EU MDR · MDCG · Guidance
MDCG guidance, translated into what you actually do.
MDCG guidance is not law, but Notified Bodies apply it as if it were. This hub explains what the MDCG is, and how its key documents shape classification, clinical evaluation, PMCF and clinical investigations.
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Read the way Notified Bodies read it.
MDCG guidance is interpretation. Ours is written by people who applied it from the reviewer’s chair.
Pierre-Marie Boutanquoi
CERs and PMCF plans under EU MDR and MEDDEV 2.7/1 Rev 4, and Notified Body deficiency response.
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Dr Mark DaCosta
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What the MDCG is, and why it matters.
The Medical Device Coordination Group issues guidance to harmonise how EU MDR is applied. It is not legally binding, but in practice a Notified Body will expect you to follow it.
01
What the MDCG is
The Medical Device Coordination Group brings together Member State experts to issue guidance that harmonises the application of EU MDR 2017/745 across Europe. Its documents clarify grey areas the Regulation leaves open, and Notified Bodies treat them as the working standard.
02
Clinical evaluation & claims
MDCG 2020-5 (equivalence) and MDCG 2020-6 (sufficient clinical evidence for legacy devices) shape how your Clinical Evaluation Report (CER) is judged, and how intended purpose and claims are substantiated.
Where it bites
- Equivalence now needs contractual access to the equivalent’s technical file (MDCG 2020-5)
- Legacy devices must show sufficient clinical evidence, not just history (MDCG 2020-6)
- Intended purpose and indications are distinguished and must be evidenced
03
Clinical investigations
MDCG 2021-8 provides the application and notification forms for clinical investigations while EUDAMED is delayed, and MDCG 2021-20 and 2020-10 cover CIV-ID generation and safety reporting. Together they define how a study is submitted and run.
04
How to use the guidance
The winning approach is to build the technical file the way the relevant MDCG documents expect, so a reviewer can trace every decision to a recognised interpretation. We map each part of your file to the guidance a Notified Body will apply.
MDCG at a glance
Guidance that runs the review.
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