What is holding you back today.
Switzerland is no longer covered by the EU MRA
Since May 2021, as an EU manufacturer you need a Swiss authorised representative (CH-REP). Without one there is no market access.
A complex set of rules
MedDO, MDR, Swissmedic obligations, swissdamed, EUDAMED reconciliation, DE/FR/IT language versions: a lot to learn for a single requirement.
Operational burden of vigilance
Incidents must be reported to Swissmedic within clear deadlines. Without a Swiss establishment that is hard to meet.
A range that matches your requirements.
The product categories most relevant to your needs.
What you get at Luptek.
Registered and ready
Importer registration CHRN-IM-20010698 and CH-REP registration CHRN-AR-20010699 with Swissmedic, ready to use immediately.
Complete mandate
We take on all obligations under Art. 51 MedDO: registration, market surveillance, corrective actions and communication with the authorities.
Insured cover
Our own product liability cover of CHF 5 million relieves you as manufacturer of the Swiss liability risk.
Personal PRRC function
The person responsible for regulatory compliance on site (Art. 15 MDR / Art. 51 MedDO) is appointed and available.
Distribution optional
The CH-REP mandate on its own or combined with our distribution service. You decide how far the cooperation goes.
Clear terms
Transparent setup fee and annual flat rate per product, with no hidden hourly billing.
Why Luptek is the right partner.
With the lapse of the EU–Switzerland MRA for medical devices in May 2021, every foreign manufacturer needs a Swiss authorised representative (CH-REP) under Art. 51 MedDO. Without a CH-REP there is no market access. Luptek offers a complete, registered and insured mandate here: we handle the Swissmedic registrations, maintain the swissdamed entries, process vigilance reports and are PRRC certified. Optionally we combine the CH-REP mandate with distribution: you deliver to our warehouse and we market to Swiss specialist retailers and clinics. Regulatory representation then becomes a door-opener to the Swiss market rather than a mere formality.
Frequently asked questions.
What does a CH-REP mandate at Luptek cost?
One-off setup fee plus an annual flat rate per product. Exact terms depend on the range and risk class, enquire via the contact form.
Which manufacturers can use this?
All manufacturers outside Switzerland with CE-certified medical devices of class I, IIa, IIb or III. Custom-made devices are handled separately.
How long does registration take?
After the contract is signed, registration typically takes 2 to 4 weeks. Complete UDI lists and EU declarations of conformity from the manufacturer are required.
Can you also handle Swiss distribution?
Yes, optionally. We have an established B2B network of Swiss medical supply stores, clinics and rehab retailers. Distribution is available as an add-on to the CH-REP mandate.
Ready to work together?
Registration in 2 minutes, approval within 24 hours.