CH-REP must maintain a PRRC: the Swiss-specific addition in MedDO Art. 52

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

The CH-REP is not a figurehead entity: Art. 52(1) obliges it to have permanently and continuously at its disposal at least one regulatory compliance officer (PRRC) who possesses the requisite expertise under the ordinance. This is a Swiss addition to the EU framework; under the EU MDR the PRRC requirement is addressed to manufacturers, and authorised representatives do not carry an equivalent standing PRRC duty. When a manufacturer outside Switzerland selects a CH-REP, whether a PRRC is in place should be treated as a veto criterion — a candidate representative that cannot demonstrate a standing PRRC fails the selection regardless of price, references or service breadth, because the obligation is not delegable away by contract. In practice the check is simple: ask for the PRRC’s name, role and availability in writing, and treat any evasive answer as a signal to reconsider the appointment before the mandate is signed.

2. Legal basis

3. Expert insights

1. Permanently and continuously rules out the part-time attachment model. The wording of Art. 52(1) is permanently and continuously at its disposal, applied to a PRRC with the expertise required by the ordinance. Engaging an external consultant on an on-call basis, or simply copying the name of the group’s EU PRRC onto the Swiss entity, does not satisfy the standing requirement: the person must be genuinely available to the Swiss representative, not borrowed episodically when a query arises. The requirement attaches to the representative as a condition of acting in that role at all, which is why a named, reachable, qualified person matters more than any service-level promise in the commercial agreement.
2. The cross-reference to Art. 49(2)–(4) brings two ancillary duties. Art. 52(2) extends the manufacturer PRRC rules to representatives: where several persons are jointly responsible, the allocation of responsibilities must be set out in writing, and the PRRC may not be disadvantaged for performing the role. The first requirement obliges the CH-REP to produce a written allocation of responsibilities document; the second in substance demands organisational independence for the PRRC. Manufacturers can and should use the mandate letter to secure a right to inspect that document.
3. EU experience cannot simply be transposed. Companies often respond to the Swiss requirement by noting that they already have an EU PRRC, but under the EU framework the PRRC duty sits with the manufacturer and there is no statutory standing requirement on the representative side. Switzerland attaches the same set of duties to the representative, effectively creating a new professional position that must be continuously staffed somewhere in the supply chain — a cost structure that differs fundamentally from the EU model.
4. The cost of a missing PRRC is magnified by the hourly fee rate. Under Art. 4(2), Swissmedic’s hourly rate is CHF 270 per working hour from 1 July 2026 (previously CHF 200 until 30 June 2026, unchanged since 2002). Repeated requests to supplement documents and additional communication rounds caused by an absent PRRC are charged on actual hours, and ongoing procedures are billed on the date the service is provided. The true price of the gap therefore shows up months later on a Swissmedic invoice.

4. Practical recommendations

1. Require in the mandate letter a written declaration from the CH-REP identifying the PRRC by name, with qualification evidence and confirmation of availability, and agree a notice period for changes.
2. Where the CH-REP allocates PRRC duties across several persons, obtain the written allocation of responsibilities under Art. 49 and keep it on file.
3. Integrate the PRRC into the technical documentation retrieval chain: the 7-day direct submission arrangement of Art. 51(3bis) requires the PRRC to judge the scope of the request and the submission perimeter, which commercial staff alone cannot deliver.
4. Require the CH-REP’s quality system to use ISO 13485 as one of its baselines and to hold valid certification, as the organisational safeguard behind PRRC performance.
5. Re-estimate Swissmedic communication costs for the second half of 2026 onwards on the basis of CHF 270 per working hour, and cut avoidable back-and-forth rounds.

5. Verification checklist

• □ The CH-REP has confirmed in writing the availability of at least one standing PRRC and provided qualification evidence.
• □ Where several persons are jointly responsible, the written allocation of responsibilities under Art. 49 has been issued.
• □ The mandate letter contains the PRRC change notification duty and an agreed notice period.
• □ The PRRC has been integrated into the 7-day technical documentation retrieval and submission workflow.
• □ The CH-REP’s quality system evidence (ISO 13485 and similar) is within its validity period.
• □ The internal 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 CH-REP selection with PRRC due diligence, mandate drafting and Swissmedic communication cost planning. For support with your Swiss representative arrangements, contact GRZAN at info@grzanglobal.com.