EU Technical Documentation Assessment Certificate
The Notified Bodies follow chapter II of Annex IX in MDR for the conformity assessment of the technical documentation of the medical device manufacturers and issue EU Technical Documentation Assessment Certificate on conformance to all the obligations of the MDR. The technical documentation should contain the information as per the Annex II.
This certificate is issued to the manufacturers of the medical devices that comply with the conformity assessment specified in chapter II of Annex IX of MDR. It is applicable for all classes of medical devices that require notified body intervention for their CE Marking process. This certificate includes clear product identification (name, model, type of device or devices), intended purpose, risk classification, and Basic UDI- DI. The CE certificates issued are valid for a maximum of 5 years and will be renewed by annual surveillance audit.
For the medical devices incorporating the medicinal substance as per the directive 2001/83/EC, before issuing the above-said certificate, what is the Notified Body required to do?