IvDO Art. 87: the simplified designation requirements for non-self-test IVDs made permanent

This article is part of the 50-article series on medical device registration in Switzerland, Volume 2 (Premarket Pathways and Strategy), and is the seventeenth instalment; together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, title and unique URL are shown in the table below.

1. Key takeaways

The simplified designation requirements for non-self-test in vitro diagnostic devices under Art. 87 of the IvDO have applied without time limit since 1 January 2025 — this is not yet another extension but the conversion of a temporary arrangement into a standing rule. Assessing applicability takes a single step: determine whether the product is a non-self-test IVD. Self-test and near-patient testing products fall outside the stated scope of this provision and cannot borrow it. Companies should therefore read Art. 87 not as a transitional relief measure that will soon disappear, but as a durable feature of the Swiss IVD landscape around which product information, labelling and designation arrangements can be designed for the long term. The permanence also simplifies portfolio planning: one rule set for all non-self-test IVDs, with no cliff-edge date to manage around.

2. Legal basis

3. Expert insights

1. Indefinite validity and a transition period follow two different logics, and neither can serve as an excuse for the other. Art. 82(1) governs the transition for legacy IVDs (Class D to December 2027, Class C to December 2028, Class B and sterile Class A to December 2029), while Art. 87 governs the simplified designation requirements for non-self-test IVDs. Art. 87 has had no end date since 1 January 2025, meaning it does not lapse when the transition periods end; conversely, the permanence of Art. 87 gives no reason to expect the transition calendar to slide.
2. The policy meaning of permanence is that compliance costs can be spread. A simplified arrangement with an expiry date only justifies a minimal, stop-gap investment; once it becomes indefinite, it becomes rational to restructure product information, labelling and designation arrangements on a long-term basis. The counterweight is that the regulator no longer feels pressure to tighten as a deadline approaches, so if the provision is ever amended, the direction is more likely to be stricter than looser.
3. The same amendment opened the device registration obligations. The amendment of 20 November 2024 (AS 2024 742) made the simplified designation requirements permanent and, at the same time, introduced device registration obligations; on the MedDO side these are carried by Art. 108, replacing the former notification obligation with swissdamed registration from 1 July 2026. IVD manufacturers therefore face a two-sided change — designation requirements simplified, registration requirements tightened — and focusing only on the former means missing the latter.
4. The qualifying word in the scope is non-self-test. The provision is expressly limited to non-self-test IVDs. Self-test devices are directed at lay users, and the regulatory logic of their product information and designation arrangements differs from the professional setting; no equivalent simplification can be inferred from Art. 87 for them (practical estimate).

4. Practical recommendations

1. Add a non-self-test field to the IVD product ledger as the determinant of Art. 87 applicability, recording the conclusion and reasoning item by item.
2. Manage CHRN registration on the IVD side under Art. 48 on the same logic as Art. 55 on the MedDO side: register within 3 months of first placing on the market and report changes within 1 week.
3. Plan UDI-DI record building against the mandatory registration regime from 1 July 2026, budgeting CHF 200 for the first UDI-DI and CHF 20 for each additional one within the same year.
4. Schedule the conformity assessment route under Art. 19 combined with Art. 48(3)(4) of the IVDR separately, and do not conflate it with the simplified designation requirements of Art. 87.
5. Establish the quality system with ISO 13485 as one of its baselines and retain certification evidence covering IVD design, production and post-market activities.

5. Verification checklist

• □ For every IVD it has been determined whether it is non-self-test, and the Art. 87 applicability conclusion is recorded.
• □ It is confirmed that Art. 87 applies without time limit from 1 January 2025 and has not been mixed up with the Art. 82(1) transition periods.
• □ CHRN registration on the IVD side (Art. 48) and the 1-week change reporting mechanism are in place.
• □ The scope of mandatory swissdamed registration from 1 July 2026 covers all IVDs on sale.
• □ The registration fee budget reflects CHF 200 for the first UDI-DI and CHF 20 per addition.
• □ Quality system certification (ISO 13485 and similar) is within its validity period.

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers entering the Swiss market with registration pathway and classification strategy services, including IVD scope triage under Art. 87 of the IvDO and CHRN and swissdamed registration planning. For support with your Swiss IVD portfolio, contact GRZAN at info@grzanglobal.com.