Medical device CE marking

European Commission issues Q&A on Article 10a of the MDR/IVDR

2024-10

It is a Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

There are answers to the following 14 questions:

  1. From when does the new Article 10a of the MDR/IVDR apply?
  2. To whom does the obligation to inform of an anticipated interruption or discontinuation of supply of certain devices under Article 10a(1) of the MDR/IVDR apply?
  3. To which “certain devices” does Article 10a(1) of the MDR/IVDR apply?
  4. Who should the manufacturer inform under Article 10a (1) of the MDR/IVDR?
  5. When should a manufacturer inform under Article 10a (1) of the MDR/IVDR?
  6. What is meant by “exceptional circumstances” in Article 10a (1) second subparagraph of the MDR/IVDR?
  7. What is meant by the “anticipation of an ‘interruption or discontinuation’ of the supply of a device” as outlined in Article 10a (1) of the MDR or IVDR?
  8. What are the categories of reasons for the interruption or discontinuation which the manufacturer would be expected to specify in its notification to the competent authority under Article 10a (1) of the MDR/IVDR?
  9. What is considered as an ‘interruption or discontinuation that may result in serious harm or a risk of serious harm to patients or public health’ in one or more Member States under Article 10a (1) of the MDR/IVDR?
  10. Is the information provided to the competent authority subject to Article 109 MDR/102 IVDR?
  11. How should the information to the competent authority under Article 10a be provided?
  12. Which information should be included in the ‘Manufacturer Information Form’2 for notification to the competent authority under Article 10a?
  13. What is the responsibility of other economic operators in the supply chain under Article 10a(3) of the MDR and IVDR after receiving the information from the manufacturer?
  14. Does Article 10a of the MDR/IVDR apply to system or procedure packs?

The Q&A can be downloaded in our library.

Source: European Commission