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Technical documentation — overview

Regulatory basis

MDR 2017/745, Annex II (technical documentation) and Annex III (technical documentation on post-market surveillance). Equivalent provisions in IVDR 2017/746, Annex II and III. Technical documentation must be compiled before CE marking and maintained throughout the device lifecycle.

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

What is technical documentation?​

Technical documentation (TD) is the comprehensive body of evidence that demonstrates a device meets all applicable MDR or IVDR requirements. It is the manufacturer's "proof file" — not submitted routinely to regulators, but held by the manufacturer and made available to notified bodies and competent authorities on request.

Technical documentation is not a single document — it is a structured collection of documents, test reports, analyses, clinical evidence, and processes that together demonstrate conformity.

Two Annexes — Pre-market and Post-market​

MDR and IVDR split technical documentation across two annexes:

AnnexContentWhen compiled
Annex IIPre-market technical documentation — device description, GSPR, design, manufacturing, risk management, clinical/performance evidenceBefore CE marking; updated as device changes
Annex IIIPost-market technical documentation — PMS plan, PMS reports, PSUR, PMCF/PMPF plan and evaluation reportsOngoing throughout the device lifecycle

Annex II — Structure and content​

MDR Annex II requires the following sections:

1. Device description and specification​

  • Device name, model, and reference numbers
  • Intended purpose (full statement)
  • Intended patient population, indications, and contraindications
  • Functional description of how the device works
  • Novelty and comparison with previous generation or equivalent devices

See Device description & specification.

2. Information to be supplied by the manufacturer​

Copies of labelling and instructions for use (as per GSPR Chapter III). Applies to all language versions.

3. Design and manufacturing information​

  • Design stages and design changes
  • Manufacturing sites and processes
  • Critical components and sub-assemblies
  • Sterilisation methods (if applicable)

See Design & manufacturing information.

4. General safety and performance requirements (GSPR)​

The GSPR cross-reference table — mapping each applicable GSPR to the evidence of compliance.

See GSPR cross-reference.

5. Benefit-risk analysis and risk management​

The risk management file (or reference to it). Summary of the benefit-risk assessment.

See Risk management.

6. Verification and validation​

Results of tests, studies, and analyses demonstrating the device meets its specifications and the GSPR. Includes:

  • Functional and performance testing
  • Biocompatibility testing
  • Electrical safety and EMC testing (if applicable)
  • Software verification and validation
  • Sterility and stability testing
  • Usability testing (if applicable)
  • Pre-clinical studies (animal studies, bench testing)

7. Clinical evaluation report (MDR) / Performance evaluation report (IVDR)​

A full clinical or performance evaluation demonstrating the device's safety and performance in clinical use.

See Clinical evaluation and Performance evaluation.

Annex III — Post-market technical documentation​

Annex III requires:

1. Post-market surveillance plan (PMS plan)​

A proactive plan for collecting post-market data. Must be updated at least annually.

2. Post-market surveillance reports (PMS reports / PSURs)​

  • Class I / IIa / IIb: PMS report
  • Class IIb (implantable), III, AIMD: Periodic Safety Update Report (PSUR), at minimum annually
  • IVDR Class C, D: PSUR

3. PMCF/PMPF plan and evaluation report​

  • MDR: Post-Market Clinical Follow-up (PMCF) plan and evaluation report
  • IVDR: Post-Market Performance Follow-up (PMPF) plan and evaluation report

See Post-market data in technical documentation.

Who must compile technical documentation?​

The manufacturer is responsible for compiling and maintaining technical documentation, even if parts of it (e.g. biocompatibility testing, clinical evaluation) are performed by third parties.

For devices manufactured outside the EU, the authorised representative (EU REP) does not compile TD but must ensure the manufacturer has done so and that it is accessible.

Technical documentation vs. design history file​

Manufacturers familiar with FDA terminology may ask how EU technical documentation compares to the Design History File (DHF) and Device Master Record (DMR). The comparison is approximate:

EU conceptClosest FDA equivalent
Annex II Technical DocumentationDesign History File (DHF) + Device Master Record (DMR) + Risk Management File
Annex III PMS Technical DocumentationPost-Market Surveillance File
Clinical Evaluation ReportClinical/Performance Summary

EU technical documentation requirements are generally more prescriptive about the clinical evidence component (CER) than FDA's equivalent documentation requirements.

Maintenance obligations​

Technical documentation must be:

  • Kept current — updated whenever the device changes (design, materials, manufacturing, labelling) and when post-market data triggers a need for review
  • Retained for at least 15 years after the last device was placed on the market (30 years for implantable devices)
  • Made available to competent authorities and notified bodies on request within a defined timeframe
  • Held at the manufacturer's registered place of business or accessible from it

Official references​

ReferenceDescription
MDR Annex IITechnical documentation (pre-market)
MDR Annex IIITechnical documentation on PMS
IVDR Annex IIIVDR technical documentation
IVDR Annex IIIIVDR PMS technical documentation
MDR Art. 10(8)Retention period for technical documentation
MDCG 2019-9Summary of safety and clinical performance (SSCP)
MDCG 2020-6Guidance on templates for technical documentation