Setting up a medical device company in Switzerland: device classes, Swiss authorised representative, CHRN registration and notified bodies

No licence, but conformity before the first sale

A medtech business plan starts with a qualification question: is the product a medical device at all? The Medical Devices Ordinance (MedDO) covers “instruments, apparatus, appliances, softwares, implants, reagents, materials or other articles” intended by the manufacturer for use on human beings that “do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means” and that serve a medical purpose such as diagnosis, monitoring, treatment or the replacement of an anatomical structure (Art. 3 MedDO). A diagnostic support software can therefore be a medical device, while a product acting pharmacologically is a medicinal product.

The regulatory consequence is stated plainly on the Swissmedic medical devices page: “Unlike medicinal products, medical devices do not undergo an official authorisation procedure. Swissmedic’s focus in the area of medical devices is thus on effective market surveillance.” Surveillance, however, is not permission. Under Art. 6 para. 1 MedDO, “A device may be placed on the market or put into service only if it complies with this Ordinance when duly supplied and properly installed, maintained and used in accordance with its intended purpose.”

Swissmedic adds that the conformity requirement “also applies to medical devices and IVD that are given away free of charge, rented or used directly”, so demonstration loans and rental models are caught as well. In vitro diagnostic devices follow a parallel ordinance (IvDO) with classes A to D and the same logic of representative and registration. If your project also involves medicinal products, our guide to starting a pharmaceutical company in Switzerland covers the establishment licence and the responsible person.

Medical device classification: invasive or not

Art. 15 MedDO sets the framework: “Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks.” The same article makes Annex VIII to the EU Medical Device Regulation (EU-MDR, Regulation 2017/745) the rulebook. Swissmedic’s FAQ is explicit about who decides: “It is the responsibility of the manufacturer to correctly classify his devices.” Classification is a documented company decision, reviewed by a notified body where one is involved, not a label handed out by the authority.

Invasive, implantable, transient: the vocabulary that sets the class

The EU-MDR defines an invasive device as “any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body”. An implantable device is intended to be totally introduced into the body and to remain there after the procedure, or partially introduced and left in place for at least 30 days. Duration is measured in three bands: “‘Transient’ means normally intended for continuous use for less than 60 minutes”, “short term” covers continuous use between 60 minutes and 30 days, and “long term” continuous use for more than 30 days.

Self-declaration in class I, notified body above

For class I, the EU-MDR lets manufacturers “declare the conformity of their products by issuing the EU declaration of conformity” once the technical documentation is drawn up (Art. 52 para. 7 EU-MDR). A notified body still steps in, limited to those aspects, where the class I device is sterile, has a measuring function or is a reusable surgical instrument. From class IIa upwards, a third party is mandatory. Swissmedic explains that “A designated body (Swiss term) is the same as a notified body (EU term)” and that these bodies “carry out conformity assessment procedures for all devices classified outside the lowest risk classification”.

The list published by Swissmedic then contains a sentence every Swiss medtech founder should read before drafting a budget: “As of 1 April 2025, there are no designated bodies in Switzerland.” Foreign bodies are listed in the European NANDO database. A Swiss manufacturer of a class IIa, IIb or III invasive device therefore contracts with a notified body established in the EU, whose identification number must accompany the conformity marking (Art. 13 para. 3 MedDO). Waiting times and fees of that body belong in the financing plan, well before incorporation.

Four economic operators and their duties

The MedDO distributes obligations among four economic operators. A single company can hold several roles at once, and the role follows what the company actually does, not the wording of its corporate purpose.

The manufacturer definition catches many founders off guard. A start-up that has its device produced by a contract manufacturer in Europe or Asia and sells it under its own brand is the manufacturer in law, with every obligation that goes with it. Art. 49 MedDO requires manufacturers to “have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices”, with a deputy, and that person “must suffer no disadvantage” for doing the job properly, employee or not. Micro and small enterprises may rely on an external PRRC, provided they “have such person permanently and continuously at their disposal” (Art. 15 para. 2 EU-MDR).

