MDR technical documentation: what Annexes II and III require

Technical documentation is the file that demonstrates a medical device meets the MDR requirements. It is what the notified body assesses and what the competent authority may request at any time. MDR Annexes II and III set its content; this guide details them.

What technical documentation is for

MDR Article 10(4) requires the manufacturer to draw up and keep up to date technical documentation that allows the device's conformity to be assessed. It must be:

• complete: every required element is present or its absence is justified;
• structured and readily searchable: Annex II requires a clear, organised and unambiguous presentation;
• up to date: it follows changes to the device, standards and surveillance data;
• kept for at least 10 years after the last device covered by the EU declaration of conformity is placed on the market, 15 years for implantables (Article 10(8)).

Annex II: the six parts

1. Device description and specifications

• Trade name, general description, intended purpose, intended users
• Basic UDI-DI assigned by the manufacturer
• Patient population, indications, contraindications, warnings
• Principles of operation and mode of action
• Rationale for qualifying the product as a medical device
• Risk class and classification rule applied (Annex VIII)
• Novel features, accessories, variants and configurations
• Key components, materials in contact with the body, technical specifications
• References to previous generations and similar devices on the market

2. Information supplied by the manufacturer

Labels on the device and its packaging, and instructions for use, in the languages of the Member States where the device will be sold.

3. Design and manufacturing information

Design stages, manufacturing processes and their validation, continuous monitoring and final testing, and identification of all sites where design and manufacturing take place, including critical subcontractors and suppliers.

4. General safety and performance requirements

A requirement-by-requirement demonstration of conformity with Annex I:

• the applicable requirements, and justification for those that do not apply;
• the method used to demonstrate conformity;
• the harmonised standards, common specifications or other solutions applied;
• the precise reference to the documents providing the evidence.

This checklist is often the notified body's entry point into the assessment.

5. Benefit-risk analysis and risk management

The benefit-risk analysis and the solutions adopted, with the results of risk management under Annex I, usually based on ISO 14971.

6. Product verification and validation

Pre-clinical and clinical data:

• results of engineering, laboratory, simulated-use and, where applicable, animal tests;
• biocompatibility, electrical safety and electromagnetic compatibility;
• software verification and validation;
• stability and shelf life;
• clinical evaluation report and post-market clinical follow-up (PMCF) plan, or justification for its absence.

Additional information in specific cases: incorporated medicinal substance, tissues or cells of human or animal origin, substances absorbed by the body, CMR or endocrine-disrupting substances, sterile devices, measuring function, connection to other devices.

Annex III: post-market surveillance

The technical documentation also includes:

• the post-market surveillance plan (Article 84), with its data sources, indicators and thresholds, and the PMCF plan;
• the PSUR (classes IIa, IIb and III) or the post-market surveillance report (class I).

Our guide on post-market surveillance covers them in detail.

What the notified body assesses

Class	Technical documentation assessment
IIa	On a representative sample, per category of devices
Non-implantable IIb	On a representative sample, per generic device group
Implantable IIb and III	For each device

Language and access

The documentation is written in a language accepted by the notified body. The competent authority may request it, in full or in part, in an official EU language it determines. For a manufacturer established outside the EU, the authorised representative keeps a copy available to authorities.

Frequent findings

1. A GSPR checklist without precise references to the evidence.
2. An inconsistent intended purpose between the description, the instructions and the clinical evaluation.
3. Standards cited in an outdated version, with no gap analysis against the current version.
4. Manufacturing sites or critical subcontractors not identified.
5. Documentation that does not follow device changes or PSUR conclusions.

Technical documentation ages with standards and MDCG guidance: keeping it current requires organised medical device regulatory monitoring.