Key takeaways
In particular, the proposed amendment provides for the introduction in the MDR and in the IVDR of a new Article 10a which imposes on the manufacturer the obligation to notify the competent authorities, economic operators, and healthcare institutions of the early termination of the supply of certain medical devices and in vitro diagnostic devices when such termination has the potential to cause serious harm or even a mere risk to patients or public health.
With specific reference to the MDR, the proposal also provides for the amendment of several provisions concerning the use of Eudamed, including those in Article 34. In particular, the purpose of these amendments is to remove the concept that the use of Eudamed can only become mandatory when all its modules have been declared fully functional. Indeed, the new wording of the provisions enables a gradual implementation of individual Eudamed modules once they have been audited and declared functional.
As regards the IVDR, the proposed amendment also intervenes on Article 110 by providing for, among others, the extension until 31 December 2027 of the validity of certificates issued under Directive 98/79/EC that are still valid on the date of application of the IVDR (26 May 2022) and have not been withdrawn by a notified body and, with respect to "legacy devices" covered by a certificate or declaration of conformity issued under the above Directive before 26 May 2022, the extension of the relevant transitional periods based on the class of the device.
