SOFTWARE MD/IVD NEWS

Clinical Evaluation Consultation Procedure for a Transcatheter #HearthValve, the delivery system, and its accessories


August 23, 2022

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.


Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.


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