If a device incorporates, as an integral part of its operation, an ancillary medicinal substance or companion diagnostics, the notified body must, as part of the conformity assessment process, request the opinion of a competent pharmaceutical regulatory authority on the device.
The notified body can request an opinion from Fimea in cases where an opinion should not be requested from EMA. The opi ...
Medical devices incorporating a medicinal substance
Dossier:
- A cover letter, EMA’ application form (pages 6–17 completed), information about the medical device, a declaration signed by a qualified expert and CV, report of the notified body on the benefits of adding the medicinal substance component, and device labels.
- Quality and clinical summary
- The appropriate quality documentation, CEP/ASMF/PMF
- The appropriate preclinical documentation
- The appropriate clinical documentation
Companion diagnostics
Dossier
- Application form (without page 5)
- Draft instructions for use (IFU)
- Draft safety and performance summary