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13 December 2022

An extension of the transitional period for MDR and IVDR

Position paper 2022-14, already discussed here, proposed measures to address the significant and urgent challenges to transition to the MDR and IVDR. Nevertheless, the EPSCO Health Council expressed their concerns related to the implementation of Regulation (EU) 2017/745 and how medical devices shortages can have a severe impact on patient care and public health.


It is estimated by the MDCG that only 30% of medical devices will obtain a valid MDR certificate and 50% a valid IVDR certificate by the due date 2024.


Despite their full support for the MDCG position paper 2022-14, several Member States, some Members of the European Parliament and stakeholders consider that action discussed by the MDCG group will not be sufficient and are calling for additional measures, namely an urgent, targeted initiative to amend the MDR.


For these reasons an extension of the transitional provisions was proposed for in Article 120 MDR linked to certain conditions in order to give manufacturers and notified bodies more time to conduct the necessary conformity assessment procedures.


The Commission presented the likely elements of a legislative proposal for a targeted amendment of the MDR and IVDR during the EPSCO Health Council on 9th December 2022.


Today’s update from the EPSCO meeting on MDR is that all member states were in support of the proposed extensions to the transitional provisions under the MDR. An extension of the transitional period in Article 120(3) MDR with staggered deadlines depends on the risk class of the device.


An extension until May 2027 for class IIb and III devices and until 2028 for class I and IIa is accepted.


They also proposed to extend the validity of certificates issued under the MDR under certain conditions.


The Commission has committed to presenting a legislative proposal at the ‘beginning of 2023’.