IVDR – Latest EUDAMED Options for Manufacturers
According to IVDR, EUDAMED will not fully functional by the date of application of the IVDR (26 May 2022). Hence the obligations and requirements in the IVDR that relate to EUDAMED shall apply from the date corresponding to six months after the date of publication of the notice of full functionality of EUDAMED.
Until EUDAMED is fully functional, the IVDR stipulates that the corresponding provisions that will continue to apply for the purpose of meeting the obligations lay down in the provisions of IVDR regarding the exchange of information. In addition IVDR clarifies that on registration of devices, and the registration of certificates will start to apply 24 months after the date of publication of the notice.
This White paper presents:
- Application for performance studies
- Substantial modifications to performance studies
- Coordinated assessment procedure for performance studies
- Recording and reporting of adverse events that occur during performance studies
