A medical device manufacturer can have hundreds of documents and still struggle to answer a simple question: are we ready for assessment?

The starting point

The drawings exist. Testing has been completed. There is a risk assessment, a clinical evaluation report and a folder containing instructions for use. But do they describe the same version of the device? Can each relevant requirement be traced to supporting evidence? And what might still be missing?

What readiness means under the MDR

The MDR requires technical documentation to be clear, organised, readily searchable and unambiguous. Annexes II and III set out requirements for its content, including documentation on post-market surveillance. Organisation is therefore part of how a manufacturer demonstrates compliance. For an overview of the structure, see EU MDR Technical File: Structure It Once, Maintain It Properly.

Three things to examine

Completeness

Have you addressed the requirements applicable to your device?

Consistency

Do the documents agree on the device, its intended purpose and its characteristics?

Traceability

Can someone follow a requirement or claim through to the evidence supporting it?

A document can be present without containing sufficient evidence.

Finding the gaps you do not know about

Teams can plan for work they recognise. They can schedule a test, update a report or assign someone to review a requirement. Work becomes harder to manage when nobody has identified that it is needed. Obodux co-founder and medical device practitioner Simon Taylor calls these the "unknown unknowns", and explains more in The gaps you can't see.

Making the evidence connections visible

The documentation should make the connections between these elements easy to follow and traceable throughout:

1. User need

2. Design requirement

3. Design output

4. Verification evidence

5. Validation evidence

When those relationships are recorded clearly, the team has a practical starting point for assessment.

Keeping shared information consistent

Shared information, such as intended purpose, intended users and patient population, can appear in several parts of a technical file. If teams maintain each description separately, a change can leave conflicting versions behind. A useful discipline is to maintain shared information in one source of truth, and to identify who approves changes and where those changes need to be reflected.

Maintaining readiness after market entry

Complaints, user feedback, new literature and device changes can prompt further assessment. All technical documentation, not just the clinical evaluation, needs to be maintained and always audit-ready throughout the lifetime of the device, using all relevant post-market information (EU MDR, Article 10 and Annexes II and III).

Four questions to ask about your technical file

1. Can we identify the device configuration and intended purpose covered by each key report?

2. Can we trace applicable safety and performance requirements to supporting evidence?

3. Have we distinguished missing documents from insufficient evidence?

4. Can we show how relevant changes and post-market findings have been assessed?

A practical starting point

Consultant-led gap analyses can cost £3,000–£8,000 per technical file, depending on scope. Obodux offers its gap analysis free. Request a free Obodux gap analysis or start a 4-week free trial of Obodux.

Regulatory responsibility remains with the manufacturer.