EU MDR

EU MDR technical documentation checklist

Generate a structured Technical File checklist based on your device class and key characteristics. Includes Annex II technical documentation sections and Annex III PMS documentation. Planning tool only.

Calculator

Start with three inputs, then adjust advanced options if needed.

Device class
Include Class I variants (Is/Im/Ir) when applicable.
Device type
Software devices have additional evidence expectations.
Implantable
Implantable devices often trigger SSCP expectations.
Advanced options
Clinical investigation planned or likely
Clinical data from equivalence
Required files for device class IIa
24 items
Required PMS documentation (Annex III)
  • PMS plan
  • PSUR (Class IIa/IIb/III)
Extra deliverables flagged for your case
  • Review clinical investigation need for the clinical evidence plan
  • Confirm equivalence strategy and data access
Required Technical File sections (Annex II)
1. Device description and specification
  • Intended purpose, indications, and target population
  • Basic UDI-DI and device variants/accessories
  • Classification rule rationale
  • Previous generations and similar devices
2. Information supplied by the manufacturer
  • Labels, IFU, and packaging information
  • Marketing materials and claims
  • Translations and symbol lists
3. Design and manufacturing information
  • Design stages, drawings, and BOM
  • Manufacturing processes and controls
  • Critical suppliers and outsourced processes
4. General Safety and Performance Requirements (GSPR)
  • GSPR checklist or matrix
  • Applicable standards and common specifications
  • Justifications for non-applicable requirements
5. Benefit-risk analysis and risk management
  • Risk management file summary
  • Benefit-risk analysis and residual risk rationale
  • Risk control measures and verification
6. Product verification and validation
  • Preclinical testing and performance data
  • Biocompatibility and safety testing
  • Clinical evaluation report and evidence
  • Software verification and validation (if applicable)
Submission readiness checklist
  • Create GSPR checklist with evidence references
  • Finalize device description, intended purpose, and classification rationale
  • Complete risk management file and benefit-risk summary
  • Assemble verification and validation reports
  • Finalize clinical evaluation and clinical evidence package
  • Complete labeling, IFU, and packaging evidence
  • Prepare PMS plan and update cadence
  • Prepare PSUR or PMS report as required
  • Confirm traceability between requirements, tests, and evidence
  • Review for missing sections and unresolved gaps
Best-practice submission structure

Keep Annex II and Annex III evidence tightly cross-referenced to reduce review questions. A clean structure with traceability reduces Notified Body review cycles.

Disclaimer: Planning tool only. This checklist maps MDR Annex II and Annex III structure and does not replace Notified Body advice.
Methodology and sources

Summary of the Annex II and Annex III mapping logic and the sources behind it. Open to see details and links.

This calculator maps your inputs to the required Technical File elements defined in MDR Annex II and Annex III.

It flags PMS outputs like the PMS report (Class I) and PSUR (Class IIa/IIb/III) based on MDR articles.

It adds best-practice submission structure notes informed by Notified Body guidance, because poor structure is a predictable source of review cycles.

Regulation (EU) 2017/745 full text (Annex II, Annex III, PMS and PSUR articles). EUR-Lex MDR

Team-NB best practice guidance for Annex II/III submissions (V3). Team-NB position paper

MDCG endorsed documents index. MDCG guidance index

MDCG 2020-1 software clinical evaluation guidance. MDCG 2020-1

How AI Gap Analysis reduces cost and timeline risk

Most delays and cost blowups come from missing sections, weak traceability, or evidence that is hard to locate. AI Gap Analysis turns your current PDFs into:

  • A clause-by-clause gap list (what is missing)
  • Evidence map with citations and page links (what proves it)
  • Recommendations you can turn into tasks

Generate an evidence-ready Annex II checklist from your existing PDFs

Upload your Technical File and QMS docs. Get a checklist with page-linked evidence and gaps to fix before submission.

Run a gap analysis on your docs

FAQ

Does this replace Notified Body advice?

No. It is a planning checklist based on MDR Annex II/III. Your Notified Body may request additional device-specific detail.

Why do I still need Annex III if we are early stage?

The PMS plan is part of the technical documentation set and drives what you will maintain post-market.

Do all devices need a PSUR?

No. Class I uses a PMS report; Class IIa/IIb/III uses a PSUR.

What if we are software (SaMD)?

Software follows the same MDR structure, but clinical and performance evidence expectations often need extra care; we link to MDCG software clinical evaluation guidance.