Postponement of the entry into force of the MDR and IVD Regulations (IVDR)
January 17, 2023
At the heart of the debate and the concerns of the sector's players for more than a year, this announcement appears to be a real relief for the entire sector.
On December 9, Stella Kyriakides, European Commissioner for Health and Food Safety, proposed to the European Health Ministers to prepare a legislative amendment to the EU Regulation n°2017/745 on medical devices (MDR) with the aim of amending the transitional provisions initially foreseen for its entry into application. In this context, the European Commission published on January 6, 2023 a proposal for a legislative amendment to the MDR (amendment 2023/0005).
This is a real relief for the sector, which was warning of the risk of medical device (MD) shortages due to the difficulties in meeting the current deadline of 26 May 2024. It should be remembered that these difficulties are the result of various factors: delays in the notification of Notified Bodies (NBs), lack of capacity and insufficient number of NBs to meet the need to renew certificates for the entire sector. These difficulties have also arisen on the manufacturers' side with the updating of the technical files in the light of the new reinforced requirements of the regulation.
The threat of unavailability and disruption of supply was particularly pointed out in view of the large number of DM whose CE marking certificates had not been renewed in time.
Transitional provisions of the MDR extended beyond May 2024
The proposed amendment to Article 120 of the RDM concerning transitional provisions extends the transition period according to the type of device. The following transition periods are proposed:
May 26, 2026 for Class III custom implantable devices;
December 31, 2027 for Class III and IIb implantable medical devices, with the exception of certain devices for which the MDR provides exemptions when they are considered to be based on well-established technologies (sutures, dental crowns, orthodontic appliances, etc.);
December 31, 2028 for other devices (low and medium risk) involving the intervention of a notified body under the MDR.
In practice, the application of these transitional provisions remains subject to conditions
The application of the extended transition period is subject to several cumulative conditions that can be summarized as follows:
The product must continue to comply with Directive 90/385/EEC or 93/42/EEC as appropriate. This condition is already laid down in the MDR (Article 120(3)).
The device does not undergo significant changes in its manufacture and use. This condition is also already present in the same Article 120(3) of the RDM.
The devices do not pose an unacceptable risk to the health or safety of patients, users or other persons, or any other aspect of public health protection.
The manufacturer must have a quality management system (QMS) in place that meets the requirements of section 10(9) of the MDR by May 26, 2024.
The manufacturer must have submitted a new formal application to its NB for conformity assessment of its device under the MDR before 26 May 2024 and the agreement for this assessment between the NB and the manufacturer must have been signed before 26 September 2024.
Removal of the "off-sell" date of May 26, 2025
The abolition of the sell-by date is proposed. This would allow products legally placed on the market to continue to be made available and put into service. The same proposal is made with regard to the EU regulation 2017/246 on in vitro diagnostic devices.
The response of the European Parliament and the Council is awaited. This proposal is to be adopted under an accelerated co-decision procedure. The feedback period is reduced to 18 January 2023. This proposal for a regulation is also subject to a public consultation until 18 January 2023 via the following link. These contributions will be presented to the Parliament in order to feed the legislative debate.