Pathway selection for borderline products: combination products, software and non-medical-purpose devices

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the twentieth instalment; together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are shown in the table below.

1. Key takeaways

Pathway assignment for borderline products is a one-step determination: first read MedDO Art. 1(3) and Art. 2 to establish whether the product falls within the scope of the device ordinance. If it does, grade it under Art. 15 and Annex VIII of the EU MDR and follow the standard chain of conformity assessment, CH-REP, CHRN and swissdamed; if it does not — for example an integral medicine-device combination — the primary pathway shifts to medicines law, with the device ordinance applying only to its device-related parts. Every downstream obligation, from labelling languages to registration fees, depends on this first determination, so it should be documented per product with reasons, not inferred from habit or from how the product is treated in other markets.

2. Legal basis

3. Expert insights

1. Art. 1(3) is the inclusion clause and Art. 2 is the exclusion clause, and they must be read against each other. Art. 1(3) brings into the device ordinance medicinal product combinations, devices incorporating inactivated animal or human tissue, and products incorporating an IVD component; Art. 2 then excludes blood products, living biological materials, IVDs and integral medicine-device combinations. The difference between a medicinal product combination and an integral medicine-device combination is a single phrase, yet it points to two entirely different primary pathways: the former stays within the device ordinance with additional medicinal requirements layered on, while the latter moves to medicines law as its primary regime.
2. The compliance cost of software is decided by the classification rules, not by the fact that it is software. Software products have no separate category in Switzerland; they are still graded under Art. 15 and Annex VIII of the EU MDR into one of Classes I, IIa, IIb or III. The counter-intuitive result is that a clinical decision-support product may carry a higher class than a physical consumable, with correspondingly heavier conformity assessment, clinical evaluation and designated body involvement. Budgeting software as a low-risk category is the most common cost misjudgement.
3. Non-medical-purpose products entering the device ordinance take on a one-off new compliance burden. The non-medical-purpose products listed in Annex 1 (including certain aesthetic devices) are subject to the MedDO in Switzerland, so the technical documentation, quality system and vigilance processes that were previously unnecessary must all be built up. The counterweight is that inclusion brings a clear compliance route and predictable market access conditions, a lower long-term risk than selling in the grey zone.
4. In-house manufactured devices of healthcare establishments and custom-made devices are two narrow paths, and neither carries a conformity mark. Art. 9 governs in-house manufactured devices, Art. 13(2)(e) refers to that provision and confirms no conformity mark, and Art. 18 requires notification before being put into service; Art. 19 sets out the notification duty for custom-made devices (current Swissmedic notification pages, forms BW630_30_026e_FO and BW630_30_027e_FO, both dated 26 May 2021). These routes involve no conformity assessment and no ordinary swissdamed registration; traceability rests on the notification duties alone.

4. Practical recommendations

1. Build a borderline product decision table: first judge inclusion under Art. 1(3), then exclusion under Art. 2, archiving the conclusions and reasons item by item in both columns.
2. Grade software products separately under Art. 15 and Annex VIII of the EU MDR; do not carry over the class conclusion of a physical device in the same product line.
3. For non-medical-purpose products, complete the technical documentation, the trilingual product information (Art. 16(2)) and the vigilance processes, and register under Art. 55 within 3 months of first placing on the market, at the fixed registration fee of CHF 200.
4. Fulfil the notification duties for in-house manufactured and custom-made devices under Art. 18 and Art. 19 using the current Swissmedic forms, and do not process them through the ordinary placing-on-the-market flow.
5. Bring the design and production of borderline products within a system using ISO 13485 as one of its baselines, retaining the determination records and technical documentation for inspection.

5. Verification checklist

• □ For every borderline product, the conclusions and reasons of the Art. 1(3) inclusion judgment and the Art. 2 exclusion judgment are recorded.
• □ Medicinal product combinations and integral medicine-device combinations are handled separately, with no confusion in the primary pathway determination.
• □ Software products have been graded separately under Art. 15 and Annex VIII of the EU MDR.
• □ Non-medical-purpose products have complete technical documentation, trilingual product information and vigilance processes.
• □ In-house manufactured devices (Art. 9, Art. 18) and custom-made devices (Art. 19) follow the notification pathway with no conformity mark affixed.
• □ The quality system (ISO 13485 and similar) covers the design and production of borderline products, with valid certification.

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with registration pathway and classification strategy services, including borderline product determinations under MedDO Art. 1(3) and Art. 2, software grading and notification duties. For support with your Swiss borderline portfolio, contact GRZAN at info@grzanglobal.com.