On February 16, 2023, the European Parliament adopted legislation that amends the transitional provisions of the European Union (EU) Medical Devices Regulation (MDR) and removes the sell-off provisions in the MDR and the In Vitro Medical Devices Regulation (IVDR). With its adoption, companies will now be able to plan for transitioning their products to MDR compliance with the knowledge that they have until December 31, 2027 or 2028 to do so depending on the device class.
The European Commission announced the original intention to extend the transitional provisions in December 2022 and put forward a legislative proposal in January 2023. The legislation was swiftly adopted at first reading with no amendments by EU legislators.
For an analysis of the extensions and their impact on the EU medical devices industry, see our Sidley Update describing the key amendments.
As the European Council agreed to approve the European Parliament’s position at first reading in January 2023, the legislation will now be published in the Official Journal of the European Union and become applicable on the same day.
As we have described in our update, the extension of the transitional provisions also covers products with CE certificates issued under the Medical Devices Directive (MDD) set to expire before the date of application. According to the amended Article 120(2), the extension of validity for these devices will, however, apply only if one of the following conditions is met:
- The manufacturer has signed a written agreement with a Notified Body for the conformity assessment of the device in question at the moment of expiry,
- a national competent authority has granted a derogation from the applicable conformity assessment procedure in accordance with Article 59 of the MDR; or
- a national competent authority has required the manufacturer to carry out the conformity assessment procedure within a specific time period in accordance with Article 97 of the MDR.
Though many questions remain regarding implementation of the amended MDR and IVDR, the EU legislators have acted to provide the industry with some breathing space as companies transition to MDR and IVDR compliance. We will monitor further updates as the adopted legislation passes into law and the legislators clarify the new transitional arrangements.
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