MDR Technical Documentation: Drawing on BSI Best Practices to Build a Robust and Agile File

August 2026 – Initially published on LinkedIn and expanded for the website

BSI, one of the leading European notified bodies for medical devices, has published an update of its best practice guidelines for MDR technical documentation submission now including a dedicated section on devices incorporating artificial intelligence or machine learning. A useful reference document that clarifies what evaluators concretely expect when reviewing a technical file.

A subject that affects a wide range of profiles

Technical documentation remains one of the most frequent pain points for manufacturers targeting the European market. Through my missions, I have supported very different profiles on this subject:

• US and Canadian companies pursuing their first CE marking,
• More established companies developing an innovative device,
• Companies seeking to conduct clinical investigations in France, and
• Startups in the process of structuring their regulatory approach.

These situations share a common thread: gaps in technical documentation that, if not identified early, generate additional delays, unexpected costs, and a postponement of patient access to the clinical solutions concerned.

The most frequently identified gaps

Among the errors observed in the field, several come up regularly:

• A clinical strategy that does not account for the relevant endpoints to demonstrate safety and performance for the intended CE indication, nor the alternatives already available on the market.
• A file built around FDA or Health Canada requirements, without transposition to MDR requirements — a frequent situation for North American companies approaching the European market for the first time.
• Verification data based on an early product version, without a bridging study or justification of applicability for the final product subject to CE marking.
• Risk management documentation that does not demonstrate compliance with ISO 14971 and EN 62366 requirements, nor the integration of state-of-the-art data and verification and validation data.
• Stability studies that do not integrate safety and performance data.
• Insufficient design history to justify the expected clinical benefit and the verification and validation data included.
• A GSPR checklist that does not demonstrate that these requirements were addressed during design and development (§7.3, ISO 13485).

Class I device manufacturers are equally concerned

MDR technical documentation is not only relevant for manufacturers whose file is assessed by a notified body as part of the conformity assessment process. Class I device manufacturers who self-certify, have equally good reason to draw on these best practices.

Regular reviews of technical documentation make it possible to verify that it is properly aligned with the design and development process and with change management, and that it accurately reflects the current state of the product. It is an essential readiness in the event of an inspection by a competent authority.

This consideration takes on an additional dimension for manufacturers with large product ranges and multiple similar references. Building a technical documentation architecture that is compliant, optimised and agile — meaning easy to update following a change, a corrective action, a vigilance event or a post-market surveillance update — is an investment that facilitates every interaction with authorities and every evolution of the file over time. BSI’s guidelines provide a useful framework in this context for formalising this architecture effectively, without compromising compliance and while maintaining the traceability required.

→ Would you like to verify the robustness of your technical documentation or identify the adjustments needed before a submission or audit? The One Health Compliance Project Audit is designed for exactly this: a structured analysis of your file, a prioritised action plan, and concrete recommendations to move forward.

Sandra Dejean, PharmD – Founder of One Health Compliance

References:

• BSI. MDR Documentation Submission – Best Practice Guidelines. 2026 : https://www.bsigroup.com/en-GB/insights-and-media/insights/brochures/mdr-documentation-submission
• Dejean S. Regulatory Watch: EU Technical Documentation for CE Marking. Linkedin, August 2026. [Online]. Available at: https://www.linkedin.com/feed/Regulatorywatch-EU-technical-documentation.
• © Aude Lemaitre / One Health Compliance