Distributor due diligence under Art. 54 and the boundaries of sampling verification

This article is the 39th instalment of Volume 4, License-holder Import and Fees, of the Swiss Medical Device Registration 50-Article Series. Together with the remaining nine articles of this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below, so that readers can cite this article unambiguously and locate its companion pieces.

1. Key takeaways

Before placing devices on the market, the distributor must complete the five checks of Art. 54(1): conformity mark, declaration of conformity, product information, importer information provided under Art. 53(2), and UDI. Art. 54(2) allows the remaining items to be verified on a sampling basis, but the importer-information item is expressly excluded from sampling and must be checked item by item. Where a check fails, the device must not be placed (Art. 54(3)); the remaining duties follow EU MDR Art. 14 and Art. 16(3)(4) (Art. 54(4)). The architecture gives distributors real efficiency gains, but only for those who can demonstrate a defensible sampling method — and it draws one bright line around the importer information that no sampling plan can ever cross.

In practice the distributor sits at the point where the manufacturer’s homogeneity ends and the variability of the supply chain begins, which is exactly why the legislature gave the distributor a lighter instrument than the importer but removed the one item where upstream variability is greatest. The result is a duty that scales with distribution volume while staying anchored to the single most variable element in the chain.

2. Legal basis

3. Expert insights

1. The exclusion falls on importer information, and it was not chosen at random. The exemption of Art. 54(2) reads as excepting point (1)(d), which is precisely the item on whether the importer has provided information under Art. 53(2). The legislative judgment is that the other four items — conformity mark, declaration of conformity, product information, UDI — are highly homogeneous within one manufacturer’s product line, so sampling is sufficient to expose systematic gaps, whereas importer information varies with each batch and with each upstream supplier, so sampling can miss it. Read the other way round, this exclusion also makes the distributor a de facto supervisor of the importer’s labelling duty: once missing importer information is found, the distributor cannot seek exoneration through its sampling records.

1. Sampling is a method that must be demonstrated, not a convenience that can simply be declared. The provision allows sampling but specifies no ratio. This means the distributor must be able to justify the sampling plan — stratified by supplier, by product line, by batch — and retain the records; otherwise, at inspection, the assertion that sampling was done is no defence. The opposing view holds that sampling adds administrative cost and that full checking is simpler — for distributors with small SKU counts, full checking is indeed easier and legally safer, so the sampling option is a lever for scale, not a shortcut for everyone.

1. The duty lists of distributor and importer are nearly identical, but the legal consequences land in different places. The importer has no sampling exemption; the distributor does. The distributor has no mandatory CHRN registration duty (the entities listed in Art. 55(1) do not include the distributor); the importer does. This combination produces a practical judgment: placing the importer role outside the group’s Swiss entity and keeping only a Swiss distributor makes the full verification duty of Art. 53 fall on the foreign entity, while the domestic distributor, thanks to the sampling exemption, bears lighter duties — yet when the regulator traces back, the first entity it finds is the distributor, which can then invoke sampling. Responsibility and traceability therefore risk becoming mismatched, and groups should treat this constellation with care rather than as a planning trick.

4. Practical recommendations

1. Make the importer-information check of Art. 54(1)(d) a 100% item-by-item check, managed separately from the four samplable items.
2. Build a written sampling plan for the four samplable items, stating the stratification basis (supplier / product line / batch) and the sampling ratio, and retain the sampling records and the resulting judgments.
3. Where a check fails, stop the placement under Art. 54(3) and retain the quarantine and disposal records, avoiding any pattern of sell first and remedy later.
4. Agree information-supply duties with upstream partners: require the importer to provide written evidence of the three elements of Art. 53(2) at delivery, reducing the distributor’s verification cost.
5. Clarify the boundary of your own role: where you actually perform the import of foreign products, perform the Art. 53 duties as the importer and obtain a CHRN — never let the distributor identity cover an import activity.

5. Verification checklist

• □ The five checks of Art. 54(1) have been identified, with the importer information of (1)(d) designated as a non-samplable item
• □ A written sampling plan for the four samplable items exists, with stratification basis and sampling ratio
• □ Sampling records and judgment outcomes are retained and traceable
• □ The stop-placement and disposal process for failed checks is in operation (Art. 54(3))
• □ The entity’s own role has been confirmed: importers obtain a CHRN, distributors have no mandatory registration duty
• □ The information-supply arrangement with upstream partners is written into purchase or distribution agreements

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For distribution GRZAN provides Swiss authorized representative (CH-REP) services, helps importers meet the Art. 53(2) information-supply duty that distributors must verify item by item, reviews distributor sampling plans for defensibility at inspection, and builds fee budget models covering CHRN fixed fees, registration fees and hourly-based charges. For CH-REP appointment, distributor compliance review or fee budgeting support for the Swiss market, contact info@grzanglobal.com.