What is a clinical evaluation report under EU MDR?
A clinical evaluation report (CER) is the document required by EU MDR 2017/745 that demonstrates, with clinical evidence, that a medical device is safe and performs as intended. It follows MEDDEV 2.7/1 rev.4 methodology and is assessed by your Notified Body as part of CE marking.
Why do most CERs receive major non conformities?
The most common root causes are missing Annex XIV residual risk to evidence traceability, equivalence claimed under Article 61(4) without a documented similarity demonstration, literature reviews that fail MEDDEV 2.7/1 Section 9 methodology, PMCF plans not linked to specific CER gaps, and no defined state of the art benchmark.
How does Eclevar demonstrate equivalence under Article 61(4)?
We build the full three dimensional similarity matrix covering technical, biological and clinical characteristics before any equivalence claim is made, so the Notified Body receives documentation rather than assertion.
Who writes and reviews the CER at Eclevar?
CERs are authored by our medical writing team led by Pierre-Marie Boutanquoi and reviewed against Notified Body assessment logic by senior clinicians including Prof. Mark DaCosta, a former senior reviewer at a Notified Body (TUV SUD), before submission.
How long does a Notified Body CER cycle take with Eclevar?
A typical submission goes through 3 to 4 question and answer rounds, with each round adding months. Eclevar targets a single round: pre submission alignment, a complete evidence architecture at first submission, then minor clarification queries only.
Should I hire a CER consultant or a CRO for my clinical evaluation?
It depends on scope. A consultant fits a targeted problem: one deficiency, one equivalence file, one methodology rebuild. A CRO fits when the CER depends on wider evidence work: literature review at scale, PMCF data, registries and Notified Body Q&A management. Eclevar covers both models: consultant level seniority, including a former Notified Body reviewer, with the medical writing team and data infrastructure of a CRO behind it.
Can Eclevar remediate a CER that already received a non conformity?
Yes. Remediation mandates start with a gap assessment of the deficiency letter, then we rebuild the failing element, equivalence, SLR methodology, traceability or PMCF linkage, and draft the response in the structure reviewers expect.
How are the CER and the PMCF plan connected?
Under EU MDR each PMCF objective should close a specific evidence gap identified in the clinical evaluation. Eclevar co-authors the CER and the PMCF plan as two sides of a single evidence strategy, with direct gap mapping.
