Biocompatibility, Sterilisation and Shelf-Life Evidence

1. Key takeaways

Three areas of technical argumentation attract supplementary evidence requests more often than any others, and each maps to a defined group of points in Ek I. Knowing where reviewers concentrate their attention allows the file to be built right the first time, which in turn shortens the conformity assessment itself. The overlap is not accidental: properties, infection control and shelf life are the three fronts on which a device’s claim to be safe over its lifetime is argued, and reviewers sample them accordingly. The takeaways below identify where each argument must be built.

• The three areas of technical argumentation most frequently drawing supplementary requests correspond respectively to three groups of points in Ek I: chemical, physical and biological properties (point 10), infection and microbial contamination (point 11), and the evidence relating to shelf life and the demonstration of performance over time.
• Point 10 subdivides further: section 10.4 deals with CMR and endocrine-disrupting substances, and section 10.6 deals with nanomaterials. These two sections have become dense areas of review in recent years.
• Class IIa and above devices typically enter the technical documentation assessment route (paragraph 4 point (a) of Madde 52 makes this explicit for Class IIb), so the completeness of the three groups of evidence above directly determines the length of the assessment.
• The underlying logic is that the technical documentation must allow conformity to be assessed on its basis (paragraph 4 of Madde 10). Argumentation that states only conclusions, without methods and acceptance criteria, does not meet this standard.

2. Legal basis

The evidence requirements discussed here draw on two regulations and a short list of annex points: the general requirements on properties and on infection in Ek I, the assessment route for higher-risk classes in Madde 52, and the corresponding duties of IVD manufacturers. Because these points are read together during assessment, gaps in one area often draw questions into the others. The table consolidates the citations.

3. Expert insights

Insight one: point 10 is a set of requirements, not a single test item. It covers chemical, physical and biological properties, subdivided into sections such as 10.4 (CMR and endocrine disruption) and 10.6 (nanomaterials). Treating it as one biocompatibility report is not enough — what is needed is a set of documents covering the full materials argumentation. Each subsection raises its own questions about substances, exposure and justification, and a file that answers only the biocompatibility question leaves the other subsections open to challenge. A useful discipline is to read point 10 subsection by subsection against the product’s material list, marking each subsection as addressed, addressed with justification or not applicable, so the coverage decision is itself documented. Subsection coverage of this kind also gives the notified body a single place to see scope decisions, which shortens clarification rounds.

Insight two: sterilisation attaches to point 11, and shelf life attaches to the stability argumentation. Point 11 addresses infection and microbial contamination, and it is where the argumentation on sterilisation validation and sterile barrier systems converges. The shelf-life argumentation, for its part, must be built on stability data and packaging verification. The two topics travel together through review: a shelf life claimed without validated barriers, or a barrier validated without a claimed shelf life, reads as half of an argument that the reviewer expects to see completed. Planning the two argumentations together also avoids the scheduling conflict of running stability studies after the barrier design has been frozen. Reviewers tend to test the join between the two, so cross-references in the file should be explicit.

Insight three: the Class IIb technical documentation assessment is a sampling exercise, not a full inspection. The wording of paragraph 4 point (a) of Madde 52 is an assessment of at least one device in each device family group. This arrangement means that the unit selected must be complete enough, because its conclusions will be extrapolated to the whole group. Choosing the representative unit is therefore itself a strategic decision: it should be the configuration that exercises the fullest set of properties and justifications the family has to offer. Sampling therefore rewards preparation: the earlier the representative unit is agreed, the less risk that a late choice forces additional testing on an incomplete configuration.

4. Practical recommendations

• For each group of evidence, build a four-part structure of conclusion plus method plus acceptance criteria plus index to raw data, benchmarked directly against the assessability standard of paragraph 4 of Madde 10.
• For Class IIb and III, confirm in advance which unit or group the notified body will sample, and thicken the evidence for that group first.
• Validation protocols relating to sterilisation and shelf life should be discussed with the notified body or a professional body before execution, to avoid rework afterwards.

5. Verification checklist

• □ The evidence for point 10 of Ek I covers chemical, physical and biological properties.
• □ Where CMR / endocrine-disrupting substances are involved, section 10.4 has been addressed.
• □ Where nanomaterials are involved, section 10.6 has been addressed.
• □ Sterilisation validation, sterile barriers and shelf-life stability data are complete (point 11 and the corresponding argumentation).
• □ For Class IIb / III, the representative device to be sampled and its family grouping have been confirmed.

Regulatory information verified to 29 October 2026. The provisions and Ek I points listed in this article were checked against the current text and the annex on the Turkish legislative information system (MevzuatNo 38657).

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Turkish market. Our team prepares CE/UTS-compliant documentation, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com