How large is the Swiss medtech sector?
What is a medical device?
Under the Medical Devices Ordinance (MepV, SR 812.213) a medical device is an item intended for a medical purpose whose principal action is not pharmacological, immunological or metabolic. Unlike medicinal products, devices are not authorised by Swissmedic: conformity assessment applies, with a designated body involved for the higher classes.
Swiss Medtech, the industry association, puts the sector at roughly 1400 companies and several tens of thousands of employees in its industry study, with an export share far above the Swiss industrial average. These are association figures and should be read as an order of magnitude, not as federal official statistics.
The structure is characteristic. According to Swiss Medtech about 95 percent of the businesses are SMEs. Alongside a handful of global groups, hundreds of suppliers with twenty to two hundred employees work as contract manufacturers for micromechanics, injection moulding, laser welding, sterile packaging or surface coating.
Value is created by precision, not by volume. High wages push mass-market articles out of the country; what remains are parts with micrometre tolerances, implantable materials, hearing-aid electronics and injection systems in which Swiss suppliers hold meaningful global market shares.
The customer base sits almost entirely abroad. The EU remains the most important buyer, followed by the United States. That is precisely why European regulatory change bites harder in Switzerland than in many neighbouring countries: domestic demand cannot carry a sector of this shape.
Which regions form the clusters?
The sector concentrates in six areas: Bern and Solothurn for injection and implant technology, the Jura arc for microtechnology, Zurich and Winterthur for hearing systems and electronics, the Lake Geneva region around EPFL, Basel for dental and osteosynthesis, plus Eastern Switzerland and Ticino.
Bern and Solothurn form the most visible pole. Ypsomed in Burgdorf builds insulin pens and autoinjectors and also acts as a contract manufacturer for pharmaceutical customers; Mathys in Bettlach makes hip and knee prostheses, and the same municipality hosts a long-established osteosynthesis plant that today belongs to Johnson and Johnson MedTech.
The Jura arc in Neuchâtel, Jura and the Bernese Jura has completed the move from watchmaking to medical devices. Turning, milling and grinding to hundredths, precious-metal processing and cleanroom assembly were already in place; today screw heads, catheter components and dental parts run there instead of movements alone.
Around EPFL in Lausanne and in Geneva sits the research-facing part: neurotechnology, microfluidics, ophthalmology. Basel contributes dental implants and osteosynthesis, Zurich hearing systems and electronics, Eastern Switzerland and Graubünden ventilation, implants and technical textiles, Ticino orthopaedics and supplier work.
| Region | Specialisation | Example companies |
|---|---|---|
| Bern and Emmental | Injection systems, insulin pens, diabetes technology | Ypsomed (Burgdorf), Ypsomed Solutions |
| Solothurn, Grenchen, Bettlach | Orthopaedics, osteosynthesis, precision parts | Mathys (Bettlach), Johnson and Johnson MedTech (Bettlach) |
| Jura arc (NE, JU, Bernese Jura) | Microtechnology, machining, watchmaking know-how | Cendres+Métaux (Biel), suppliers in Le Locle and Delémont |
| Zurich and Winterthur | Hearing systems, electronics, medical robotics | Sonova (Stäfa), Zimmer Biomet (Winterthur) |
| Lausanne and Geneva (EPFL axis) | Neurotechnology, microfluidics, ophthalmology | Debiotech (Lausanne), Alcon (Geneva) |
| Basel and Basel-Landschaft | Dental implants, osteosynthesis, diagnostics | Straumann (Basel), Medartis (Basel) |
| Eastern Switzerland and Graubünden | Ventilation, implants, technical textiles | Hamilton Medical (Bonaduz), Sefar (Thal) |
| Ticino | Orthopaedics, micromechanical suppliers | Medacta (Castel San Pietro), regional contract manufacturers |
What did the MDR change, and why did the MRA chapter lapse?
Regulation (EU) 2017/745 on medical devices (MDR) has applied in the EU since 26 May 2021, and Regulation (EU) 2017/746 on in vitro diagnostics (IVDR) since 26 May 2022. On that same 26 May 2021 the medical devices chapter of the Mutual Recognition Agreement on conformity assessment (MRA) ceased to have effect.
The chapter would have needed updating to the MDR. Because the EU tied that update to the institutional framework agreement, which collapsed in 2021, Switzerland became a third country in device law. The two systems no longer recognise each other automatically, even though Switzerland has mirrored the MDR substantively in the MepV.
The consequence is dual representation. A Swiss manufacturer needs an EU Authorised Representative and an EU importer for the European market; a manufacturer from the EU or a third country needs a Swiss authorised representative (CH-REP) for the Swiss market under the MepV and, for in vitro diagnostics, under the IVD Ordinance (IvDV, SR 812.219).
Registration duties come on top. Economic operators register with Swissmedic and receive a CHRN, products are recorded in the swissdamed database, and the unique device identification UDI must be traceable on labelling and in the documentation. The transition deadlines for appointing a CH-REP expired during 2021 and 2022, staggered by risk class.