Two answers from the Swissmedic FAQ matter for international groups. The MedDO does “not define a requirement for the PRRC to be domiciled in the same jurisdiction” as the manufacturer or representative, as long as the person is organisationally and professionally integrated over the long term. And the possibility that the PRRC of the Swiss representative is also the PRRC of an EU representative or of the manufacturer “is not ruled out”. A group can therefore pool this expertise, provided each entity can demonstrate genuine access to it.

CHRN and swissdamed: registration requires a Swiss entity

Art. 55 MedDO obliges “Manufacturers or their authorised representatives and importers” to register the required information with Swissmedic “before placing a device on the market for the first time”. Changes must be reported “within one week”, and Swissmedic then assigns each operator “a Swiss single registration number (CHRN)”.

The Swissmedic CHRN page answers a practical question that most English-language checklists skip: “Evidence of domicile in Switzerland (i.e. extract from the commercial register or certificate of residence) must be attached to the application.” The number takes the form CHRN, a role code and eight digits, for example CHRN-MF-23456789, and “is issued to Swiss manufacturers, authorised representatives and importers, as well as to manufacturers of systems and procedure packs”. Applications go through the Actors module of swissdamed. In other words, the company exists and is entered in the commercial register before it can register.

• Device registration: according to Swissmedic, registration of devices, systems and procedure packs “will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026”, replacing the former notification obligation.
• UDI: the manufacturer assigns a unique device identifier to the device and to every higher packaging level before placing it on the market and keeps the list in the technical documentation (Art. 17 MedDO); Swissmedic notes that the device information held in UDI databases “is publicly available”.
• Fees: notifications under Art. 18, 19, 53, 54, 103 and 108 MedDO attract a fee of CHF 300 per notification under the Swissmedic fees ordinance.
• Languages: product information must be written in the three official languages; fewer languages or English alone are possible only where, among other conditions, the device is supplied exclusively to healthcare professionals who agree to it (Art. 16 MedDO).
• Liechtenstein: under the 1923 customs treaty, operators based in Liechtenstein may act in Switzerland and must also register with Swissmedic; Liechtenstein manufacturers do not need a Swiss representative.

The Swiss authorised representative (CH-REP) as a business

Art. 51 para. 1 MedDO is the rule that brings most foreign manufacturers to Switzerland: “Where the manufacturer of a device is not domiciled in Switzerland, the device may only be placed on the market if the manufacturer designates an authorised representative domiciled in Switzerland by means of a written mandate.” It applies to manufacturers in the EU as much as to those in the United Kingdom, the United States or Asia. The representative, commonly called CH-REP, “is responsible for the formal and safety-related aspects of placing the device on the market” (Art. 51 para. 2), and its rights and duties mirror those of an EU authorised representative under Art. 11 EU-MDR.

• Scope of the mandate: Swissmedic states that the designation “shall be effective at least for all devices of the same generic device group”, so a manufacturer cannot split one product family across several representatives.
• Technical documentation: the manufacturer may undertake to send its documentation straight to Swissmedic on request, in which case “The authorised representative must ensure that the documentation is submitted within seven days” (Art. 51 para. 4).
• Expertise: the representative must have “permanently and continuously at their disposal” a person responsible for regulatory compliance (Art. 52).
• Labelling: “The name and address of the authorised representative must appear adjacent to the symbol”, and Swissmedic adds that “It is not sufficient only to state the P.O. box number, an e-mail address or a telephone number”. Instead of the symbol, “CH authorised representative”, “CH-REP” or “Authorised representative for Switzerland” may be written.
• Importer: a separate role. Before placing a device on the market, the importer verifies among other things that the manufacturer “has designated an authorised representative in accordance with Article 51”, and indicates its own “name, place of business and the address at which they can be contacted” on the device, its packaging or an accompanying document (Art. 53).

