The audit-ready clinical and post-market documentation kit for Regulation (EU) 2017/745. Cover the full lifecycle — from Clinical Evaluation Plan to PSUR — with 8 editable Word templates aligned to the latest MDCG guidance. Or buy only the template you need.
EU MDR Documentation Kit
Everything you need to face Notified Body submission and post-market obligations under EU MDR. 8 professionally drafted Word templates covering Clinical Evaluation (CEP/CER/CDP), Post-Market Surveillance (PMS Plan, PSUR), Post-Market Clinical Follow-up (PMCF Plan and Evaluation Report) and Summary of Safety and Clinical Performance (SSCP) for Class III and implantable devices.
Each template is professionally drafted, fully editable in Word and ready to integrate with your technical documentation.
Filter by lifecycle phase or MDR article:
Word template aligned with Article 61 and Annex XIV Part A. Includes PICO framework, equivalence criteria (technical/biological/clinical), state-of-the-art search protocol, GSPR mapping. References MDCG 2020-5, 2020-6, 2020-13.
Word template aligned with Article 61 and Annex XIV Part A. Includes Executive Summary, preclinical evidence, state-of-the-art analysis, GSPR conformity assessment, benefit-risk analysis. Companion to the CEP and structured for Notified Body review.
Word template per Annex XIV Part A. Defines residual clinical uncertainties, GSPR cluster conformity status, planned clinical investigations, registry participation and real-world data strategy. Critical for Class III and implantables.
Word template aligned with Article 83-84 and Annex III §1.1. Includes proactive and reactive data inputs, quantitative indicators, trend analysis methods, vigilance reportability decisions, FSCA process and Article 88 trend reporting.
Word template aligned with Article 86. Includes production volume and population analysis, status of previous PSUR actions, risk-benefit analysis based on post-market data, serious incidents and FSCAs. Every 2 years for Class IIa, annual for Class IIb and III.
Word template aligned with Article 61(11) and Annex XIV Part B. Includes activity programme (literature monitoring, surveys, registries, RWD, PMCF studies), method justification, acceptance criteria, threshold triggers and action logic. References MDCG 2020-7.
Word template per Annex XIV Part B. Documents activities executed vs planned, results by source (literature, vigilance, complaints, surveys, registries, RWD), integrated analysis vs acceptance thresholds and impact on benefit-risk ratio. References MDCG 2020-8.
Word template aligned with Article 32 for Class III and implantable devices. Includes professional and lay sections, device identification, residual risks, intended clinical benefits, summary of clinical evaluation and PMCF, suggested profile for Eudamed publication.
Each template is mapped to the relevant MDR articles, annexes and Medical Device Coordination Group guidance documents.
| Template | MDR Reference | MDCG Guidance | When to produce |
|---|---|---|---|
| CEP | Art. 61 + Annex XIV-A | MDCG 2020-5, 2020-6, 2020-13 | Before clinical development |
| CER | Art. 61 + Annex XIV-A | MDCG 2020-13, 2020-1, 2024-10 | Pre-market & ongoing updates |
| CDP | Annex XIV-A | MDCG 2020-5, 2020-6 | Before clinical development |
| PMS Plan | Art. 83-84 + Annex III §1.1 | MDCG 2022-21 | Pre-market, maintained ongoing |
| PSUR | Art. 86 | MDCG 2022-21 | Every 2 years (Class IIa) / annual (Class IIb-III) |
| PMCF Plan | Art. 61(11) + Annex XIV-B | MDCG 2020-7 | Pre-market |
| PMCF Eval. Report | Annex XIV-B | MDCG 2020-8 | Periodically over device lifecycle |
| SSCP | Art. 32 | MDCG 2019-9 Rev. 1 | Class III & implantables, Eudamed |
The templates provide the complete structure, methodology and required content sections expected by Notified Bodies. You must populate them with your device-specific data, clinical evidence, equivalence justification and benefit-risk analysis. They are professional starting points designed to align with NB review expectations — not a substitute for clinical and regulatory expertise.
The CEP, CER, CDP, PMS Plan, PMCF Plan, PMCF Evaluation Report and PSUR are applicable to all MDR risk classes (I, IIa, IIb, III). The SSCP is required only for Class III and implantable devices per Article 32. The PSUR frequency depends on class (every 2 years for Class IIa, annual for Class IIb and III) per Article 86.
Yes. The CEP and CER explicitly address sufficient clinical evidence for legacy devices (MDCG 2020-6) and the equivalence criteria under Annex XIV Part A §3 (technical, biological and clinical), including the contractual data-access requirement applicable for Class III equivalence claims under Article 61(5).
All 8 templates are delivered as Microsoft Word .docx files, fully editable. The kit also includes a Master Index spreadsheet (Excel) with cross-references between templates and a README with usage instructions and update frequency guidance.
You will receive lifetime access to the kit. When MDCG publishes new guidance or significant MDR amendments are released, registered customers receive update notifications via email with revised templates at no additional cost.
The kit is licensed for internal use within your organisation across multiple device families and projects. Internal team members can use and adapt the templates. Redistribution outside your organisation or reselling is not permitted.
Yes. For complex projects (CER drafting, equivalence assessments, PMCF study design, NB audit preparation) we offer dedicated consulting services. Contact us through the consulting page.
Buying the 8 templates individually costs €552. Get all 8 templates + Master Index + README for €399.
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