6 common mistakes in MDR technical documentation (and how to avoid them)

Creating technical documentation for MDR compliance can be challenging. Although many manufacturers believe they meet all the requirements, issues still arise during assessments. These issues often lead to delays or rejections. Therefore, understanding the most frequent mistakes is essential for a successful submission.

1. Weak scientific justification

One frequent problem is the failure to provide a clear rationale for conformity with the General Safety and Performance Requirements (GSPR). For example, some files lack references to relevant standards or fail to link clinical data to device performance. In many cases, the explanation does not reflect a scientific approach.

Tip: Clearly support every claim with traceable, evidence-based documentation. In addition, reference harmonized standards where applicable and ensure consistency with the intended purpose and risk classification.

2. Incomplete or vague device definition

Another common issue occurs when the description of the device is unclear. Often, the documentation does not explain variants, configurations, or accessories in enough detail. As a result, reviewers may struggle to understand what exactly is covered.

Tip: Provide a detailed and structured description. Include configuration tables, visual diagrams, and precise naming conventions to define the scope of the file clearly.

3. Risk analysis not aligned with clinical use

Risk management reports sometimes fail to reflect real-world scenarios. Consequently, they may contradict clinical findings or overlook critical hazards. This disconnect reduces the credibility of the entire documentation.

Tip: Align your risk analysis with actual clinical conditions and supporting data. Furthermore, link each identified risk to mitigation strategies and post-market follow-up activities.

4. Inadequate clinical strategy

Several submissions rely too heavily on claimed equivalence or lack a well-developed Post-Market Clinical Follow-up (PMCF) plan. This significantly weakens the clinical evaluation section.

Tip: Use robust and specific clinical evidence. If you claim equivalence, make sure you have full access to the comparator data and demonstrate similarity from a technical, biological, and clinical standpoint.

5. Gaps in verification and validation testing

Many technical files present test results without proper explanation. For instance, some reports do not include test conditions, sample details, or clear criteria for success. This makes it harder to verify the reliability of the results.

Tip: Present comprehensive reports or structured summaries. Always mention the device configuration, environment, and standards used for each test.

6. Poorly structured GSPR checklist

Lastly, many checklists are outdated or too general. Some do not link requirements to actual evidence. In contrast, a well-prepared checklist improves traceability and speeds up the review process.

Tip: Create a GSPR table that connects each requirement to specific documents, including version numbers and page references. This enhances transparency and supports your claims effectively.

Conclusion

Technical documentation plays a crucial role in MDR conformity. However, recurring errors often slow down the review. By focusing on these six areas, you can make your file more consistent, clearer, and easier to evaluate. As a result, you will improve your chances of obtaining approval on the first attempt.