Does a manufacturer outside Switzerland need a Swiss authorized representative?

Yes. A manufacturer whose seat is not in Switzerland may place its devices on the Swiss market only if it has given a written mandate to a person domiciled in Switzerland (Art. 51 MepV; Art. 44 IvDV for in-vitro diagnostics). The representative keeps a copy of the technical documentation available for Swissmedic or, where the mandate so provides, ensures that the manufacturer delivers it to Swissmedic within seven days of a request (Art. 51 Abs. 3 and 3bis MepV; Art. 44 Abs. 3 and 4 IvDV). It registers the manufacturer and its devices with Swissmedic, bears the responsibility for reporting serious incidents in Switzerland and field-safety corrective actions taken there (Art. 66 Abs. 2bis MepV; Art. 59 Abs. 3 IvDV) and serves as the contact point for the authority. GAWEL Legal structures and reviews these mandates; it does not act as the representative.

Does Switzerland accept an EU authorized representative?

No. Since the mutual recognition agreement stopped covering medical devices, Switzerland is a third country for market access, so the EU and the Swiss role are separate appointments held by separate persons. A manufacturer established outside the EU needs the EU authorized representative (Art. 11(1) MDR; Art. 11(1) IVDR for in-vitro diagnostics), and one whose seat is not in Switzerland needs the Swiss authorized representative (Art. 51 Abs. 1 MepV; Art. 44 Abs. 1 IvDV for in-vitro diagnostics): a US manufacturer selling into both markets needs both, a Swiss manufacturer only the EU one and an EU manufacturer only the Swiss one. Where both are needed, the two mandates have to be coordinated so that vigilance reporting, field-safety corrective actions and custody of the technical documentation do not fall between them.

What did the MDR change in distribution and importer agreements?

The MDR moved regulatory responsibility onto importers and distributors, which leaves legacy distribution agreements structurally incomplete: they allocate commercial risk but not the compliance obligations the regulation now places on the channel. Every market-access contract has to state who holds which obligation, how the parties exchange the information each of them needs to discharge it, and what follows when one of them does not.

What does a GMP / GDP quality agreement have to settle?

A responsibility matrix with exactly one accountable party for each activity, a change-control clause, and the Swiss positions that cannot be delegated checked against the arrangement as drafted. The commercial supply agreement is scoped separately, because a quality agreement that also carries price and volume terms tends to be negotiated by the people who do not own the quality system. GAWEL Legal publishes a fixed fee of CHF 4,500 for this deliverable.

MedTech and diagnostics: MDR, IVDR, MepV

Legal work in this sector

GAWEL advises device and IVD companies on distribution, supply-chain, licensing and market-access matters under the MDR, the IVDR and the Swiss MepV and IvDV. Retained counsel is quoted before engagement; CH-REP mandate structuring is a fixed fee from CHF 6,500, and the GMP / GDP responsibility-allocation agreement a published fixed fee of CHF 4,500.

Distribution & Market Access

Device distribution agreements need to cover the regulatory duties of importers and distributors as well as their commercial roles. Older agreements may not reflect the responsibilities introduced by the MDR. The contract must allocate those duties and address the consequences of a breach.

Distribution agreements with MDR/IVDR responsibility allocation
Authorized representative appointments
Importer and reseller arrangements
Territory and channel conflict structures

Supply Chain & Manufacturing

OEM/ODM arrangements, component supply and contract manufacturing require coordination between quality systems. The agreements need to allocate design control, complaint handling and post-market responsibilities, and reflect how the quality systems operate.

OEM/ODM agreements
Supply and quality agreements
Contract manufacturing with design transfer
Subcontractor and component supply arrangements

Regulatory & Clinical Contracts

Agreements with notified bodies, clinical sites and CROs support clinical investigations, post-market clinical follow-up and regulatory submissions. Their terms need to reflect the conformity-assessment procedure and the planned commercial rollout.

Clinical investigation agreements
PMCF study contracts
Notified body and testing house arrangements
Technology licensing and co-development

Swiss Authorized Representative (CH-REP)

With the mutual recognition agreement no longer covering medical devices, Switzerland is a third country for market access: a manufacturer domiciled outside Switzerland must appoint a Swiss authorized representative (CH-REP) under the MepV (for in-vitro diagnostics, the IvDV). The CH-REP keeps a copy of the technical documentation available for Swissmedic (or, where the mandate so provides, ensures that the manufacturer delivers it to Swissmedic within seven days of a request), registers the manufacturer and devices with Swissmedic, bears the responsibility for reporting serious incidents and field-safety corrective actions in Switzerland, and serves as the authority contact point, obligations every mandate and distribution agreement must reflect.

