Last week the European Parliament voted for the amendment of the MDR and IVDR, which was previously proposed by the European Commission.
The insufficiency of the capacity of the MDR designated notified bodies led to the risk of shortages of medical devices in the Union, that were certified under the MDD/IVDD.
Recently adopted Regulation prolongs the transitional period of MDR/IVDR:
– Till the end of 2027 – for class IIb and III devices;
– Till the end of 2028 – for other risk class medical devices.
Moreover, the amendment provides new opportunities for manufacturers, whose medical device certificates expired, to continue placing their medical devices on the market after fulfillment of the requirements, such as:
– before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement for the conformity assessment;
– a competent authority of a Member State has granted a derogation from the applicable conformity assessment procedure or has required the manufacturer to carry out the applicable conformity assessment procedure;
Despite that the MDR/IVDR amendment will come to force only after publication in Official Journal, which may happen shortly, you can plan your activities already now.
Do you think you may benefit from the provisions of new EU medical device legislation? Starodub team is ready to provide you with any relevant clarifications and support! Don’t hesitate to contact us.