Switzerland as a third country: CE marking, deadlines and FDA devices

The Federal Office of Public Health (FOPH) sums up the situation: “Until 2021, a Mutual Recognition Agreement (MRA) between the EU and Switzerland guaranteed mutual market access. However, the EU has not updated the MRA since then because it is linking this step to the clarification of institutional issues between Switzerland and the EU. Switzerland is therefore currently treated as a third country, but unilaterally recognises EU conformity assessments.”

Entering Switzerland: the European route remains open

Under Art. 13 para. 1 MedDO, “The conformity marking presented in Annex V to EU-MDR is also a permissible conformity marking.” Certificates issued by bodies designated under EU law and domiciled in the EU or EEA are deemed equivalent to Swiss certificates where the procedures and the body’s qualifications meet Swiss requirements (Art. 25 para. 4 MedDO). For a manufacturer in the United States or Asia, the practical path to Switzerland for devices above class I therefore runs through an EU notified body and a CE marking, combined with a Swiss representative and importer. For devices certified under the former EU directives, the FOPH lists transitional periods until 31 December 2027 for higher-risk devices and until 31 December 2028 for medium and lower-risk devices.

Leaving Switzerland: an EU representative for Swiss manufacturers

The mirror image applies to Swiss companies. Art. 11 para. 1 EU-MDR provides that “Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.” A Swiss medtech company aiming at European hospitals budgets for both an EU notified body, above class I, and an authorised representative established in a Member State.

FDA-approved devices: guidelines, not yet law

Parliament has instructed the Federal Council to take non-European regulatory systems into account. The FOPH communication of 30 April 2025 explains that “Implementation is currently focused on medical devices approved by the US Food and Drug Administration (FDA)” and that “the Federal Council defined guidelines and will assign responsibility for controls to private bodies”. No legal text and no date of entry into force have been published. A business plan that assumes FDA clearance alone will open the Swiss market rests, for now, on a policy direction.

Clinical investigations: category A or category C

Many medtech projects need clinical data generated in Switzerland. The Ordinance on Clinical Trials with Medical Devices (ClinO-MD) defines a clinical investigation as “any systematic investigation involving one or more persons undertaken to assess the safety or performance of the device” (Art. 2 ClinO-MD). The applicable procedure turns on the status of the device.

• Category A: the device carries a conformity marking, is used in accordance with its instructions for use and is not prohibited in Switzerland (Art. 6). “Category A clinical trials are exempt from the requirement to obtain approval from Swissmedic” (Art. 7); the ethics committee remains competent.
• Category C: the marked device is used outside its instructions for use (C1), carries no conformity marking (C2) or is prohibited in Switzerland (C3). Swissmedic approval is then required in addition to the ethics committee.

The sponsor is the person or institution “that takes responsibility for organising a clinical trial” in Switzerland, specifically its initiation, management and financing (Art. 2 ClinO-MD). Whether the Swiss company or its foreign parent is the sponsor affects contracts with hospitals, insurance cover and the way trial costs are booked and financed.

Legal form, customs and VAT for a medtech company

A medical device company expecting outside investors is usually incorporated as a company limited by shares (AG/SA), which our guide to the public limited company in Switzerland explains; a representative or importer of modest size often works as a limited liability company (GmbH/Sàrl). Because the MedDO refers to a person domiciled in Switzerland, foreign groups that want to keep the representative or importer role within the group often establish a Swiss subsidiary rather than rely on a third-party distributor. The incorporation steps are set out in our guide to company incorporation in Switzerland.

• Customs: since 1 January 2024, Switzerland has abolished import duties on industrial goods in chapters 25 to 97 of the Harmonised System, which include medical instruments and apparatus. Customs declarations and import VAT remain, as our article on Swiss customs duties explains.
• VAT rate: the reduced rate of 2.6% covers “medication” (Art. 25 para. 2 VAT Act); medical devices are taxed at the standard rate of 8.1%. Medical treatment is excluded from VAT, but the law specifies that “The dispensing of self-manufactured or bought-in artificial limbs and orthopaedic equipment is deemed to be a taxable supply of goods” (Art. 21 para. 2 VAT Act). Our overview of VAT in Switzerland gives the general rules.
• Foreign sellers: a manufacturer based abroad that supplies Swiss customers directly may itself become liable for Swiss VAT, in which case it acts through a tax representative for VAT in Switzerland.
• Accounting: UDI, traceability and post-market surveillance require stock records by reference and batch, and sales data kept in a form that feeds the manufacturer’s safety reporting. These tasks sit within our administration services for Swiss companies.

