Notified Body Involvement Annex II defines criteria for the involvement of notified bodies for certain products. As with the MDD, a European addresses would be necessary for non-European IVD manufacturers. Annex II also defines certain rules for the designation and surveillance of notified bodies. The section delineates the proper methods of CE marking and the steps that must be taken when a CE mark is wrongly applied. The Annex also discusses notifications in the case of restriction of products.
Member states have to observe confidentiality, and they have to cooperate.
IVD manufacturers should take a hard look at the lessons learned by their counterparts, the medical device manufacturers, as they tried to comply with the MDD requirements to assure continued uninterrupted access to the European market. Waiting will only cause competitive problems that may not be easy to erase. Dr. Haindl is chairman of the scientific board of MDSS, a company serving as Authorised European Representative for non-European companies. Examples of essential requirements for all products Must be safe. 4 pages Annex IX Evaluation products 2 pages Annex X Criteria for notified bodies 3 pages Annex XI CE mark 1 page Table 8 Registration of manufacturers and devices, Art.