How does device classification affect the technical file?

The higher the class, the deeper the scrutiny. For every class above Class I a Notified Body reviews your technical documentation as part of conformity assessment, and for the highest-risk devices that includes a detailed design-dossier examination. Class also drives how much clinical evidence is expected.

Does the technical documentation need to be kept up to date?

Yes. The MDR requires technical documentation to be clear, organised, readily searchable and continuously updated across the device lifecycle, reflecting design changes, new clinical data and post-market surveillance findings.

MDR Technical Documentation

The EU Medical Device Regulation (MDR 2017/745) requires every manufacturer to compile technical documentation that shows the device conforms to the regulation to ensure safety. Its contents are defined in Annex II (the technical file) and Annex III (post-market surveillance), and it has to be clear, organised, readily searchable and kept up to date throughout the device lifecycle.

What must MDR technical documentation include?

Annex II sets out the core technical file. At a high level it covers:

Device description and specification: including variants, intended purpose and intended users.
Information supplied by the manufacturer: labelling and instructions for use.
Design and manufacturing information: how the device is designed and produced.
General Safety and Performance Requirements (GSPR): the Annex I checklist, with evidence of how each applicable requirement is met.
Benefit-risk analysis and risk management, following your risk-management process.
Product verification and validation: including the clinical evaluation (Annex XIV) and, for software, verification and validation work.

What is the difference between Annex II and Annex III?

Annex II is the technical documentation that demonstrates conformity. Annex III is the post-market surveillance documentation: the PMS plan, the periodic safety update report (PSUR) and post-market clinical follow-up (PMCF). Between them they cover the device from its design through to its life on the market.

How does classification affect the documentation?

The depth of scrutiny scales with risk class. For every class above Class I, a Notified Body reviews the technical documentation during conformity assessment. If you are not yet sure of your class, start with our MDR classification guide, or the SaMD classification guide if your device is software.

Frequently asked questions

What must MDR technical documentation include?: Annex II of the MDR requires a device description and specification, the information supplied by the manufacturer (labelling and instructions for use), design and manufacturing information, the General Safety and Performance Requirements (GSPR, Annex I) with evidence of conformity, the benefit-risk analysis and risk management, and product verification and validation including the clinical evaluation. Annex III adds the post-market surveillance documentation.
What is the difference between Annex II and Annex III?: Annex II is the core technical documentation that shows the device conforms to the MDR. Annex III is the technical documentation on post-market surveillance: the PMS plan, the periodic safety update report (PSUR) and post-market clinical follow-up (PMCF). Both have to be kept current throughout the device lifecycle.
How does device classification affect the technical file?: The higher the class, the deeper the scrutiny. For every class above Class I a Notified Body reviews your technical documentation as part of conformity assessment, and for the highest-risk devices that includes a detailed design-dossier examination. Class also drives how much clinical evidence is expected.
Does the technical documentation need to be kept up to date?: Yes. The MDR requires technical documentation to be clear, organised, readily searchable and continuously updated across the device lifecycle, reflecting design changes, new clinical data and post-market surveillance findings.

This page is preparatory guidance based on MDR 2017/745, not legal advice. Your technical documentation is ultimately assessed by your Notified Body during conformity assessment.

Turn the Annex II checklist into a plan for your device

Health Tech Pathways breaks the technical documentation into structured, guided steps mapped to your device's classification, with a free assessment to get you started.