When medical device products enter the European market, they often need to pass CE certification. The in vitro diagnostic medical device directive (in vitro diagnostic medical devices Directive (98/79/EC), hereinafter referred to as IVDD), which was originally followed by CE certification, will be subject to the in vitro diagnostic medical device regulation (in vitro diagnostic medical device) from May 26, 2022. Regulation (EU) 2017/746, hereinafter referred to as IVDR).
A significant change in the transition from IVDD to IVDR is that more IVD product conformity assessments require the involvement of notified bodies. Currently, only a relatively small number of high-risk products (approximately 8% of IVDs on the market) need to be submitted to a Notified Body for review as required by the IVDD. After the implementation of IVDR, about 80% of in vitro diagnostic reagents need to be reviewed by notified bodies.
In addition to the CE of Class A products, which can be registered in the European Union, European generation, and IVDR technical documents compliance path, CE of Class B, C, and D all need to be certified by a notified body. At present, there are only 5 notified bodies that have obtained IVDR. , and these notified bodies are not yet ready to accept IVDR cases due to personnel qualifications and other issues.
Whether it is a novel coronavirus antigen detection kit, a novel coronavirus neutralization detection kit, or a novel coronavirus nucleic acid detection kit, in accordance with the classification rules of Directive 98/79/EC, it is used for the diagnosis of novel coronavirus used by professionals. Reagents are products outside of List A and List B. Its CE compliance procedure is a declaration of conformity, including the preparation of technical documents by the enterprise, the signing of the declaration of conformity, the designation of an EU authorized representative, and the completion of the EU member state competent authority registration by the EU authorized representative.
Post time: May-27-2022