The MEDDEV 2.7/1 rev 4 guidance was published in June 2016 under Directive 93/42/EEC. It has not been officially replaced since the MDR became applicable. It is a reference document that continues to be cited by notified bodies — but you need to understand exactly what it still covers and what has evolved with the MDCG guidance published after 2021.
What MEDDEV 2.7/1 rev 4 still covers
MEDDEV 2.7/1 rev 4 provides the most detailed available method for conducting a clinical evaluation. Its five-stage structure, its criteria for assessing the quality of clinical data, and its practical appendices on levels of evidence and the methodological quality of studies: all of this remains relevant and expected under MDR.
The notified bodies that review CERs still refer to it. A CER structured according to MEDDEV 2.7/1 rev 4, with the necessary adaptations to MDR requirements, is generally well received.
What the MDCG guidance has changed or clarified
Several MDCG guidance documents published after the MDR became applicable have clarified or tightened certain points that MEDDEV 2.7/1 rev 4 did not cover with the MDR level of requirement.
MDCG 2020-1 (clinical data for SaMD). Clarifies the acceptable data sources and assessment criteria for medical software — a topic that MEDDEV 2.7/1 rev 4 did not address.
MDCG 2020-5 (demonstration of clinical equivalence). Clarifies the criteria of Article 61.5 MDR on technical, biological and clinical equivalence, and reiterates the requirement for contractual access to data for equivalent devices belonging to another manufacturer.
MDCG 2020-6 (PMCF). Clarifies the expected content of the PMCF plan and the PMCF report, with more detailed requirements than MEDDEV 2.7/1 rev 4 on this point.
MDCG 2020-13 (clinical evaluation of implantable devices). Specific requirements for implantable devices under MDR.
How to combine the two in practice
MEDDEV 2.7/1 rev 4 provides the basic method. The MDCG guidance clarifies the specific MDR requirements that go beyond or differ from the directive method. A CER compliant with MEDDEV 2.7/1 rev 4 that incorporates the clarifications of the relevant MDCG guidance is the expected combination.
Not knowing the MDCG guidance and relying solely on MEDDEV 2.7/1 rev 4 produces CERs that miss the specific MDR requirements. Knowing only the MDCG guidance without the methodological rigour of MEDDEV 2.7/1 rev 4 produces structurally weak CERs.
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