One of the most underestimated sections in technical documentation under the MDR is the General Safety and Performance Requirements (GSPR) checklist. Many manufacturers still treat it as a checklist or a late-stage formality. However, the recently published Version 3 of the Team-NB Position Paper “Best Practice Guidance for the Content of the Technical Documentation under EU MDR (2017/745)” makes it clear: this approach is no longer acceptable.
The GSPR section must present a structured, traceable, and justified demonstration of conformity with Annex I of the MDR. It is no longer sufficient to merely state compliance or generally refer to supporting documents. The Position Paper explicitly calls for precise references – down to the section, page, or chapter – within controlled documents, allowing reviewers to efficiently verify each claim. Justifications for exclusions or partial application of GSPR’s must be well-reasoned and properly documented. Vague or unsupported statements are now among the most common pitfalls leading to delays or non-acceptance of the technical documentation during the conformity assessment process. Additionally, the use of draft documents, lack of version control, and imprecise references remain recurring deficiencies.
The GSPR checklist should not stand in isolation but serve as a central traceability tool that links together risk management, clinical evaluation, usability, biological safety, and performance data. Without clear integration, inconsistencies arise and the credibility of the entire technical documentation is weakened.
Manufacturers are also expected to demonstrate how each applicable GSPR is met, referring to specific harmonised standards, Common Specifications, or alternative solutions – with detailed explanations if a standard is only partially applied or replaced. Gap analyses and risk-based justifications are required when relying on outdated or non-harmonised standards.
Another critical issue highlighted in the Position Paper is the frequent lack of rationale for applied standards. Referencing a standard without explaining its relevance to the device or specifying which parts have been used is no longer acceptable.
In short, Notified Bodies now expect a GSPR section that is demonstrably complete, coherent, and fully traceable. Manufacturers who still treat it as a formality risk major delays or rejection. Those who plan early, involve cross-functional teams, and integrate GSPR requirements throughout the technical file will be far better positioned for a smooth conformity assessment.
At Starodub, our team of experts helps manufacturers navigate these evolving expectations by providing strategic guidance, hands-on support with technical documentation, and in-depth reviews of GSPR checklists and supporting evidence. If your team needs support with MDR compliance including GSPR, feel free to reach out to us at [email protected].
