Resources
Clinical Evaluation
Clinical evaluation of medical devices: CER, clinical data, equivalence, PMCF/SSCP and MDR Article 61 requirements.
11 articles
The Clinical Evaluation Plan (CEP): what it is for and how to structure it
Notified bodies request this steering document before the CER itself, and immediately spot one that fails to identify the device's clinical gaps. Annex XIV, Part A of the MDR sets its mandatory content.
The Clinical Evaluation Report (CER): content, expected level of evidence, lifespan
The clinical evidence level expected rises with the class and the document is updated throughout the life cycle: the MDR sets no fixed frequency, but the PMCF evaluation report and the SSCP of implantable and class III devices are reviewed at least annually.
Demonstrating Clinical Equivalence under the MDR: Criteria, Limits and When It Is Genuinely Possible
Article 61.5 sets three cumulative criteria for equivalence, and citing a competitor's device requires contractual access to its data that almost no company grants. The route stays realistic only with a device from the same manufacturer.
Clinical evaluation under the MDR: what Article 61 actually requires
Article 61 turns clinical evaluation into a continuous process covering every class, class I included. For implantable and class III devices, the PMCF evaluation report and the SSCP are updated at least annually.
PMCF: post-market clinical follow-up — why so many plans fall short
The notified body first checks whether the clinical follow-up answers the CER's precise gaps, the leading reason for rejection. The programme spans the device's entire commercial life, not a two-year window.
PMCF Report (PMCFR) and Summary of Safety and Clinical Performance (SSCP)
One stays in the technical documentation, the other becomes public through EUDAMED under Article 32 of the MDR, mandatory only for implantable and class III devices. Two deliverables often taken one for the other.
Systematic Literature Review for the CER: Method, Databases, Traceability
The systematic character separates a regulatorily acceptable review from a selection of favourable articles. Omitting unfavourable safety data breaches Annex XIV, Part A of the MDR, which requires both favourable and unfavourable data to be taken into account.
MEDDEV 2.7/1 rev 4: still applicable under MDR, and how?
Never formally withdrawn under the MDR, MEDDEV 2.7/1 rev 4 remains the most detailed clinical evaluation method, built in five stages. Notified bodies expect it to be complemented by MDCG guidelines 2020-5, 2020-6 and 2020-13.
Clinical Evaluation of Medical Software (SaMD): Method and Acceptable Sources
Software produces information rather than a physical effect, so its clinical evidence rests on diagnostic performance and real impact on decisions. MDCG 2020-1 deems algorithmic performance alone insufficient.
Clinical evaluation and risk management: how the two processes feed each other
Residual risks validated under ISO 14971 must be confirmed by the clinical data, and GSPR No. 1 of Annex I requires both processes to converge on a single, defensible benefit/risk conclusion.
Clinical Data for Class I Devices: Clearing Up the Misunderstanding
Self-certification concerns the conformity procedure, never the clinical evaluation obligation: Article 61 covers every device. For class I, a documented literature review often suffices, provided it concludes on the GSPR.
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