GSPR in Practice: Proof Structure under Art. 6 MedDO and EU MDR Annex I

This article is issue 21 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

In Switzerland, the GSPR is not a statement of principle but a statutory precondition for placing a device on the market that can be cited directly against you. MedDO Art. 6(1)–(2) splits the condition into two sentences: the device must comply with the Ordinance itself, and it must meet the general safety and performance requirements set out in EU MDR Annex I. For a manufacturer holding EU CE technical documentation, that documentation can only ever cover the first half in Switzerland. Beyond Annex I, MedDO contains a set of Swiss-specific provisions — trilingual product information under Art. 16, the Swiss authorised representative under Art. 51, and registration under Art. 55 and Art. 108 — which fall entirely outside the reach of Annex I. The only structure that gives Swissmedic a complete, verifiable loop is a three-layer package: an article-by-article cross-reference table against Annex I, a gap table mapping the Swiss-specific provisions, and an evidence index pointing to the underlying documents. If any one of the three layers is missing, the submission will be sent back with a request for correction.

2. Legal basis

3. Expert insights

1. The cross-reference chain creates double actionability, and therefore double proof obligations. Switzerland does not copy the MDR text verbatim; instead, MedDO turns Annex I into Swiss law by reference. The benefit is that the body of the technical documentation can be reused without rewriting. The cost is that once Swissmedic opens market surveillance under TPA Art. 58, it can assess conformity with Annex I directly under Swiss law, without waiting for any position from an EU notified body. For manufacturers that already hold CE certification, this means that EU clearance is no longer a shield against Swiss supervision. Viewed from the other side, this is not entirely bad news: because the obligation originates in MedDO rather than in the MDR itself, the Swiss assessment standard is textually homologous with the EU one, so the technical documentation does not need to be rewritten — only the gap layer needs to be added.

2. Argument for a derogation loses more points than a claim of conformity. Most entries of Annex I can be dispatched with a single sentence stating conformity with harmonised standards. But every claim of derogation — that something is technically infeasible or inconsistent with the state of the art — shifts the burden of proof entirely onto the manufacturer. The common industry practice of copying a disclaimer sentence from an EU template will, in the Swiss verification context, trigger a demand for validation data on the alternative measures. The trade-off is real: claiming a derogation can save one round of testing, but if the claim is rejected, the time cost of retrofitting the validation far exceeds what it would have cost to design a comparable validation scheme for the alternative measures from the outset.

3. Treat the GSPR cross-reference table as a living document, not a deliverable. Many companies treat the GSPR table as a one-off annex to the technical documentation, signed and archived. In the Swiss setting this approach has a structural flaw: the latest version of MedDO takes effect from 1 July 2026, subsequent amendments will keep changing the content of the gap provisions, and Annex I itself is continuously being interpreted through MDCG guidance. The pragmatic approach is to hook the table into the change management process, so that any design change or standard transition triggers a review of the table. The downside is higher maintenance effort, but measured against repeated rework during swissdamed registration and annual reviews, the maintenance route is the cheaper one (practical estimate).

4. Practical recommendations

1. Build the three-layer table: layer one, EU MDR Annex I article by article; layer two, the Swiss-specific MedDO provisions (Art. 13, 15, 16, 51, 55, 108); layer three, an evidence index pointing each entry to a specific document number and version in the technical documentation.
2. For every GSPR entry claimed as conforming to harmonised standards, record the standard version and year of publication; whenever a standard is revised, re-verify whether the conclusion for that entry still holds.
3. For every entry where a derogation or relaxation is claimed, issue a separate validation scheme and data set for the alternative measures; do not fold these into a generic declaration of conformity.
4. Connect the cross-reference table to the change management process and link it to the change classification described in issue 30; design changes, material changes and software version changes must all trigger a review.
5. In the written mandate for the CH-REP, state explicitly who is responsible for handing over and updating the technical documentation, so the representative never holds an outdated version.

5. Verification checklist

• □ An article-by-article cross-reference table against EU MDR Annex I exists, and every entry has an evidence index (document number + version + page)
• □ A separate gap layer for the Swiss-specific MedDO provisions has been prepared, covering language, representative and registration
• □ The version and year of publication of every cited standard are recorded, and no superseded edition is cited
• □ Every derogation or relaxation entry is supported by validation data on the alternative measures
• □ The cross-reference table is hooked into the change management process with a named review owner
• □ The technical documentation version held by the CH-REP matches the manufacturer’s latest version, with hand-over records

Legal information verified as of 29 October 2026.

GRZAN supports medical device manufacturers entering the Swiss market with registration documentation and conformity file services: GSPR cross-reference tables and gap analyses against MedDO and EU MDR Annex I, technical documentation structuring and review, CH-REP coordination, and Swissmedic submission preparation. Our regulatory team builds evidence indexes and living conformity documents that withstand Swissmedic verification. For support with your Swiss registration dossier, contact GRZAN at info@grzanglobal.com.