MedDO and EU MDR: Equivalent by Reference, Yet Not Identical

This article is number 02 in Volume 1, Regulatory Framework and Fundamentals, of the fifty-part series on medical device registration in Switzerland. Together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, article title and unique URL are listed in the table below.

1. Key takeaways

The relationship between MedDO and the EU MDR is best described as equivalence by citation with local additions: wherever MedDO expressly cites an MDR annex or provision, that text forms part of Swiss obligations, and where it does not, Switzerland applies its own rules. At least 4 provisions go beyond the EU level — Art. 51(3bis), Art. 52(1), Art. 66(2bis) and Art. 16(2). When working on Swiss compliance, return to MedDO article by article to confirm the actual scope of each citation; an EU compliance package cannot be presumed sufficient on its own, because the Swiss legislator deliberately reserved several points where higher requirements apply.

2. Legal basis

Verification entry points: the citation provisions of MedDO (SR 812.213) set against the annexes of EU MDR 2017/745, provision by provision; use the current versions on Fedlex and EUR-Lex as the authoritative references. Reconciling the two texts side by side is the only reliable way to establish where Swiss law simply incorporates EU law and where it deliberately departs from it.

3. Expert insights

1. The drafting technique of citation determines how compliance research must be done. MedDO does not reproduce EU provisions; it states that a given MDR article or annex applies, keeping the Swiss text light and able to track EU updates. The price is that citations are static: an EU amendment does not automatically become Swiss law. Conclusion: every new EU obligation must first be traced to a citation provision in MedDO before it can be claimed to apply in Switzerland; otherwise it is industry practice, not a legal requirement.
2. Four Swiss additions raise the fixed cost of the representative side. Art. 51(3bis) allows an agreement under which the manufacturer submits the technical documentation directly to Swissmedic, but the CH-REP must ensure submission within 7 days. Art. 52(1) requires the CH-REP to permanently and continuously maintain at least one PRRC with expert knowledge of the ordinance. Art. 66(2bis) places reporting responsibility in Switzerland on the CH-REP where one is required, including proactive submission of trend reports for events inside and outside Switzerland. Art. 16(2) mandates the three languages German, French and Italian. The trade-off: Switzerland buys an accountable domestic contact point at higher cost, which simplifies cross-border evidence gathering. The counterpoint is that a CH-REP operating as a nominal letterbox conflicts directly with the standing requirement of Art. 52(1) and will be exposed at the first inspection.
3. The dual-track conformity mark leaves room for deliberate decisions. Art. 13(1) requires the Swiss conformity mark under MedDO Annex 5 while also accepting the CE mark under EU MDR Annex V. Conclusion: Switzerland does not force a re-marking, but Art. 13(3) requires the number of the notified body or designated body to accompany the mark. Whether to switch marks should be decided together with the division of labour with the CH-REP and the layout of trilingual labelling, not in isolation based on printing cost alone, because the decisions interact operationally.

4. Practical recommendations

1. Turn every MedDO provision that cites the MDR into a checklist entry, marking for each whether Switzerland imposes an additional requirement on top of the EU rule.
2. Before appointing a CH-REP, obtain written confirmation of its standing PRRC configuration and the qualifications of the personnel (Art. 52(1)).
3. Fix the 7-day technical documentation submission duty and the transfer of vigilance reporting responsibilities in the mandate agreement itself, to prevent later disputes.
4. Finalise the language scheme before conformity assessment starts, so that instructions for use and labels do not have to be redone at a late stage.
5. The hourly fee rate is CHF 270 per working hour from 1 July 2026 (previously CHF 200); include the working hours spent on deficiency corrections and authority queries in the budget.

5. Verification checklist

• □ The scope of MedDO citations of the MDR has been checked provision by provision, without equivalence presumptions
• □ The CH-REP has confirmed in writing a standing PRRC (Art. 52(1))
• □ The mandate agreement covers 7-day technical documentation submission and transfer of vigilance duties
• □ The trilingual product information scheme is finalised and reflected in the project plan
• □ The conformity mark scheme (MedDO Annex 5 or CE) is decided and includes the designated body number
• □ The budget has been recalculated at the hourly rate of CHF 270

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers and economic operators entering the Swiss market with end-to-end Swissmedic registration and compliance services, including MedDO citation mapping against the EU MDR, CH-REP selection and mandate drafting, PRRC compliance reviews, labelling and language schemes, and fee budgeting under FeeO-Swissmedic. Our team converts the equivalence-plus-additions structure described above into a provision-level action list. For tailored guidance on your product portfolio, contact info@grzanglobal.com.