During the transition period of IVDR extension until May 26, 2025, manufacturers of new crown reagents can apply for EU registration, EU generation, CE technical documents, and DOC to complete CE compliance export to EU according to IVDD other category.
On October 14, 2021, with only a few months left before the official implementation of IVDR, the EU issued a proposal to delay the implementation of IVDR. The proposal analyzes the current implementation progress of IVDR. As of September 9, 2021, only 31 IVDR certificates (B and C) have been issued in the world, and no D certificates have been issued.
During the IVDD period, there were about 3,300 devices that required the participation of notified bodies, and this data increased to 24,000 under the IVDR. According to the original plan, NB does not have enough ability to accept in time, which may lead to the risk of market out of stock.
Post time: May-27-2022