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EU MDR technical documentation

The file a notified body assesses before a medical device is CE marked, set out in Annex II and Annex III of the MDR.

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What is the EU MDR technical documentation?

The technical documentation is the file a manufacturer compiles to show a medical device meets the general safety and performance requirements of the EU MDR. Annex II sets its contents, from device description to clinical evaluation, and Annex III adds the post-market surveillance documentation. For Class IIa and above a notified body assesses it before the CE mark goes on.

The manufacturer keeps the file current for as long as the device is on the market, and available to the competent authority for at least ten years after the last device is placed on it, fifteen for implantables.

Who needs the technical documentation?

Every manufacturer placing a medical device on the EU market, of any class. A Class I manufacturer compiles it and holds it for the competent authority; for Class IIa and above a notified body assesses it

Manufacturers of Class III and implantable Class IIb devices, whose file the notified body assesses in full for every device, where the file for other classes is assessed on a sample

Manufacturers of legacy devices on MDD or AIMDD certificates, who have until the end of 2027 or 2028 to put the file through MDR conformity assessment

The work starts when the notified body sends its review date, when the clinical evaluation update is due and the risk file has moved on, or when a design change lands and someone has to decide whether the certificate still covers it.

What the technical documentation contains

Annex II sets the file's structure and Annex III adds the post-market part. Every section is a document or a set of results your team produces and signs, and the notified body reads each against Annex I.

Device description and specification

What the device is and does, its variants and accessories, the Basic UDI-DI and the previous and similar generations it descends from

Information supplied by the manufacturer

The label, the packaging and the instructions for use, in the languages of the markets it is sold in

Design and manufacturing information

The design stages, the manufacturing process and its controls, and every site involved, including suppliers and subcontractors

General safety and performance requirements

Each requirement in Annex I, whether it applies, the method used to show it is met, the harmonised standard or common specification applied and the document that holds the evidence

Benefit-risk analysis and risk management

The risk management file, with the residual risks weighed against the clinical benefit

Product verification and validation

The pre-clinical and clinical data, the clinical evaluation report with the post-market clinical follow-up plan and its evaluation report behind it, and for software the verification and validation of the software lifecycle, with biocompatibility, sterilisation, shelf life and electrical safety where the device calls for them

Post-market surveillance documentation (Annex III)

The PMS plan with the post-market clinical follow-up plan inside it, and the PSUR for Class IIa and above or the PMS report for Class I

How the technical documentation is assessed

1. Classify the device under Annex VIII

And choose the conformity assessment route. The class decides whether a notified body assesses the file, and whether it reads every file or a sample.

2. Build the design controls and the clinical evaluation

Requirements, the risk management file, verification and validation and the clinical evaluation plan, with each result signed and traceable to the requirement in Annex I it answers.

3. Compile the file in the Annex II and III structure

With every document at its signed version and the GSPR checklist pointing at the evidence for each requirement.

4. Notified body review

The reviewer reads the file against Annex I and the clinical evidence against Article 61, raises questions and asks for more evidence where it is thin, then issues the certificate or a list of nonconformities to close first.

5. CE mark, and keep the file current

The manufacturer signs the declaration of conformity and affixes the CE mark. Every design change after that is assessed against the file, and the PSUR, the PMCF evaluation report and the clinical evaluation update go into it on the regulation's cycle.

THE EU MDR TECHNICAL DOCUMENTATION IN QUALIO

Qualio compiles the technical documentation from the design controls your approvers signed, in the Annex II structure the notified body reads

Qualio holds the requirements, the ISO 14971 risk file and the verification and validation results, read from Jira and TestRail as your engineers work, and rebuilds the traceability as the work changes. When the review date lands, it compiles the technical documentation from the signed versions, laid out in the annex's own sections. The file is kept with its approvals, so the next version starts from the last.

The ISO 14971 risk management report inside the file at its signed version, with every hazard traced to its control and the test that verifies it

A design change assessed against the CE marked file, so the decision on whether the certificate still covers it is made in the change control, dated and signed

The organisation-level EU MDR framework in the same library, so the quality system the notified body audits and the file it assesses are read together. See EU MDR

Standards that apply alongside the technical documentation

Medical devicesEU MDR
The regulation as a whole, and the quality management system under Article 10 that the same notified body audits at the initial and surveillance audits
Medical devicesISO 14971
The risk management file the benefit-risk section comes from, from hazard to residual risk, harmonised under the MDR
Medical devicesIEC 62304
The software lifecycle behind the software verification and validation section, for devices that are or contain software
Medical devicesISO 13485
The quality management system standard the design controls run under, and the harmonised standard for Article 10
Product submissionsFDA 510(k)
The US equivalent route to market, with its submission compiled from the same design controls for an FDA reviewer

Effectum Medical

Effectum Medical wanted a best-in-class quality system for themselves, and also to share with their medical device clients to guide them to market. Here's what they did.

Read the Effectum Medical story

“We now have a consolidated device file which reflects the development of our product. 18 months ago, we didn't have anything like that.”

Phil CooleyPhil CooleyQuality Manager, Bond Digital Health

Guides and checklists for the EU MDR technical documentation

Checklist

EU MDR general safety and performance requirements (GSPR) checklist

Guide

CE marking pathway guide

Guide

Medical device classification guide

Questions about the EU MDR technical documentation

What is the EU MDR technical documentation?

The technical documentation is the file a manufacturer compiles to show a medical device meets the general safety and performance requirements of the EU MDR. Annex II sets out its contents, from the device description and labelling through design, risk management and clinical evaluation, and Annex III adds the post-market surveillance plan and reports. A notified body assesses it before the CE mark goes on.

What is the difference between the technical documentation and the quality management system?

The technical documentation is about one device: the evidence that it meets Annex I. The quality management system under Article 10 is about the manufacturer: the procedures for design, risk, complaints, vigilance and post-market surveillance that produced that evidence. The notified body assesses the first and audits the second, and the certificates it issues cover both. See EU MDR.

Does a notified body review the technical documentation for every device?

For Class III and implantable Class IIb devices, yes, every file in full. For other Class IIb and Class IIa devices the notified body assesses the file for a representative sample of devices and covers the rest over the certificate's life. Class I manufacturers hold the file for the competent authority and no notified body reads it, except for sterile, measuring and reusable surgical devices.

What is the GSPR checklist?

A table of every general safety and performance requirement in Annex I, with whether it applies to the device, the method used to show it is met, the harmonised standard or common specification followed, and the document in the technical documentation that holds the evidence. It is the index the notified body reads first, and it has to point at documents that exist at the version cited.

How long must the technical documentation be kept?

For at least ten years after the last device covered by the declaration of conformity is placed on the market, and fifteen years for implantable devices, with the declaration and any certificates kept with it. It has to be available to the competent authority on request throughout, and kept current for as long as the device is sold.

Does a design change mean the technical documentation has to be reassessed?

Yes, by the manufacturer every time. A substantial change to the quality system or device range (Annex IX 2.4), or a change to the device that could affect its safety, performance or conditions of use (Annex IX 4.10), goes to the notified body before it is made. Other changes are recorded in the file with the reasoning.

Can we build the technical documentation from the design controls we already run in Qualio?

Yes. The EU MDR technical documentation framework in Qualio maps the Annex II and III sections to the requirements, risk file, tests and documents you already hold, compiles the file from their signed versions and exports it laid out in the annex's own sections. The file is kept with its approvals, so the next version and the next PSUR cycle start from it.

When is the file due?

Bring the date and your design controls, wherever they live. We will show you the file compiled from them in the annex's own sections, with the approval behind every document.

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