Capture REX EN

Regulation (EU) 2017/745 (MDR) puts the patient at the center of its scope. This is an important development to strengthen the medical devices’ safety for the patients’ benefit. The clinical evaluation is therefore the central document of the technical documentation. The purpose of the clinical evaluation is to verify the safety and performance of the device, including clinical benefits. The clinical evaluation is the focus of all attentions, particularly the regulatory organizations: European Commission, Competent Authorities, Expert Panels, or Notified Bodies.

In addition, when the manufacturer should prepare a Summary of Safety and Clinical Performance (SSCP) per MDR Article 32, the clinical data will no longer be the manufacturer’s confidential data, but data accessible to all via EUDAMED. The clinical evaluation thus becomes a central step in the products conformity assessment under MDR.

In this newsletter, the GMED teams share their experience of the last two years on clinical evaluation. You will then be able to learn about the findings and good practices to be implemented for your clinical evaluation report(s).



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