Manufacturers of IVD devices that do not require Notified Body participation for IVDD but require Notified Body participation for IVDR should complete the DOC as soon as possible (before May 26, 2022) in accordance with IVDD to qualify for the buffer period.
Procedures include:
1) Prepare technical documents in accordance with IVDD 98/79/EC;
2) Designate an authorized representative of the European Union;
3) Complete the IVDD 98/79/EC device registration;
4) Publish DOC files;
5) Implement the post-market surveillance system in accordance with IVDR 2017/746.
Post time: May-27-2022