- 26 May 2021: MDR (EU) 2017/745 applicable, and the MRA chapter for medical devices lapsed the same day
- 26 May 2022: IVDR (EU) 2017/746 applicable, the Swiss counterpart being the IvDV (SR 812.219)
- The Swiss legal basis is the Medical Devices Ordinance (MepV, SR 812.213), modelled substantively on the MDR
- Staggered deadlines in 2021 and 2022 for appointing a CH-REP, depending on risk class and product type
- Economic operator registration with a CHRN, product records in swissdamed, UDI required on labelling and in documentation
What duties do the representative, importer and distributor carry?
The Swiss authorised representative is the foreign manufacturer's legal point of contact in Switzerland: it keeps the technical documentation available, cooperates with Swissmedic, participates in incident reporting and field corrective actions, and is named with address on the labelling or in the accompanying information.
Importer and distributor carry their own duties, which cannot be delegated away. They verify labelling, declaration of conformity and UDI before placing a device on the market, respect storage and transport conditions, keep traceability records and pass complaints to the manufacturer and the representative. Swissmedic sets out these duties in an information sheet for economic operators.
| Role | Core duties | Basis |
|---|---|---|
| Swiss authorised representative (CH-REP) | Written mandate, technical documentation kept available, contact with authorities, participation in incidents and recalls | MepV (SR 812.213), IvDV (SR 812.219) |
| Importer | Verify conformity and labelling, check the CH-REP details, respect storage conditions, keep a complaints register | MepV, Swissmedic information sheet on economic operator duties |
| Distributor and specialist trade | Visual check before passing on, traceability down to the recipient, participation in field corrective actions | MepV, Swissmedic information sheet on economic operator duties |
| Manufacturer outside Switzerland | Appoint a CH-REP, secure conformity assessment, run post-market surveillance | MDR (EU) 2017/745 and MepV |
| All economic operators | Registration with Swissmedic under a CHRN, product records in swissdamed, UDI assignment | MepV, Swissmedic swissdamed requirements |
| All economic operators | Report serious incidents and field safety corrective actions to Swissmedic | MepV, Swissmedic vigilance requirements |
What does this mean commercially, and who are the players?
Commercially, third-country status means dual compliance: two representatives, two registrations, two labelling variants and two regulatory channels for a product that is technically unchanged. For small portfolios the fixed cost per article can exceed the Swiss revenue it defends.
Notified body capacity compounds it. The MDR requires a conformity assessment body for many devices that previously ran through self-certification; the number of bodies and their throughput are limited, which explains waiting times of months and costs in the five to six figure range per product family.
The predictable result was portfolio pruning. Niche articles, paediatric and rare sizes and old legacy devices left the Swiss market because recertification cost more than the contribution margin. Swissmedic can grant exemptions for non-conforming devices where there is a supply interest.
The notable names by segment: Sonova with its Phonak brands in hearing systems, Straumann and Medartis in dental and osteosynthesis, Ypsomed in injection systems, Mathys and Medacta in orthopaedics, Hamilton Medical in ventilation, Alcon in ophthalmology, Roche Diagnostics in in vitro diagnostics, plus a broad supplier field in the Jura arc.
- Determine the product class and rulebook: medical device under the MepV or in vitro diagnostic under the IvDV
- Settle representation: a CH-REP for Switzerland, an EU Authorised Representative for the EU, each on a written mandate
- Complete registration: apply for a CHRN with Swissmedic, record products in swissdamed, assign UDI
- Document the supply chain: allocate importer and distributor duties contractually, test traceability
- Choose the site: pick the cluster by manufacturing technology and available specialists, not by prestige
Frequently asked questions
How many medtech companies are there in Switzerland?
Swiss Medtech reports roughly 1400 companies and several tens of thousands of employees in its industry study. The count covers manufacturers, suppliers, distributors and service providers and is an association estimate. There is no federal sector definition in this exact form, so figures differ by source.
Does a medical device need authorisation from Swissmedic?
No. Devices are not authorised; they undergo conformity assessment, and from certain risk classes upward a designated body must be involved. Swissmedic runs market surveillance, maintains the economic operator registration and can grant exemptions for non-conforming devices.
Who needs a Swiss authorised representative (CH-REP)?
Every manufacturer without a Swiss domicile that places medical devices or in vitro diagnostics on the Swiss market. The CH-REP is appointed under a written mandate, must be named on the labelling or in the accompanying information and serves as the contact point for Swissmedic.
Why did the MRA chapter for medical devices lapse?
Because it had to be updated to the MDR and the EU tied that update to the institutional framework agreement. After the agreement was abandoned, the update never came; since 26 May 2021 Switzerland counts as a third country in device law, with dual representation and registration duties.
Which canton is the largest medtech location?
By employment, Bern, Solothurn, Zurich and Basel-Stadt lead, in an order that shifts with the definition used. Technology matters more than the cantonal ranking: injection systems around Bern, microtechnology in the Jura arc, hearing systems on Lake Zurich, dental and osteosynthesis in Basel.