Defining a Medical Device: MedDO Articles 1, 2 and Annex 1

This article is number 05 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

The starting point of characterisation is the scope provision in MedDO Art. 1(1) together with the exception list in Art. 2(1); Annex 1 separately lists the groups of products without a medical purpose that are nevertheless brought into regulation. A characterisation conclusion must be written as a sentence of legal source stating that the product is included or excluded on the basis of Art. X. Once characterisation goes wrong, the classification rules, the conformity assessment route and the transition period milestones all shift in sequence, and the error propagates through every downstream document until it is corrected at the source. Because regulators accept written reasoning but not verbal assurances, the quality of the characterisation file is what ultimately decides whether a Swiss submission moves forward without queries.

2. Legal basis

Verification entry points: MedDO Article 1, Article 2 and Annex 1, the list of products without a medical purpose, together with the Swissmedic pages on device characterisation. Reading the scope provision, the exception list and Annex 1 as a single set is essential, because each of the three texts answers a different question about the same product, and conclusions drawn from any one of them alone are incomplete.

3. Expert insights

1. Scope and exceptions must be read in pairs. Art. 1(1) defines the scope; Art. 1(3) brings into scope devices containing medicinal products, devices containing animal or human inactivated tissue, and devices containing an IVD component; Art. 2(1) then excludes blood products, living biological materials, IVDs and inseparable drug-device combinations. Conclusion: deciding from Art. 1 alone is a common error, and combination products with an IVD component are especially likely to move back and forth between the two provisions. Reading the scope and the exceptions as one integrated step is the discipline that prevents this. The trade-off: writing the exceptions as checklist items rather than background notes significantly reduces the rate of characterisation rework.
2. Products without a medical purpose are listed separately in Annex 1 and are not exempt for lacking a medical purpose. Conclusion: these products have no clinical evidence base to rely on, so their safety and performance must be demonstrated against the general safety and performance requirements of EU MDR Annex I as cited by MedDO Art. 6(1)(2). The counterpoint: arguing for exemption on the ground that no medical purpose means no risk does not stand once Annex 1 has expressly listed the groups; the real difficulty lies in comparing the product against each group item by item, not in debating whether it is a device at all. Annex 1 therefore functions as an inclusion list, and the demonstration burden runs in the opposite direction from what intuition suggests.
3. Characterisation is a serial step, not an isolated judgment. The characterisation result determines the classification rules; classification determines the conformity assessment route and the transition period milestones (MedDO high-risk devices until 31 December 2027, medium and low risk until 31 December 2028). Conclusion: investing at the characterisation stage costs far less than discovering a wrong route as the transition period draws to a close, when every downstream document built on the error must be revisited.

4. Practical recommendations

1. Use a three-part structure of provision, facts and conclusion for characterisation files: first cite Art. 1 or Art. 2, then list the product facts, then state the inclusion or exclusion conclusion.
2. For products containing medicinal substances, biological materials or an IVD component, issue a separate combination characterisation analysis that identifies the principal mechanism of action.
3. For products without a medical purpose, compare each item against the groups in Annex 1 and record the comparison result, avoiding conclusions by analogy.
4. Whenever a characterisation conclusion changes, review the classification, conformity assessment and transition period schedules at the same time.
5. Manage characterisation conclusions and their regulatory version dates within the design history file (DHF).

5. Verification checklist

• □ The scope under Art. 1(1)(3) and the exceptions under Art. 2(1) have been compared item by item
• □ Combination products have a defined principal mechanism of action and a written characterisation
• □ Products without a medical purpose have been compared group by group against Annex 1
• □ Characterisation conclusions state the version date of the cited regulation
• □ Characterisation conclusions have been propagated to classification, conformity assessment and transition period schedules
• □ Characterisation files are managed in the DHF with defined change triggers

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 device characterisation opinions under MedDO Art. 1 and Art. 2, combination product analyses, Annex 1 group comparisons for products without a medical purpose, and downstream alignment of classification and conformity assessment planning. Our team turns scope questions into defensible written conclusions. For tailored guidance on your product portfolio, contact info@grzanglobal.com.