Conformity assessment and the designated body: when third-party involvement is required

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the eighteenth 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

Whether third-party involvement is required is determined jointly by the risk class and the product characteristics: MedDO Art. 23 points the conformity assessment routes to Article 52 of the EU MDR, and most Class I devices that are non-sterile, non-measuring and non-reusable surgical instruments may self-declare conformity, while all other classes and reusable surgical instruments require a certificate issued by a designated body (the Swiss-law term corresponding to the EU notion of a notified body). The decision sequence is to classify first (Art. 15), then select the route (Art. 23), and finally attach the body’s number next to the conformity mark under Art. 13(3). Getting the sequence wrong in either direction is costly: over-engaging a body wastes fees and time on products that could self-declare, while under-engaging one invalidates the mark and blocks market access outright.

2. Legal basis

3. Expert insights

1. Switzerland has not created a separate conformity assessment regime; the difference lies in how the body’s number is displayed. Art. 23 applies Article 52 of the EU MDR directly, so route selection is identical to the EU. The genuinely Swiss step is in Art. 13(3): the designated body’s number must be shown next to the conformity mark, complementing Art. 13(1), which allows either the Swiss Annex 5 mark or the CE mark under Annex V of the EU MDR. Companies that manage only the EU side of certificate administration often miss how the number must appear on Swiss labelling.
2. Reusable surgical instruments are the exception within Class I. Under Article 52 of the EU MDR, reusable surgical instruments require a designated body to be involved and to issue a certificate for the reprocessing-related aspects. The intuition that this category self-declares, common in the EU, leads to the same third-party requirement in Switzerland once Art. 23 applies the EU MDR route; the Class I label in the classification table is misleading for this product group.
3. Even supply chain roles can trigger a third-party audit. Art. 53(4) and Art. 54(4), combined with Article 16(3)(4) of the EU MDR, allow importers and distributors to translate product information, or to repackage or relabel devices. Repackaged or relabelled devices must be notified to Swissmedic before being placed on the market, and the quality system of the operator performing those activities must be audited and certified by a designated body. An importer that only does logistics but does not touch the product can therefore still be drawn into a designated body audit.
4. Swissmedic gives no advance rulings, so the classification judgment rests with the company itself. Swissmedic expressly does not provide advice on the development, characterisation, classification, registration or placing on the market of devices; private consultants must be engaged at the manufacturer’s own initiative. Combined with the hourly rate of CHF 270 per working hour from 1 July 2026, the cost of a classification error shows up twice: in the rework of the certificate route and in the hourly billing of the resulting correspondence.

4. Practical recommendations

1. Build a three-step classification–route–body decision table: grade the device under Art. 15 and Annex VIII of the EU MDR, select the route under Art. 23 and Article 52 of the EU MDR, and confirm the certificate and body number.
2. Maintain a separate ledger for reusable surgical instruments and treat them as requiring designated body involvement, not the Class I self-declaration process.
3. Lay out labels and conformity marks under Art. 13(3) and Art. 14 with the body’s number adjacent to the mark, in the order device itself/sterile packaging, then packaging, then instructions for use and sales packaging.
4. For importers and distributors involved in repackaging or relabelling, arrange the designated body audit and certification of their quality system early, and fulfil the pre-placement notification duty.
5. Establish the quality system with ISO 13485 as one of its baselines so existing system documents and audit records can be reused directly in the designated body audit.

5. Verification checklist

• □ Every device has been classified under Art. 15 and Annex VIII of the EU MDR, with a documented written basis.
• □ The conformity assessment route has been confirmed under Art. 23 and Article 52 of the EU MDR, including whether a designated body is required.
• □ Reusable surgical instruments are being handled as requiring third-party involvement.
• □ The conformity mark and the designated body’s number are affixed in accordance with Art. 13(3) and Art. 14.
• □ Notification and quality system certification for repackaging or relabelling scenarios have been completed.
• □ The budget has been recalculated at CHF 270 per working hour (from 1 July 2026).

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with registration pathway and classification strategy services, including route selection under MedDO Art. 23 and designated body engagement planning. For support with your Swiss conformity assessment strategy, contact GRZAN at info@grzanglobal.com.