Clinical Evaluation Report
Clinical Evaluation Report (MDR)
With the stricter European regulations (MDR 2017/745) coming into full effect in 2020, the clinical evaluation report has become a sore point. Regardless of their risk class, all medical devices marketed in Europe are subject to the clinical evaluation process, pursuant to section 6a of Annex I to Directive 2007/47/EC. Notified bodies will expect to see a plan on how the new regulations will be implemented. Full compliance to both the MEDDEV and MDR is expected by May 26, 2020.
ECLEVAR’s Methodology and Time of delivery
Clinical Evaluation requirements have increased dramatically since the release of MEDDEV 2.7.1 Rev 4 in 2016 and the MDR 2017/745 in May of 2017. The process now involves four documents.
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- PMCF Plan
- Clinical development plan (CDP)
A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
(a) a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device.
(b) a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under Articles 62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
(c) a consideration of currently available alternative treatment options for that purpose.
ECLEVAR follow a well-defined procedure to deliver CERs on time:
The first step consists of setting a kick-off meeting to establish with our clients a framework and action plan that defines the time frame to be respected by both parties.
Clinical Evaluation Plan:
The process of CER starts with the clinical evaluation plan. It takes five days for ECLEVAR to write and approve the CEP. In this step, we define the keywords for the state of the art, benchmark device and device under evaluation.
The plan has to be reviewed and approved by ECLEVAR’s medical experts, medical writers and our quality reviewers.
Clinical Evaluation Reports:
This step takes 3 weeks. The CER and the PMCF plan as well as the clinical development plan have to be reviewed and approved by our medical experts, medical writers, as well as our regulatory expert (former auditor within notified body).
ECLEVAR medical writers demonstrate an outstanding range of expertise, with over five years of practice and training at MEDDEV 2.7/1 and MDR 2017/745.
In addition, specialized medical experts work in synergy with our medical writers. Indeed, ECLEVAR has a network of more than 50 medical experts in various therapeutic areas, who review and sign off our CERs.
- With more than 5 years’ experience in MEDDEV 2.7/1, rev 4.
- With more than 50 medical experts.
- Clinical team concept (medical writer and medical experts by therapeutic area).
Equivalent Device under MDR.
Learn more how to conduct medical device equivalence under MDR.
Investigations. See how ECLEVAR can help you to be compliant with MDR.