Clinical evaluation of medical device

The clinical evaluation of medical devices is an essential part of CE marking and is mandatory for selling a medical device in the EU market.

According to the EU MDR, medical device manufacturers must provide evidence of clinical evaluation to prove the safety and efficacy of the device. This evaluation is documented in a Clinical Evaluation Report (CER), which must be updated by a team of authors throughout the entire life cycle of the medical device. According to MEDDEV 2.7/1 Rev. 4, the team of authors should possess comprehensive competencies and high qualifications.

The clinical evaluation team at Pharmaxi has extensive experience in performing clinical evaluations of medical devices. Therefore, the team of authors is capable of conducting the clinical evaluation according to MDR on a turn-key basis.

In many cases, the Clinical Evaluation Report can cover all aspects of the EU MDR requirements for clinical evidence. If significant gaps are identified, they can be addressed through a clinical study, clinical trial, or another type of clinical investigation.

The Clinical evaluation of medical devices may include the following services:

Clinical Evaluation Plan (CEP) development.
Clinical Evaluation Report (CER) development
Technical documentation gap analysis.
Remediation of Technical Documentation.
Systematic literature review.
Updating clinical evaluation after CE marking with CEP and CER developing.

We are keen to fulfill the sponsor’s expectations and deliver the highest quality result.