs) and until 31 December 2028 for class IIa and I devices, whose conformity assessment procedures will involve a NB.
- Extension of the validity of CE certificates released according to Directive 93/42/EEC (MDD) and Directive 90/385/EEC (AIMDD), in order to cover the time extension provided for above.
- Introduction of a transition period for the marketing of class III customised MDs until 26 May 2026.
- Application of the introduced transition periods only if one of the following conditions is met:
- An agreement has been signed between the MD manufacturer and the NB for the conformity assessment of the MD according to the MDR (as provided for by Annex VII, 4.3) before the certificate expiry date (26 May 2024 at the latest);
- A Competent Authority of a Member State has granted a waiver to the conformity assessment procedure applicable according to art. 59 or has requested that the manufacturer carries out an applicable conformity assessment as per art. 97.
- Removal of the provision on the so-called “sell-off date” (i.e. the date to sell of the stocks) as per article 120.4 of the MDR. The “sell-off date” is the date after which the MDs, already on the market and available for purchase, must be withdrawn. The deletion of this provision ensures that the medical devices already on the market remain available.
The only provision that is also applied to the IVDR regards the latter, i.e. the removal of the “sell-off” as per article 110.4 of the IVDR.
The next steps
The adoption of the proposal by the Commission does not include the starting of a legislative process. The proposal now needs to be adopted also by the Parliament and by the European Council by a joint accelerated procedure.
It would be better to stress that when the concerned proposal has become official, manufacturers and other economic operators will no longer be able to further delay the matter, because it is anyway necessary to obtain a written agreement with a Notified Body before the expiry of the certificate released according to the MDD for one’s medical devices.
Di Renzo Regulatory Affairs is available to support MD and IVD manufacturers and other economic operators with their advising in order to comply with the new deadlines.
Written by: Daniele Scarpino
