The PRRC Qualification Matrix: Art. 49 Manufacturer and Art. 52 CH-REP Configuration

This article is issue 26 of Volume 3, Registration Dossiers and Technical Requirements, of the 50-article series on medical device registration in Switzerland. Together with the other nine issues in this volume it forms a complete deliverable on this topic; the publication timestamp, issue number, title and unique URL are shown in the table below.

1. Key takeaways

Switzerland requires two PRRCs, not one. MedDO Art. 49 requires the manufacturer to appoint a person responsible for regulatory compliance, to divide duties in writing where several persons share responsibility, and to protect the PRRC from any detrimental treatment arising from their duties. Art. 52(1) requires the CH-REP to have at least one PRRC with the requisite expertise in the Ordinance available permanently and continuously, with the remainder governed mutatis mutandis by Art. 49(2)–(4). The wording permanently and continuously in Art. 52(1) is a Swiss-specific addition with no counterpart in the EU MDR. The realistic configuration for a manufacturer outside Switzerland is one PRRC on the manufacturer’s side plus one PRRC on the CH-REP’s side; their duties differ and neither can substitute for the other.

2. Legal basis

3. Expert insights

1. The knowledge profiles of the two PRRCs are not the same set. The manufacturer-side PRRC must cover the product itself: design, risk management, clinical evaluation and maintenance of the technical documentation — a profile built on product and technology. The CH-REP-side PRRC must cover Swiss law: the structure of MedDO/IvDO, language requirements, registration and notification duties, and vigilance deadlines — a profile built on Swiss regulation. The two profiles overlap only in the formal review of conformity assessment and documentation. Having one person cover both sides does not formally violate Art. 49 or Art. 52, but the phrase permanently and continuously refers to availability and continuity: a person living outside Switzerland who cannot respond within Swiss working hours will hardly be found to satisfy that requirement (practical estimate).

2. The division of duties must be written down, and must cover conflict scenarios. Art. 49 requires duties to be divided in writing where several persons share responsibility, and Art. 52(2) applies the same rule to the representative’s side. The real high-risk point in practice is not day-to-day division but conflict: when the manufacturer and the CH-REP disagree on whether an event must be reported, whose decision prevails? Art. 66(2bis) already provides one answer — where the CH-REP is involved, the CH-REP bears the reporting duty and must proactively submit trend reports covering both inside and outside Switzerland. In other words, on vigilance reporting the Swiss legislator has placed the responsibility on the entity inside Switzerland. If the mandate still says the manufacturer’s judgement prevails, it conflicts with the allocation in Art. 66(2bis).

3. Protection from detrimental treatment is an underestimated compliance item. Art. 49 states expressly that the PRRC must not be treated detrimentally for performing duties. For manufacturers outside Switzerland, Swiss labour law cannot simply be applied, but in a verification scenario the clause is read as meaning that the PRRC should have a reporting path independent of the business lines. If the PRRC also leads sales or operations, their judgement may be swayed by commercial targets — a point easily challenged in Swissmedic system inspections. The trade-off: small and medium-sized companies often cannot afford a dedicated PRRC, so the minimum viable configuration is to have the PRRC report directly to top management and to show this in the organisation chart (practical estimate). Documenting this independence in the quality manual makes it verifiable during inspections.

4. Practical recommendations

1. Build the PRRC matrix on a manufacturer-side plus CH-REP-side dual configuration, with qualification evidence and appointment documents retained on both sides.
2. Where several persons share responsibility, divide duties in writing under Art. 49 and state who decides in conflict scenarios.
3. Ensure the vigilance provisions of the mandate are consistent with Art. 66(2bis); any transfer of that duty from the manufacturer to the CH-REP must be agreed in writing.
4. Make the CH-REP-side PRRC permanently and continuously available: resident in Switzerland or responsive within Swiss working hours, with a deputy named.
5. Give the PRRC a reporting path in the organisation chart that is independent of sales and operations, and protect them from detrimental treatment.
6. On personnel changes, update the economic operator information in swissdamed in step; changes must be reported to Swissmedic within 1 week (Art. 55(2)).

5. Verification checklist

• □ PRRCs are appointed on both the manufacturer side and the CH-REP side, each with appointment documents and qualification evidence
• □ Where several persons share responsibility, duties have been divided in writing
• □ The permanent and continuous availability of the CH-REP-side PRRC is secured (residency or response within working hours), with a deputy
• □ The vigilance provisions of the mandate do not conflict with Art. 66(2bis)
• □ The PRRC reporting path is independent of sales and operations and is reflected in the organisation chart
• □ PRRC changes are integrated into the process of reporting to Swissmedic within 1 week

Legal information verified as of 29 October 2026.

GRZAN provides registration documentation and conformity file support for the Swiss market, including PRRC appointment frameworks, dual-configuration qualification matrices, mandate drafting consistent with Art. 66(2bis), and Swissdamed updates for personnel changes. Our team keeps both sides of your PRRC configuration inspection-ready. For assistance, contact GRZAN at info@grzanglobal.com.