CLINICAL EVALUATION

EU Regulation 2017/745 on medical devices applies from 26 May 2021.  On that date, the MDR repeals Directives 90/385/EEC and 93/42/EE, respectively on AIMD and medical devices. The scope and emphasis on clinical evaluation is more comprehensive under the MDR than under the Directives.

A MILESTONE

Often required for all classes of medical devices, clinical evaluation ensures that its safety and performance is based on sufficient clinical evidence throughout its life on the market.

REQUEST FOR QUOTE

Eclevar has extensive expertise in the key clinical evaluation requirements of the MDR.

INVESTIGATION vs EVALUATION

• MDR Annex XIV states that the clinical evaluation plan must include information on the clinical development plan ; the information detailed in both plans must be coherent.

• Annex XV requires that the clinical investigations must be consistent with the CEP and that the application for clinical investigation include, among other information, details and/or reference to the CEP.

• Annex XV also requires that the CIP include, among other detailed information, the type of investigation with the rationale for its choice, for its parameters and for its variables, as indicated in the clinical evaluation plan.

Doctor

FOCUS AREAS

Key points need to be considered when preparing a CER under the MDR:

  • Literature searches
  • Clinical investigations
  • Lifetime data
  • General Safety and Performance Requirements (GSPRs)
  • Essential Requirements (ERs)
  • State-of-the-art
  • Benefit/risk conclusions.

A PROVEN EXPERTISE

Our team, composed of several profiles including experienced CER writers, has extensive experience in medical writing, data analysis and is able to support any medical manufacturer.