IVD Regulation under IvDO: Class A to D and Conformity Assessment

This article is number 07 in Volume 1, Regulatory Framework and Fundamentals, of the fifty-part series on medical device registration in Switzerland. Together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, article title and unique URL are listed in the table below.

1. Key takeaways

In vitro diagnostic devices are not governed by MedDO but regulated separately by the Ordinance on In Vitro Diagnostic Medical Devices (IvDO, SR 812.219): they are classified A, B, C and D, and conformity assessment is completed through IvDO Art. 19 in combination with EU IVDR Art. 48(3)(4). Transition periods run in three tiers to December 2027 for Class D, December 2028 for Class C, and December 2029 for Class B and sterile Class A. IVD product lines must therefore maintain their own timeline; the two MedDO milestones cannot be reused, and applying them to IVD products either creates false urgency or hides real deadlines. A single merged calendar with colour-coded lines per ordinance is the simplest control against this mismatch.

2. Legal basis

Verification entry points: IvDO (SR 812.219) Articles 15, 19 and 48 and the annex classification rules; the amendment of 20 November 2024 (AS 2024 742, in force since 1 January 2025). Because the amendment changed registration obligations without touching MedDO, any IVD project file should cite the amendment explicitly so that reviewers can see which version of the obligations is being applied.

3. Expert insights

1. Classification determines when the third party steps in. Conformity assessment is completed through IvDO Art. 19 in combination with IVDR Art. 48(3)(4). Conclusion: the higher the class, the earlier and the less avoidably a designated conformity assessment body becomes involved; preparing a high-class product along a low-class route leads to a wholesale return at the designated step, and the rework cycle is longer than expected. The trade-off: confirming the class early matters more than submitting documents early, because a wrong route invalidates the entire submission. A short written classification rationale, agreed before dossier assembly begins, is cheaper than any rework after a return.
2. The open-ended nature of Art. 87 gives certain product lines a stable expectation. The simplified designation requirements for non-self-test IVDs apply indefinitely from 1 January 2025. conclusion: indefinite validity supports long-term product planning, but the precondition is non-self-test use, and that boundary must be defined first; misapplying the simplified requirements directly affects the legality of the conformity assessment and is an error that can hardly be remedied afterwards. The written justification should therefore be approved by the quality function, not only by regulatory affairs.
3. The three transition tiers are not synchronised with MedDO. Class D runs to December 2027, Class C to December 2028, and Class B and sterile Class A to December 2029; on the MedDO side, high-risk devices run until 31 December 2027 and medium and low risk until 31 December 2028. Conclusion: companies holding both product lines should build a merged timeline, otherwise it is easy to misapply the MedDO date of 31 December 2028 to IVD Class B and sterile Class A products, giving up transition windows that were in fact available. The cost of that error is not only rushed submissions; it is certificates obtained late and product lines that stand still on the Swiss market while the paperwork catches up.

4. Practical recommendations

1. Maintain a separate transition period calendar for the IVD product line and never share one table with the device product line.
2. Record the classification conclusion in writing, mapped to the corresponding provisions of IvDO and IVDR Art. 48, with the regulatory version date noted.
3. For products intended to use the Art. 87 simplified designation requirements, first document the non-self-test character in writing and retain it.
4. Schedule device registration around the mandatory date of 1 July 2026; IVDs and devices share the same swissdamed process, so one training session can cover both teams if the examples cover both product types.
5. Appoint vigilance owners for IvDO Art. 58–60 separately from the device line, to prevent confusion in reporting paths.

5. Verification checklist

• □ It is confirmed that the product falls under IvDO rather than MedDO (Art. 2 exception)
• □ The A to D classification conclusion is recorded in writing with the regulatory version date
• □ Transition period end points are locked by the D/C/B and sterile A tiers
• □ Products intending to use Art. 87 have a documented non-self-test justification
• □ swissdamed device registration is scheduled against the 1 July 2026 milestone
• □ A separate vigilance owner for IVDs has been appointed

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers and economic operators entering the Swiss market with end-to-end Swissmedic registration and compliance services, including IVD classification under the IvDO A to D scheme, conformity assessment route planning through IvDO Art. 19 and IVDR Art. 48, non-self-test justifications for Art. 87, and merged timelines for companies holding both device and IVD lines. For tailored guidance on your product portfolio, contact info@grzanglobal.com.