MDR expects a coherent, navigable evidence pack, not a folder of disconnected Word files. Whether you are migrating an MDD-era file or tightening an existing MDR pack, the goal is the same: a technical file a Notified Body can follow from intended purpose through to post-market evidence.

What is an EU MDR technical file?

An EU MDR technical file is the structured evidence pack that shows how a medical device meets the applicable requirements of Regulation (EU) 2017/745. Reviewers typically expect a clear device description, design and manufacturing information, labelling, risk management, clinical evaluation, verification and validation, and post-market plans, organised so that a Notified Body can navigate them.

What the technical file means in practice

For SME manufacturers, the technical file is the living pack used alongside your quality system when you seek or maintain CE marking under the MDR. It is evidence your organisation owns, not a certificate a software tool can issue. It has to stay current for the lifetime of the device, which is why structure matters as much as content. Our guide to identifying gaps and maintaining readiness covers the ongoing side in more detail.

High-level structure (Annex II and III)

Exact obligations depend on device class, conformity assessment route and the official text, so always confirm against the EU MDR and your advisors. The building blocks teams usually organise are:

• Device identity and intended purpose

• Design and manufacture

• Labelling and instructions for use

• GSPR and requirements mapping

• Risk management

• Clinical evaluation

• Verification and validation

• Post-market surveillance (PMS, PMCF and vigilance as applicable)

• Conformity artefacts and the Declaration of Conformity

• Dossier assembly for review

Migrating an MDD technical file to MDR

Many manufacturers still hold technical files written for the Medical Device Directive. Migrating them to MDR usually means:

• Restructuring evidence for GSPR mapping

• Deepening the clinical evaluation and PMS plans

• Closing traceability breaks between risk, clinical and verification and validation evidence

• Keeping one workspace so migration does not fork into drifting Word and SharePoint copies

Transition deadlines for legacy devices are fixed, so it pays to plan early. See MDR and IVDR transition deadlines for the dates that apply.

Technical file management vs QMS

A technical file and a quality management system are related but different. Your QMS (procedures, document control, CAPA, training) remains yours. Obodux focuses on building and maintaining the technical file evidence pack beside your ISO 13485 processes. It does not replace ISO 13485.

How Obodux helps

• A structured technical file workspace organised around MDR building blocks

• AI-assisted drafting from your device context (guidance only, your team reviews and owns the content)

• Optional review by regulatory specialists

• A free gap analysis to show what is missing, incomplete or still aligned to the old directives

Who this is for

UK and EU SME medical device manufacturers, and RA/QA or founder leads who are mid-MDR transition, facing Notified Body rework, or planning an MDD to MDR technical file migration. If you also place devices on the UK market, read our guide to UKCA technical documentation.

Request a free gap analysis or start a 4-week free trial of Obodux.

Obodux is a documentation aid provided by BORIS Software Ltd. It is not legal or regulatory advice and does not guarantee CE marking, Notified Body acceptance or any regulatory approval. Annex II and III references are high-level and informational; confirm against the current official EU MDR text and your qualified advisors.