This scientific opinion reflects the views of independent experts (#MDR Article 106) on the #clinicalevaluation
assessment report (CEAR) of the #notifiedbody. The advice is provided in the context of the clinical evaluation
consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices (MDR Article 54 and Annex IX, Section 5.1).
The devices examined did not have a CE mark for the two intended purposes:
- failure of an aortic surgical bioprosthetic valve at all surgical risks (only the Transcatheter Heart Valve system was CE Mark for use in patients at high or greater surgical risk), and
- failure of an #aortictranscatheter bioprosthetic or surgical mitral bioprosthetic valve.
Three registries provided clinical data to support the expanded indications for use.
Severe health issues occurred as early as a 12-month follow-up period, but the #medicaldevice is intended to be used long-term in patients treated for the intended purposes. And limited data is available.
The expert panel conclusion is in the section 2.4 in the attached file.