Clinical evaluation of medical device

Clinical evaluation of medical devices is an essential part of CE marking. It is mandatory to sell a medical device in the EU market.

According to EU MDR, medical device manufacturers have to provide evidence of clinical evaluation proving the safety and efficacy of the device. Clinical evaluation is evidenced by a Clinical Evaluation Report (CER). CER is required to be updated by the team of authors throughout the entire life cycle of the medical device. According to the MEDDEV 2.7/1 Rev. 4, a team of authors should have comprehensive competencies and high qualification.

The clinical evaluation team at Pharmaxi has corresponding experience in performing the clinical evaluation of medical devices. The team of authors therefore can do the clinical evaluation according to MDR on a turn-key basis.

In many cases, the Clinical evaluation report could cover all aspects of the EU MDR requirement for clinical evidence. If significant gaps are identified, they could be covered by 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.