CH-REP mandate under the MepV / IvDV
Technical-documentation custody and Swissmedic registration
Responsibility for vigilance and field-safety reporting to Swissmedic, and contact point for the authority
Coordination with the EU authorized representative (mirror role)

Defined assignments

The following standard assignments have published fixed fees. Timing is agreed individually in the written fee proposal. If priority handling is expressly agreed, a 50 percent uplift applies. Read about fee arrangements and scope.

Quality Agreement (GMP / GDP)

The GMP / GDP responsibility-allocation agreement for device supply chains, with a complete responsibility matrix and the non-delegable Swiss positions checked. Fixed fee CHF 4,500; multi-site or combination products from CHF 6,000.

Responsibility matrix with one accountable party per activity
Change-control clause; the commercial supply agreement is scoped separately
Legal review and approval of the final document

Commercial Contract Review & Markup

Review and proposed amendments to supplier, SaaS or platform agreements, using standard negotiating positions and explaining each change. Fixed fee CHF 4,500 to 5,500; a review-only issue memo is CHF 2,500.

One full markup pass with per-clause rationale
Up to two negotiation turns included
A short note explaining what was done and why

Working together

The initial discussion covers the work, regulatory context and timing. Scope and fees are agreed before engagement: fixed, capped or phased fees, or a retainer or subscription. Hourly rates apply to work beyond the agreed scope.

For device companies managing distribution networks, supply chains, and regulatory obligations across multiple markets, fractional counsel arrangements provide ongoing legal support on a part-time basis.

To establish which rules apply, the regulatory posture audit reviews the laws relevant to one device or IVD, assesses its compliance position and identifies the work needed to address each gap.

For cybersecurity and product-security questions, the cyber readiness assessment examines whether the Cyber Resilience Act reaches the device at all, what the Medizinprodukteverordnung and the Medical Device Regulation require of its software instead (for an in-vitro diagnostic, the Verordnung über In-vitro-Diagnostika and the In Vitro Diagnostic Regulation), and where the device maker sits under NIS2.

For an AI feature in a device already assessed by a notified body, the medical-AI readiness assessment reviews the additional Artificial Intelligence Act requirements against the existing technical documentation and confirms their assessment within the existing conformity procedure.

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Fractional counsel Fees

Common questions

Does a manufacturer outside Switzerland need a Swiss authorized representative?: Yes. A manufacturer whose seat is not in Switzerland may place its devices on the Swiss market only if it has given a written mandate to a person domiciled in Switzerland (Art. 51 MepV; Art. 44 IvDV for in-vitro diagnostics). The representative keeps a copy of the technical documentation available for Swissmedic or, where the mandate so provides, ensures that the manufacturer delivers it to Swissmedic within seven days of a request (Art. 51 Abs. 3 and 3bis MepV; Art. 44 Abs. 3 and 4 IvDV). It registers the manufacturer and its devices with Swissmedic, bears the responsibility for reporting serious incidents in Switzerland and field-safety corrective actions taken there (Art. 66 Abs. 2bis MepV; Art. 59 Abs. 3 IvDV) and serves as the contact point for the authority. GAWEL Legal structures and reviews these mandates; it does not act as the representative.
Does Switzerland accept an EU authorized representative?: No. Since the mutual recognition agreement stopped covering medical devices, Switzerland is a third country for market access, so the EU and the Swiss role are separate appointments held by separate persons. A manufacturer established outside the EU needs the EU authorized representative (Art. 11(1) MDR; Art. 11(1) IVDR for in-vitro diagnostics), and one whose seat is not in Switzerland needs the Swiss authorized representative (Art. 51 Abs. 1 MepV; Art. 44 Abs. 1 IvDV for in-vitro diagnostics): a US manufacturer selling into both markets needs both, a Swiss manufacturer only the EU one and an EU manufacturer only the Swiss one. Where both are needed, the two mandates have to be coordinated so that vigilance reporting, field-safety corrective actions and custody of the technical documentation do not fall between them.
What did the MDR change in distribution and importer agreements?: The MDR moved regulatory responsibility onto importers and distributors, which leaves legacy distribution agreements structurally incomplete: they allocate commercial risk but not the compliance obligations the regulation now places on the channel. Every market-access contract has to state who holds which obligation, how the parties exchange the information each of them needs to discharge it, and what follows when one of them does not.
What does a GMP / GDP quality agreement have to settle?: A responsibility matrix with exactly one accountable party for each activity, a change-control clause, and the Swiss positions that cannot be delegated checked against the arrangement as drafted. The commercial supply agreement is scoped separately, because a quality agreement that also carries price and volume terms tends to be negotiated by the people who do not own the quality system. GAWEL Legal publishes a fixed fee of CHF 4,500 for this deliverable.

MedTech and diagnostics