What matters when choosing
Whether surgical instruments, theatre consumables, suction equipment, wound care or products for urology and endoscopy: for hospitals, clinics and medical practices, a broad range alone is not enough. What counts is whether a product fits the actual application, whether it is reliably available day to day, and whether competent support is at hand when questions arise.
Good selection therefore starts not in the catalogue but with a clear description of what you need. The following four levels help you compare suppliers and products in a structured way.
- Application: does the product suit the specialty, procedure, patient group and existing equipment?
- Compliance: may the product lawfully be placed on the Swiss market, and is the documentation complete?
- Supply: is delivery secured during peaks, holiday periods or global shortages?
- Service: are training, support with reprocessing and sterilisation, maintenance and fast answers to problems available?
The regulatory framework in Switzerland
In Switzerland, medical devices fall under the Therapeutic Products Act and the Medical Devices Ordinance (MedDO, German MepV); in vitro diagnostics are covered by the IvDO. The MedDO was largely aligned with the EU Medical Device Regulation (MDR) in 2021. The supervisory authority is Swissmedic.
Because the mutual recognition agreement with the EU was not updated for medical devices, Switzerland has since been treated as a third country by the EU. This has practical consequences for buyers: manufacturers based abroad need an authorised representative in Switzerland (CH-REP) for the Swiss market, and importers have their own verification duties. CE-marked devices can still be placed on the market as long as these duties are met.
Healthcare institutions have obligations too. These include proper maintenance of devices, reprocessing according to the state of the art and reporting serious incidents to Swissmedic. Hospitals must also designate a vigilance contact person. Depending on ownership and contract value, public hospitals are additionally subject to public procurement law.
Check the current status
The rules are evolving. Parliament has instructed the Federal Council to also admit devices approved under non-European regulatory systems such as that of the USA; as of autumn 2026, implementation was not complete in every respect. Do not rely on older guidance notes: check current requirements with Swissmedic and consult a regulatory affairs specialist if in doubt.
Criteria for comparing suppliers
| Criterion | What to check | Why it matters |
|---|---|---|
| Regulatory documents | Declaration of conformity, labelling, CH-REP and importer details, instructions for use in a national language | Incomplete documentation invites objections and liability risks |
| Quality management | Certifications such as ISO 13485, clear processes for recalls and complaints | Shows whether the supplier handles errors in a structured way |
| Supply reliability | Stock held in Switzerland, lead times, shortage arrangements, substitute items | Missing items disrupt theatre schedules and practice routines |
| Compatibility | Fit with existing equipment, instrument trays, reprocessing processes and in-house standards | Incompatible products create extra work and error risks |
| Service and training | Team onboarding, named contact, support with reprocessing and sterilisation | Ensures correct use across the whole life cycle |
Certificates do not replace testing in practice, but they provide a verifiable framework, especially when several suppliers are in contention. Ask whether a certificate covers the whole company or only one site, and how long it remains valid.
Total cost, not unit price
Many purchases are judged on the purchase price. Yet the real effort often arises when a process is interrupted: an item is missing, the substitute does not fit the existing system, or a question about reprocessing goes unanswered for days. Rescheduling, postponements and extra work for the team then quickly cost more than was saved on the unit price.
A realistic example: a practice switches to cheaper single-use instruments to cut costs. After a few weeks it turns out that handling is different, the team needs additional training and some sizes are not reliably available. The saving per item is eaten up by lost time and emergency orders.
The cheapest item is not cheap if it interrupts a process.
When evaluating offers, therefore, consider storage costs, expiry, training effort, reprocessing, disposal and the cost of a shortfall alongside the price.
Handling a supplier change properly
When switching, the critical point is rarely the product itself but the transition. A structured approach reduces the risk of gaps in daily operations.
- Define needs with the clinical department: applications, quantities, variants and minimum stock.
- Obtain and check regulatory documents and quality evidence before deciding.
- Have samples tested in daily use, ideally by the people who will later use the product.
- Agree transition periods, remaining stock, substitute items and contacts in writing.
- Train the team, adapt reprocessing instructions and update internal documentation.
- Review after a few months: supply reliability, complaints and team feedback.
Bring purchasing, clinical staff and reprocessing together
Many problems arise because purchasing decides without involving reprocessing or the users. A short joint discussion before the decision saves a lot of corrective work later.
Frequently asked questions
Can CE-marked devices be used in Switzerland?
What role does ISO 13485 play?
What must a practice do after an incident?
Is it worth bundling several specialties with one supplier?
How do you recognise a reliable service partner?
When choosing medical devices, do not reduce the decision to the item itself. What matters is whether compliance, supply and service hold up under pressure.