Regulation Statutory · Switzerland
Medical Devices Ordinance of 1 July 2020 (SR 812.213).
The Swiss Medical Devices Ordinance (MedDO, SR 812.213) governs the manufacture, placing on the market and surveillance of medical devices in Switzerland and is supervised by Swissmedic. It was brought into force in a completely revised version on 26 May 2021 and closely follows the substance of the EU MDR (Regulation (EU) 2017/745), but remains independent Swiss law with its own authorisation, registration and supervisory logic via Swissmedic instead of EU authorities.
01 Triggers
When does MedDO apply to you?
MedDO may apply to you if one of these triggers applies. The Regulatory Check tests them against your details.
- Activity: Medical devices (Applies): You manufacture, import or distribute a medical device in Switzerland - the MedDO sets out which conformity evidence, registrations and notifications you must provide to Swissmedic.
- Markets: Switzerland (applies if additionally: Activity: Medical devices) (Recommend individual review): You are active on the Swiss market and manufacture, import or distribute medical devices - for this, the MedDO applies to you under Swissmedic's supervision, regardless of whether you are also active in the EU.
- Industry: MedTech (Likely applies): As a MedTech company with Swiss market relevance, you are highly likely to fall under the MedDO - check the classification of your product based on its intended purpose.
- Role towards customers: Manufacturer, Distributor (applies if additionally: Activity: Medical devices) (Recommend individual review): As a manufacturer or distributor of medical devices in Switzerland, you have your own obligations under the MedDO, including registration with Swissmedic (Swiss Single Registration Number, CHRN) and appointing a Swiss authorised representative if you are based abroad.
Exceptions
- Custom-made devices and manufacturing-specific regulated exemptions carry, analogous to the MDR, adapted rather than full conformity requirements.
- For products already lawfully placed on the market under the old law before the revised MedDO applied, transition periods existed; whether and for which product categories these are still relevant in September 2026 was not verified in this session.
- The exact article and paragraph numbers of these exemptions were not verified via full-text retrieval from Fedlex (see 'unsicher').
02 Obligations
What does MedDO require?
- Carry out conformity assessment and classify the product by risk class, substantively aligned with the MDR system.
- Draw up technical documentation and make it available to Swissmedic on request.
- As manufacturer, authorised representative or importer: register with Swissmedic and obtain a Swiss Single Registration Number (CHRN).
- As a foreign manufacturer with no seat in Switzerland: appoint an authorised representative established in Switzerland who carries out the regulatory obligations towards Swissmedic (mirroring the obligation of Swiss manufacturers to appoint an EU authorised representative).
- Operate a vigilance system and report serious incidents to Swissmedic.
- Ensure post-market surveillance and keep the product file current.
03 Evidence
What evidence is needed?
- Technical documentation per the requirements set out in the MedDO, aligned with the MDR.
- Manufacturer's declaration of conformity.
- Swiss Single Registration Number (CHRN) for manufacturers, authorised representatives and importers.
- Certificate from a conformity assessment body, where required for the risk class.
- Evidence of an appointed Swiss authorised representative where the manufacturer's seat is outside Switzerland.
04 Deadlines
Which deadlines apply?
- Entry into force of the completely revised MedDO (enactment date of the ordinance: 1 July 2020) and of the new ordinance on clinical trials with medical devices; simultaneously the start of Switzerland's third-country status towards the EU in medical device law.
Information as of: 24 September 2026. Past dates are grey, upcoming ones highlighted (as of when the page was built).
05 Penalties
What are the consequences of violations?
Breaches of the MedDO are penalised via the penal provisions of the Therapeutic Products Act (TPA); depending on severity and intent, the range extends to imprisonment or fines. In addition, Swissmedic as the supervisory authority can order sales bans, recalls and withdrawal of registrations or licences. The exact article numbers of the TPA were not verified via full text in this session (see 'unsicher').
06 Related
What is connected with it?
- Regulation (EU) 2017/745 on medical devices: The EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) governs conformity assessment, CE marking, technical documentation and market surveillance for medical devices in the EU; it has applied since 26 May 2021.
- ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes: ISO 13485 is the international standard for quality management systems specifically for medical device manufacturers.
- IEC 62304 – Medical device software – Software life cycle processes: IEC 62304 sets out how you must safely develop and maintain software for medical devices across the entire life cycle - planning, requirements, architecture, implementation, verification, release, maintenance.
- General Data Protection Regulation: The EU General Data Protection Regulation (Regulation (EU) 2016/679) has applied since 25 May 2018 and governs the processing of personal data in the EU.
- Federal Act on Data Protection (Data Protection Act, FADP): The revised Federal Act on Data Protection (FADP, SR 235.1) has, since 1 September 2023, governed the processing of personal data of natural persons by private companies and federal bodies in Switzerland.
07 Open
What is still uncertain?
- The full text of the MedDO on Fedlex (SR 812.213) could not be read in an automated way in this session: Fedlex serves bots only the JavaScript application shell (WebFetch and several curl variants, including guessed filestore paths, returned identical empty shell pages). The substantive statements rest on the Swissmedic notice of 26.5.2021 (authority source, read in full text) and the Swissmedic factsheet on the obligations of economic operators, not on the ordinance's text itself.
- The exact article numbers on transition periods for legacy products, and on the penal provisions in the TPA, were not verified via full text.
- Whether and which transition periods from the 2020/2021 revision are still actively relevant in September 2026 was not examined.
08 Sources
Sources
Information as of: 24 September 2026.
- Medizinprodukteverordnung vom 1. Juli 2020 (MepV, SR 812.213), Schweizerischer Bundesrat / Fedlex (Systematische Rechtssammlung des Bundes), retrieved on 24 September 2026
- AS 2021 281 – Änderung der Medizinprodukteverordnung, Fedlex, Amtliche Sammlung des Bundesrechts, retrieved on 24 September 2026
- Neue Regulierung der Medizinprodukte ab 26. Mai 2021, Swissmedic, retrieved on 24 September 2026
- Merkblatt: Pflichten der Wirtschaftsakteure in der Schweiz (MU600_00_016d), Swissmedic, retrieved on 24 September 2026
A professional assessment based on publicly available sources, not legal advice. Whether a given rule applies in your specific case depends on circumstances that are not fully captured here.
FAQ Answers
Questions about MedDO.
Is CE marking under the EU MDR sufficient to sell in Switzerland?
Not automatically as a full substitute for the Swiss obligations: you additionally need a Swiss authorised representative (if based abroad) and registration with Swissmedic. In substance, the MedDO closely follows the MDR, but it is independent Swiss law with its own registration logic.
Who supervises compliance with the MedDO?
Swissmedic, the Swiss Agency for Therapeutic Products. It carries out market surveillance, receives vigilance reports, and issues the Swiss Single Registration Number (CHRN).
What does 'substantively aligned with the MDR' specifically mean?
Switzerland has largely adopted the substantive requirements of the EU MDR into its own law, to maintain equivalence and make later EU market access easier for Swiss manufacturers. Legally, however, it is an independent Swiss ordinance with its own supervision, not a direct application of the EU MDR.
Does MedDO apply to you?
The Regulatory Check gives an initial assessment. In a conversation, we clarify what really applies in your situation and in which order you address it.
