EU MDR deliverable
What the Clinical Evaluation Report has to prove
Under EU MDR 2017/745 the Clinical Evaluation Report is the document in which the manufacturer demonstrates that the clinical evidence supports conformity with the relevant General Safety and Performance Requirements. It is not a literature summary. It is an argument, and a notified body reads it as one.
The CER has to establish three things: that the device achieves its intended clinical benefit, that the risks are acceptable when weighed against that benefit, and that the evidence supporting both is sufficient in quantity and quality for the device’s risk class. A report that recites studies without reaching a defensible conclusion on all three is the most common reason for a deficiency letter.
What we produce
- Clinical Evaluation Plan — scope, intended purpose, target population, clinical claims to be substantiated, the state of the art, and the acceptance criteria against which the evidence will be judged. Written first, because a CER built without a plan cannot show that its conclusions were pre-specified.
- Systematic literature search protocol — databases, search strings, inclusion and exclusion criteria, and an appraisal method. Reproducible, because the notified body will check whether someone else running the same search would find the same papers.
- State-of-the-art review — current standard of care, alternative therapies and benchmark devices, which is what the acceptance criteria are anchored to.
- Equivalence justification where equivalence is claimed — clinical, technical and biological characteristics addressed separately, with the contract for access to the equivalent device’s technical documentation where Article 61(5) requires it.
- Benefit-risk determination traced to the risk management file, not asserted independently of it.
- The Clinical Evaluation Report itself, with the gaps that feed the PMCF plan stated explicitly rather than left for the reviewer to infer.
Where CERs usually fail
- Equivalence claimed too loosely. Since the MDR, equivalence to a competitor device without contractual access to its technical documentation is rarely accepted for implantable and Class III devices. Plan the evidence strategy around what you can actually obtain.
- The literature does not match the intended purpose. Papers on a broader indication, a different patient group or an earlier device generation do not support the claims on your label.
- No link to risk management. The benefit-risk conclusion in the CER and the one in the risk management file must be the same conclusion, reached from the same data.
- Claims in marketing that the CER does not substantiate. Reviewers read the brochure and the IFU alongside the report.
- Never updated. The CER is a living document, refreshed on a frequency justified by risk class and fed by PMCF and PSUR data.
How the work runs
We start with a gap assessment against MDCG 2020-13, the clinical evaluation assessment report template a notified body reviewer works from, because that shows immediately which sections of your existing evidence will survive review. From there we write the plan, run and document the literature search, appraise the results, and draft the report. Where the evidence does not support a claim, we say so and set out the options: narrow the claim, generate data through PMCF, or run a clinical investigation.
Typical duration is six to twelve weeks for a first CER on a Class IIa or IIb device, longer where a systematic review has to cover a crowded literature or where equivalence has to be built from scratch.
Frequently asked questions
Does every device need a Clinical Evaluation Report?
Yes. Article 61 requires clinical evaluation for all classes, including Class I. The depth scales with risk, but the obligation does not disappear at the low end.
Can we reuse the CER we wrote under the MDD?
As source material, yes. As a submission, rarely. The MDR raised the evidence expectations, changed the equivalence rules and requires the PMCF linkage, so an MDD-era report almost always needs rebuilding rather than reformatting.
How often must the CER be updated?
At least annually for Class III and implantable devices, and on a justified frequency for others, typically every two to five years, plus whenever PMS or PMCF data changes the benefit-risk picture.
Do we need a clinical investigation?
Only where the available evidence cannot demonstrate conformity. The CER is where that determination is made and documented, which is why writing the plan first matters.
Who can author a CER?
Someone with documented expertise in the device technology, its clinical application and research methodology. The notified body will ask for the author’s CV and a declaration of interest.
The CER sits inside the wider technical documentation we prepare for CE marking, and the quality system behind it is covered under ISO 13485:2016.