Importer labelling duties: Art. 53(2) and the Swiss reading of accompanying documents

This article is the 38th 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

The importer must state three elements on the device itself, the packaging or the accompanying documents: its name, its place of business and its contact address (Art. 53(2)). The Swiss interpretation of accompanying documents is broader than MDCG 2021-27 question 8 and allows the importer information to be placed on the accompanying documents rather than on the label. This does not lighten the duty: the importer must still complete the five checks of Art. 53(1) before placing on the market — conformity mark, declaration of conformity issued, CH-REP designated under Art. 51, labelling and instructions for use present, and the manufacturer having assigned a UDI — and where a check fails, the device must not be placed (Art. 53(3)). The two duties stand side by side, and satisfying one never excuses the other.

2. Legal basis

3. Expert insights

1. The Swiss interpretation of accompanying documents is a pragmatic relief and a narrow path at the same time. The wording of Art. 53(2) lists the device, the packaging and the accompanying documents as three parallel carriers, and Switzerland accordingly allows the importer information to be carried on the accompanying documents, which is broader than the treatment in MDCG 2021-27 question 8. The trade-off is clear: it avoids reprinting labels for every small-format device, at the cost that the accompanying documents must remain bound to the device within the same distribution unit. Once the documents separate from the device — split shipments, secondary repacking — the labelling fails. The criterion is whether the recipient can obtain the document within the same packaging unit, not whether the company once printed such a document.

1. Of the three elements, the place of business and the contact address cannot be merged or dropped. The provision lists name, place of business and contact address separately, yet a common practice in the field is to print only one email address or one web address. This does not match the text: the place of business points to an operating location that can be verified on the spot, while the contact address points to an address for deliverable communications, and the two functions differ. Art. 104a once allowed representative information to be stated on the accompanying documents rather than the label, but that transition expired on 31 July 2023 and can no longer serve as a basis for simplified labelling.

1. Labelling and verification are two independent lines of duty. Even with the three elements fully stated, failure to perform the five checks of Art. 53(1) remains a violation, and the reverse holds equally. What is easily missed is the cross between the first and the third check: the importer must verify that a CH-REP has been designated under Art. 51, which means the importer cannot rely on the oral assurance of the manufacturer and needs verifiable evidence. The checking cost that follows is precisely the hidden risk of handing the importer role to a pure logistics company.

4. Practical recommendations

1. Turn the three elements (name, place of business, contact address) into a standard labelling block placed with the device, the packaging or the accompanying documents; where accompanying documents carry the information, verify that the documents cannot separate from the device within the same distribution unit.
2. Build a written record template for the five checks of Art. 53(1) and execute it device by device or batch by batch; where a check fails, stop the placement under Art. 53(3) and keep the disposal records.
3. When verifying that a CH-REP has been designated under Art. 51, obtain documentary evidence of the written mandate rather than oral confirmation, and check the representative’s name against its CHRN (example CHRN-MF-23456789).
4. Where accompanying documents carry the importer information, handle the language question in step with Art. 16(2) — the product information must be written in the three official languages German, French and Italian, with a reduced language set only under the four conditions of Art. 16(3).
5. Before any repackaging or relabelling, first perform the notification duty under Art. 53(4) and have the quality system audited by a designated body.

5. Verification checklist

• □ The three elements — name, place of business, contact address — are complete and not replaced by an email or a web address
• □ The carrier (device / packaging / accompanying documents) has been selected, and an accompanying-documents solution has been verified as non-separable
• □ The five checks of Art. 53(1) have a written record template and are executed batch by batch
• □ Documentary evidence of the written mandate under Art. 51 has been obtained and the CHRN checked
• □ The language of the accompanying documents meets the three-language requirement of Art. 16(2) or the conditions of Art. 16(3)
• □ Repackaging/relabelling has been notified and the quality system audited by a designated body

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Swiss market end to end. For importer obligations GRZAN provides Swiss authorized representative (CH-REP) services, supplies verifiable mandate evidence for the Art. 51 check, reviews importer labelling blocks against the three elements of Art. 53(2) and the language rules of Art. 16(2), and builds fee budget models covering registration fees and hourly-based charges, keeping the cost of Swiss market entry predictable. For CH-REP appointment, importer compliance review or fee budgeting support for the Swiss market, contact info@grzanglobal.com.