The Quality System: Connecting Art. 50 MedDO with Article 10 of the EU MDR

This article is issue 25 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

An ISO 13485 certificate is valuable evidence in Switzerland, but it only proves that the system conforms to the standard’s requirements; it does not prove that the system covers all the matters required by MedDO. MedDO Art. 50 points the manufacturer’s other obligations — the quality and risk management system — to Article 10 of the EU MDR. Article 10 of the EU MDR demands more than ISO 13485 reaches: risk management, the post-market surveillance system, the link between clinical evaluation and PMCF, the configuration of PRRC duties, and the maintenance mechanism for technical documentation. None of these is covered by a single system certificate. The evidence package for the quality system should therefore be a combination: the certificate, a list of procedures, and sampled records.

2. Legal basis

3. Expert insights

1. The probative force of a certificate stops at existence and does not reach operation. An ISO 13485 certification answers whether a documented system exists and has passed a third-party audit. What Swissmedic cares about during market surveillance under TPA Art. 58 is whether the system is running and leaving records. There is a visible gap between the two: a company whose certificate is still valid may nonetheless have no traceable records in post-market surveillance, trend analysis or corrective actions. Making the certificate the sole carrier of system evidence is therefore the most common proof gap. The remedy is to provide a list of procedure documents plus sampled records of key processes (internal audits, management reviews, closed CAPA loops), each sample traceable to the procedure clause it evidences.

2. The scope of a system certificate is often misaligned with the product scope. The audit scope is fixed by the certification body and may cover only one site, one product category or one process. If a device placed on the Swiss market falls outside the certificate’s scope, the certificate has zero evidential value in the Swiss context. This misalignment is especially common in group companies: production sites and the certified entity sit in different countries, the certificate is held in the factory’s name, while the responsible party under MedDO is the manufacturer. Checking the site and product lists in the certificate annex matters more than checking the certificate itself (practical estimate).

3. Swiss-specific obligations must be mapped into the system documents separately. Art. 50 points to Article 10 of the EU MDR, but Switzerland imposes a set of own obligations that are not in Article 10: a permanent PRRC at the CH-REP (Art. 52(1)), the 7-day response for technical documentation (Art. 51(3bis)), registration of economic operators and reporting of changes within 1 week (Art. 55(2)), and vigilance and trend reporting (Art. 66(1) and (2bis)). These are procedural duties specific to Switzerland. If the system documents contain no corresponding procedures and no named owners, even a complete certificate will not cover them. The trade-off: you need not build a separate system for Switzerland, but you must hold a mapping table from Swiss obligations to system procedures to responsible persons, hanging the Swiss clauses onto existing procedures.

4. Practical recommendations

1. Prepare a three-part system evidence package: the ISO 13485 certificate (with site and product scopes from its annex), the list of procedure documents, and sampled records of key processes.
2. Check whether the product scope in the certificate annex covers all devices placed on the Swiss market; for anything not covered, provide a separate explanation and supplementary coverage evidence.
3. Build a mapping table from Swiss obligations to system procedures to responsible persons, covering at least the permanent PRRC, the 7-day technical documentation response, registration and the 1-week change report, and vigilance reporting.
4. Write the links between post-market surveillance, trend analysis, PMCF and clinical evaluation into procedure documents, so the three processes do not run in isolation.
5. Include dedicated Swiss-clause checkpoints in the internal audit plan at least once per year, and retain the audit records.

5. Verification checklist

• □ The ISO 13485 certificate is valid, and the site and product scopes in its annex cover the devices placed on the Swiss market
• □ A list of procedure documents has been provided, covering design, production, post-market surveillance, CAPA and internal audits
• □ Sampled records of key processes have been provided (internal audit reports, management review records, closed CAPA records)
• □ A mapping table from Swiss-specific obligations to system procedures exists, with a named owner for each item
• □ PRRC duties are written into the system documents and are consistent with the configuration under Art. 49 / Art. 52
• □ The internal audit plan includes dedicated checkpoints for the Swiss clauses

Legal information verified as of 29 October 2026.

GRZAN delivers registration documentation and conformity file support for the Swiss market: quality system evidence packages, Swiss-obligation mapping tables, procedure document reviews and audit preparation aligned with Art. 50 MedDO and Article 10 of the EU MDR. Our consultants make your system evidence complete before Swissmedic asks. For assistance, contact GRZAN at info@grzanglobal.com. We also prepare system documentation for multi-site and group structures.