Clinical investigations and performance studies: the HRA and ClinO-MD (SR 810.306)

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

Clinical investigations in Switzerland are not regulated in the MedDO; they are governed by the Human Research Act (HRA, SR 810.30) and its subordinate ordinance, the Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306). The reference SR 810.306 itself signals that it belongs to the human research family of law, not the therapeutic products family. When a company runs a clinical investigation in Switzerland, the compliance backbone is research law, not the device market access ordinance. Treating the study as a pre-step of device registration misaligns the entire documentation system, the responsible entities and the applicable deadlines, because the two legal families ask different questions: one asks whether subjects are protected and the study is ethical, the other asks whether the product is safe and performs as intended on the market.

2. Legal basis

3. Expert insights

1. The divide in SR numbers determines two different regulatory languages. ClinO-MD at SR 810.306 and the MedDO at SR 812.213 sit in different legal families: the former belongs to the HRA (SR 810.30) and is concerned with subject protection and research ethics; the latter belongs to the TPA (SR 812.21) and is concerned with the safety and performance of products placed on the market. Managing a clinical investigation as a pre-step of device registration produces a wholesale mismatch in documentation, responsibility allocation and deadlines.
2. Devices for clinical investigation are expressly excluded from the conformity mark. MedDO Art. 13(2) lists the situations in which the conformity mark must not be affixed, including devices for clinical investigation (the same provision covers custom-made devices, devices for demonstration, systems and procedure packs, and devices under Art. 9). This matches the nature of the investigational stage: the device has not completed conformity assessment, and affixing the mark would send a false signal to subjects and users.
3. Safety events during research still have a reporting outlet. TPA Art. 59 sets out the notification duties, with paragraph 3 covering user reports; MedDO Art. 66(4) further requires professionals who identify a serious incident during use to report it to the supplier and Swissmedic, with the timelines of Article 87 of the EU MDR. Swissmedic publishes the Incident report user form (MU680_20_008e_WL, version of 1 April 2026) as the entry point for user reports, showing that research contexts and use contexts are not separated at the reporting channel level.
4. Swissmedic’s position is consistent on both lines: no consultations. Whether the question concerns device characterisation, classification, registration or placing on the market, Swissmedic does not provide advice; private consultants must be engaged. Related procedures are billed on actual hours at CHF 270 per working hour from 1 July 2026. The compliance judgment on the investigation plan must therefore be made in advance inside the company or by external advisers, not left to prior confirmation from the regulator.

4. Practical recommendations

1. Determine the legal family at project initiation: projects involving human research follow the HRA and the ClinO-MD (SR 810.306), purely pre-market testing follows the MedDO system, and the documentation of the two lines must not be mixed.
2. Handle labelling of investigational devices under Art. 13(2) without affixing the conformity mark, and state the investigational purpose on the label and accompanying documents.
3. Establish the serious incident reporting chain for the research phase: investigator, then supplier, then Swissmedic, with timelines per Article 87 of the EU MDR and submission via the electronic channels and forms published by Swissmedic (Incident report user, version of 1 April 2026).
4. Bring the production and controlled management of investigational devices within a system using ISO 13485 as one of its baselines, retaining batch records and release records.
5. Budget external adviser fees and Swissmedic communication costs at CHF 270 per working hour together into the study budget.

5. Verification checklist

• □ It has been determined whether the project falls under the HRA and ClinO-MD (SR 810.306) or the MedDO system.
• □ Devices for clinical investigation are handled under Art. 13(2) with no conformity mark affixed.
• □ The serious incident reporting chain and timelines (per Article 87 of the EU MDR) are set out in the study plan.
• □ The Swissmedic electronic submission channels and form version (Incident report user, 1 April 2026) have been confirmed.
• □ Production and release records for investigational devices are held within the quality system (ISO 13485 and similar).
• □ The budget has been estimated 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 Swiss clinical investigation set-up under the HRA and ClinO-MD and post-market reporting chain design. For support with your Swiss study programme, contact GRZAN at info@grzanglobal.com.