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Clinical & Postmarket

Documents for clinical investigation and evaluation, postmarket surveillance, complaints, reporting and field actions.

Documents for clinical investigation and evaluation, postmarket surveillance, complaints, reporting and field actions.…

21 products

Choose clinical and post-market documents by activity

Separate planning from reporting. A Clinical Investigation Plan sets out a prospective study; the Clinical Investigation Report records its methods and results. A PMCF Plan defines future follow-up activities, while the PMCF Evaluation Report evaluates findings from completed activities.

Clinical Evaluation connects evidence appraisal and analysis with the CER. Post-Market Surveillance organizes broader real-world information and feedback. Complaint Handling, Complaint Trending, Vigilance and Medical Device Reporting support different assessment and escalation activities.

FDA Medical Device Reporting and the EU Medical Device Regulation both use the abbreviation MDR in different contexts. Check the product title and market scope. Review the individual contents and related bundles before selecting documents for your device and activities.

Clinical evaluation and PMCF bundle

Clinical investigation procedure and related documents

Practical guides

Connect clinical evaluation and investigations with PMCF, surveillance and the relevant reporting workflows.

Clinical Evaluation Reports: Turning Medical Device Evidence into Conclusions

PMCF Plan vs PMCF Evaluation Report: What Each Document Does

Clinical Investigation Documents: Plan, Investigator Brochure and Report

Medical Device Post-Market Surveillance and PSUR Planning

FDA MDR, EU Vigilance and Medical Device Recall Workflows

Choose clinical and post-market documents by the evidence decision

Use this hub when planning clinical evidence, following up a marketed device or organizing safety information. Begin with the device’s claims, markets and current evidence gaps. Clinical evaluation, PMCF, broader surveillance and event reporting connect, but their documents are not interchangeable.

Your decision	Starting point	What to check
Claims need an evidence-based conclusion	Clinical Evaluation / CER	Assess relevance, limitations and unresolved questions.
Future clinical follow-up needs planning	PMCF Plan	Define an objective, suitable method and timetable.
Completed follow-up needs evaluation	PMCF Evaluation Report	Analyze actual findings, deviations and implications.
Ongoing field information needs a collection process	PMS Procedure	Connect information sources with analysis and action.
A periodic safety output applies	PSUR Procedure	Check device applicability and the relevant reporting route.
A clinical investigation is being organized	Clinical Investigation Procedure or focused study documents	Distinguish the prospective plan, investigator information and completed report.

What to address first

Start with the clinical-evaluation guide to connect claims and evidence, then use the PMCF and PMS guides for the continuing evidence program. If an individual event may need reporting or field action, use the reporting workflow promptly; periodic reporting should not become a reason to defer that assessment.

Individual document, bundle or existing system?

The clinical bundle includes Clinical Evaluation, PMCF Plan, PMCF Evaluation Report, PMS and Clinical Investigation. PSUR is separately listed. The broader Clinical Investigation Procedure already includes study-plan, report and investigator-brochure material described in its listing; check overlap before also purchasing standalone versions.