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.
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 4 documents:
A clinical evaluation shall follow a defined and methodologically sound procedure based on the following:
Kick- off meeting:
The first step consists of setting a kick-off meeting to establish with our clients a framework and action plan that defines time frame to be respected by both parties.
Clinical Evaluation Plan:
The process of CER starts with the clinical evaluation plan. It takes 5 days for ECLEVAR to write and approve the CEP. In this step, we define the key words for the state of the Art, Bench mark device and device under evaluation.
The plan has to be reviewed and approved by ECLEVAR, Medical experts and our clients.
Clinical Evaluation Reports:
This step takes 3 weeks. The CER and the PMCF plan as well as Clinical development plan have to be reviewed and approved by our medical experts, medical writer 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 .
• With more than 50 Medical experts.
• Clinical team concept (Medical writer and medical experts by therapeutic area).
Moreover, ECLEVAR helps clients meet the MDR requirements by using a CER template approved by the notified body (TÜV-SUD).
We know that there is no substitute for excellent project management.
At ECLEVAR, we made it incredibly simple for your team leaders and managers to keep track of absolutely every assignment you trust us with in real time and with high precision, without burdening your team members with additional work.
Also, we engage ourselves in respecting your budget and deadlines (there is no budget overrun).