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Regulation Statutory · EU

Regulation (EU) 2017/745 on medical devices.

Short answer

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. Since that date, Switzerland has been a third country for the EU, because the mutual recognition agreement (MRA) was not updated - Swiss manufacturers therefore need an authorised representative in the EU for the EU market. Software can itself be a medical device, and the MDR sets its own requirements on IT security for it in Annex I.

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01 Triggers

When does EU MDR apply to you?

EU MDR 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 - the MDR sets out how you must assess conformity, document and CE-mark it as soon as the product enters the market in the EU.
  • Industry: MedTech (Likely applies): As a MedTech company, you are highly likely to develop or distribute products that fall under the MDR's definition of a 'medical device' - check the classification based on your specific intended purpose.
  • Markets: EU, Germany (applies if additionally: Activity: Medical devices) (Recommend individual review): You are active on the EU market (or in Germany) and manufacture or distribute medical devices - even as a Swiss company, this makes you subject to the MDR. As a Swiss manufacturer, you additionally need an authorised representative in the EU since 26.5.2021.
  • Role towards customers: Manufacturer (applies if additionally: Activity: Medical devices) (Recommend individual review): As the manufacturer of a medical device, you bear the main responsibility under the MDR for conformity assessment, technical documentation, post-market surveillance and - if you are based in Switzerland and supply the EU - appointing an EU authorised representative. For manufacturers of other products, the MDR does not apply.

Exceptions

  • Custom-made devices (products individually made for a specific patient) are subject to adapted, reduced requirements instead of the full conformity assessment.
  • Pure in-vitro diagnostics do not fall under the MDR but under the separate IVDR (Regulation (EU) 2017/746).
  • For in-house manufacture and use of products within a health institution without supply to third parties, relief from certain MDR obligations applies under narrow conditions.
  • The exact article and paragraph numbers of these exemptions were not verified in this session via full-text retrieval from EUR-Lex (see 'unsicher').

02 Obligations

What does EU MDR require?

  • Carry out a conformity assessment procedure matching the product's risk class (Class I to III), including involving a notified body for higher classes.
  • Draw up and keep current technical documentation evidencing the product's design, manufacture and safety.
  • For software that is itself a medical device or embedded in one: meet the Annex I requirements on the design and manufacture of electronic programmable systems, including IT security measures and protection against unauthorised access, aligned with the state of the art.
  • Apply CE marking only after successful conformity assessment.
  • Operate post-market surveillance and a vigilance system (reporting of serious incidents).
  • As a Swiss manufacturer: appoint an authorised representative established in the EU before the product is placed on the market there.
  • Register the manufacturer, authorised representative and product in the EU database EUDAMED, to the extent the respective modules are already mandatory.

03 Evidence

What evidence is needed?

  • Technical documentation under Annex II/III of the MDR.
  • EU declaration of conformity.
  • CE marking with the notified body's identification number (where required).
  • Certificate from the notified body (for Class IIa, IIb, III and certain Class I products).
  • Evidence of an appointed EU authorised representative where based outside the EU, including the mandate document under Annex II of the MDR.

04 Deadlines

Which deadlines apply?

  1. The MDR (Regulation (EU) 2017/745) becomes applicable; from this date, Switzerland is treated as a third country by the EU in medical device law, because the MRA was not updated.

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?

The MDR itself does not prescribe uniform fines; EU member states set effective, proportionate and dissuasive sanctions for breaches in their national law. Market surveillance authorities can additionally order sales bans, recalls and withdrawal of CE marking. The exact enabling provision in the MDR was not verified via full-text retrieval in this session (see 'unsicher').

06 Related

What is connected with it?

07 Open

What is still uncertain?

  • The exact wording of Annex I section 17 of the MDR (subsections on IT security) could not be verified via full-text retrieval from EUR-Lex in this session - EUR-Lex blocked automated access (WebFetch and curl repeatedly returned empty responses with HTTP 202/404). The description rests on the website's existing content and established professional knowledge, not on a primary text read in this session.
  • The exact article number of the MDR's enabling provision for sanctions (presumably Art. 113) was not verified via full text.
  • The exact article/paragraph numbers of the exemptions named (custom-made devices, IVDR demarcation, in-house manufacture) were not verified via full-text retrieval.
  • The exact title and content of the 'Notice to Stakeholders' on the Switzerland-EU MRA status, mentioned by the European Commission, could not be retrieved directly (404 at the presumed URL); its existence is evidenced via the health.ec.europa.eu page, not its wording.

08 Sources

Sources

Information as of: 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 EU MDR.

We are a Swiss manufacturer and sell only in Switzerland - does the MDR affect us?

Not directly, as long as you operate exclusively on the Swiss market; there, the MedDO applies. As soon as you place a product on the market in the EU, the MDR applies and you need an authorised representative in the EU.

Is our software automatically a medical device?

No, that depends on the intended purpose. Software used for medical purposes such as diagnosis, monitoring or treatment support can itself qualify as a medical device and must then meet the MDR's requirements, even if it is not a hardware component.

What does Switzerland's third-country status specifically mean for us as a manufacturer?

Since 26.5.2021 you need an authorised representative established in the EU to represent your products there, and you no longer have direct access to the EU database EUDAMED or to the information exchange of European authorities. At the same time, EU manufacturers supplying Switzerland must appoint a Swiss authorised representative.

Does EU MDR 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.

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