Where medical device projects go wrong

• Reading “no authorisation” as “no control”: a device is sold only after its conformity assessment is complete, and Swissmedic runs market surveillance, focus campaigns and inspections.
• Underestimating the class: surgically invasive devices and diagnostic decision software generally leave class I, which means an EU notified body, since none remains in Switzerland.
• Private label without the obligations: selling a contract-manufactured device under your own brand while believing you are a distributor.
• A representative in name only: appointing, or becoming, a CH-REP without a PRRC available at all times and without a process for the seven-day documentation request.
• Counting on FDA recognition: the Federal Council has published guidelines, not rules in force.
• Forgetting the timetable: device registration in swissdamed has been mandatory since 1 July 2026, with a transition period ending on 31 December 2026.

FAQ: starting a medical device company in Switzerland

Do I need a licence from Swissmedic to sell medical devices in Switzerland?

No. Medical devices do not undergo an official authorisation procedure. The device must, however, have completed its conformity assessment before it is placed on the market, and Swiss manufacturers, authorised representatives and importers must register with Swissmedic beforehand.

Is every invasive medical device class II or III?

No. A device invasive through a body orifice and intended for transient use, meaning less than 60 minutes of continuous use, is in principle class I, as are reusable surgical instruments. Surgically invasive and implantable devices generally fall into classes IIa, IIb or III, depending on duration of use and the part of the body concerned.

Does a manufacturer based in the EU, the UK or the US need a Swiss authorised representative?

Yes. A manufacturer not domiciled in Switzerland can only place devices on the Swiss market after designating, by written mandate, an authorised representative domiciled in Switzerland (Art. 51 MedDO). Manufacturers based in Liechtenstein are the exception under the customs treaty.

Can a foreign company obtain a CHRN?

The CHRN is issued to Swiss manufacturers, authorised representatives and importers, and the application must include evidence of domicile in Switzerland, such as a commercial register extract. A foreign manufacturer is therefore registered through its Swiss representative, or through its own Swiss subsidiary if it creates one.

Must the PRRC live in Switzerland?

Not necessarily. Swissmedic indicates that the MedDO does not require the PRRC to be domiciled in the same jurisdiction as the manufacturer or representative, provided the person is integrated over the long term and actually performs the tasks. The same person may also act for the manufacturer and for the Swiss representative.

Are CE-marked or FDA-approved devices accepted in Switzerland?

CE-marked devices are accepted, since Switzerland unilaterally recognises EU conformity assessments. For FDA-approved devices, the Federal Council has only defined guidelines, published on 30 April 2025, and no rules are in force yet.

Sources

• Medical Devices Ordinance (MedDO, SR 812.213), Art. 3, 4, 6, 13, 15 to 17, 25, 49, 51 to 55
• Regulation (EU) 2017/745 on medical devices, Art. 2, 11, 15, 52 and Annex VIII
• Swissmedic, Medical devices
• Swissmedic, Market access
• Swissmedic, Registering economic operators (CHRN)
• Swissmedic, Notification and registration of medical devices
• Swissmedic, Unique Device Identifiers (UDI)
• Swissmedic, Swiss authorised representative (CH-REP)
• Swissmedic, Designated bodies
• Swissmedic, Frequently asked questions on medical devices
• Federal Office of Public Health, Medical devices (30 April 2025)
• Federal Office of Public Health, Legislation on medical devices (in French)
• Ordinance on Clinical Trials with Medical Devices (ClinO-MD, SR 810.306), Art. 2, 6 and 7
• Federal Act on Value Added Tax (VAT Act, SR 641.20), Art. 21 and 25
• State Secretariat for Economic Affairs, Abolition of industrial tariffs (in French)