Practice Areas
Distribution & Market Access
Getting a device to market in Europe means selecting channel partners who can carry regulatory obligations, not just commercial ones. MDR shifted responsibility to importers and distributors in ways that make legacy distribution agreements structurally incomplete. Every market access contract must now address who holds which compliance obligations, and what happens when those obligations are breached.
- Distribution agreements with MDR/IVDR responsibility allocation
- Authorized representative appointments
- Importer and reseller arrangements
- Territory and channel conflict structures
Supply Chain & Manufacturing
Device supply chains generate regulatory interfaces at every handover point. OEM/ODM arrangements, component supply, and contract manufacturing all require quality system integration and clear allocation of design control, complaint handling, and post-market obligations. The contract must mirror the quality system, not the other way around.
- OEM/ODM agreements
- Supply and quality agreements
- Contract manufacturing with design transfer
- Subcontractor and component supply arrangements
Regulatory & Clinical Contracts
Clinical investigations, post-market clinical follow-up, and regulatory submission work all generate contractual obligations that track the device lifecycle. Each agreement (with notified bodies, clinical sites, or CROs) must support both the regulatory submission strategy and the broader commercial development timeline.
- Clinical investigation agreements
- PMCF study contracts
- Notified body and testing house arrangements
- Technology licensing and co-development
Swiss Authorized Representative (CH-REP)
With the EU–Switzerland mutual recognition agreement no longer covering medical devices (its device chapter was not updated after the MDR, so mutual recognition no longer applies), Switzerland is a third country for market access. A manufacturer domiciled outside Switzerland must appoint a Swiss authorized representative (CH-REP) to place devices on the Swiss market, the counterpart to the EU authorized representative under the MDR. Under the MepV (and, for in-vitro diagnostics, the IvDV), the CH-REP holds the technical documentation, registers the manufacturer and devices with Swissmedic, and serves as the contact point for the authority and for incident reporting.
- CH-REP mandate under the MepV / IvDV
- Technical-documentation custody and Swissmedic registration
- Contact point for Swissmedic, vigilance and field-safety correspondence
- Coordination with the EU authorized representative (mirror role)
Getting Started
Most engagements begin with a scoping call to define the matter, regulatory context, and timeline. From there, the engagement is structured (hourly, project-based, or retainer) to fit the scope and existing internal processes.
For device companies managing distribution networks, supply chains, and regulatory obligations across multiple markets, fractional counsel arrangements provide continuity without the overhead of additional headcount.
MedTech matters are handled through these engagement formats: