Topic
Clinical evaluation and post‑market surveillance
Clinical evaluation, PMCF, PMS reports, PSURs and literature searches for medical device software and AI, under EU MDR and UK rules.
Annex XIV
MDR clinical evaluation and PMCF
3
Parts of software evidence, MDCG 2020-1
Art 86
PSURs for class IIa, IIb and III
1 year
Longest PSUR interval for class IIb and III
How we help
Regulatory services →CEPs and CERs
Clinical evaluation plans and reports under MDR Annex XIV, built on MDCG 2020-1 for software.
PMCF
Post-market clinical follow-up plans and evaluation reports that put the performance data your software already logs to use.
PMS reports and PSURs
PMS plans, PMS reports and PSURs for the EU, Great Britain and Switzerland, on the cadence your class requires.
Literature and safety searches
Searches of literature and adverse event databases that can be rerun, with appraisal and a full search log.
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