EU TYPE-EXAMINATION CERTIFICATE
According to the conformity assessment of the medical device through the type-examination procedure as per Annex X, the Notified Body examines and assesses the Technical Documentation, relevant life cycle processes and a representative product sample conforms to the MDR. They verify that the type has been manufactured in conformity with that documentation.
Either the Notified Body tests the necessary parameters required to check the conformity of the safety and performance or examines the test results submitted by the manufacturer.
The notified body issues the EU Type-Examination certificate to the manufacturer of medical devices if they comply with the conformity assessment specified in Annex X of MDR. This is applicable for the class III and IIb medical devices. This certificate includes clear product identification (name, model, type of device or devices), intended purpose, risk classification, and Basic UDI– DI. The re-certifications shall occur at least every five years.
If a medical device with the EU Type- Examination Certificate, for what changes on the device do the manufacturer required to inform the Notified Body? For which changes the Notified Body will issue a supplement to the EU Type-Examination Certificate?