Time extension of the MDR and IVDR transitory period

On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 was published on the Official Journal of the European Union, thus making official the time extension of the transition period regarding Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

In the “whereas” of this new regulation the reasons at the root of the time extension are restated: the impact of the COVID-19 pandemic on the production system, the imminent risk of shortage for medical devices and in vitro diagnostics, the unpreparedness of SMEs in demonstrating compliance with the requirements of the regulations and the insufficient number of Notified Bodies (NBs) designated according to the MDR (38 MBs so far) as well as to the IVDR (10 NBs so far) not allowing to get through the huge workload deriving from the new requests of certification of legacy MDs and IVDs within the dates provided for by articles 120 and 110, respectively.

The main provisions of Regulation (EU) 2023/607 amending articles 120, 122 and 123 of the MDR are the following:

1. MDs for which the conformity assessment procedure pursuant to Directive 93/42/EEC (MDD) did not require the involvement of a NB and for which the involvement of a NB is required pursuant the new regulation, may be placed on the market or put into service until 31 December 2028 (as per new article 120.3b).
2. MDs covered by certificates issued in accordance with Directive 90/385/EEC (AIMDD) and Directive 93/42/EEC (MDD) that are valid at 20 March 2023, remain valid until 31 December 2027 for all class III devices, and for class IIb implantable devices except WETs, and until 31 December 2028 for the other class IIb devices, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function (as per new article 120.2).
3. MDs covered by certificates issued in accordance with these directives that, on the other hand, have expired before 20 March 2023 are considered to be valid until the dates set out in the previous paragraph only if one of the following conditions is fulfilled (as per new article 120.2):
   1. before the date of expiry of the certificate, the manufacturer and a NB have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device;
   1. a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59(1) of the MDR or has required the manufacturer, in accordance with Article 97(1) of the MDR, to carry out the applicable conformity assessment procedure.
4. Introduction of a transition period for the placing on the market of class III custom-made MDs until 26 May 2026 (as per article 120.7f)
5. Removal of the provision on the so called “sell-off date” as per article 120.4 of the MDR. The “sell-off date” was the date after which MDs already placed on the market and available for purchase should be withdrawn. The deletion of this provision ensures that medical devices already on the market remain available (as per new article 120.4).

The transition periods described under 2, 3 and 4 only apply if the conditions described under new article 120.3d are fulfilled, including the presence of a signed written agreement, in compliance with annex VII, 4.3(2) of the MDR, between a NB and the manufacturer within 26 September 2024.

The only provision that is also applied to the IVDR is the one on the deletion of the “sell-off” provision as per article 110.4 of the IVDR.

The absolute need of this measure can be inferred from the fact that the Regulation becomes urgently effective on the same day of its publication in the Official Journal of the European Union. The hope is that this time extension can provide NBs with the time needed to carry out the requested conformity assessment ensuring the non-stop availability of products that are essential for patients health and preserving, at the same time, high quality and safety levels.

Written by Simone Pippa on 23/03/2023

Foto di Dušan Cvetanović da Pixabay