Regulation (EU) 2017/745 and Regulation (EU) 2017/746 govern the market for medical devices and in vitro diagnostics across the Union, and since the lapse of the Swiss mutual recognition agreement in 2021 they govern Switzerland only at one remove: a US manufacturer serving both markets appoints an EU authorized representative and a Swiss CH-REP, registers in EUDAMED and with Swissmedic, and runs two clocks that do not tick together. The analyses below cover the dual-track reality, the IVDR's extended transition and its Swiss mirror in the IvDV, mandatory EUDAMED registration, the Bilaterals III protocols that leave the devices chapter undated, and the software questions, from classification to post-market surveillance, that decide where a product sits.
10 insights · latest June 2026
The regulatory landscape is shifting from compliance-as-checkbox to compliance-as-competitive-advantage. Strategic implications for Swiss manufacturers navigating dual-track market access.
Swiss MedTech manufacturers face EU authorized representative requirements under MDR/IVDR. Liability implications extend beyond formality.
The lapsed Mutual Recognition Agreement creates a dual regulatory burden for Swiss manufacturers. Strategies to mitigate the cost and complexity of parallel compliance.
Switzerland has been a third country for medical devices since May 2021, and the Bilaterals III protocols signed in March 2026 leave the MRA devices chapter to an undated Committee decision, so dual authorized representation persists.
Mandatory use of EUDAMED's first four modules began on 28 May 2026, putting actor registration upstream of conformity assessment for US device and IVD makers and setting backfill deadlines for devices already on the EU market.
Regulation (EU) 2024/1860 extends legacy IVD deadlines to 2027, 2028 and 2029, but the relief is conditional on notified-body filings that already fell and a design freeze. Switzerland's IvDV mirrors those dates but requires its own CH-REP and registration.
SaMD classification under EU MDR creates regulatory exposure developers discover post-launch. Marketing claims often inadvertently determine regulatory status.
SaMD clinical evidence under EU MDR requires analytical validation, clinical validation, and real-world evidence (burdens many software developers underestimate).
SaMD post-market surveillance extends beyond incident reporting. Algorithm monitoring, vigilance, and PSUR requirements create ongoing compliance burdens.
AI-enabled medical software reaches high-risk status through the AI Act's Annex I product route rather than Annex III, so obligations attach in 2027 and are assessed as a second layer inside MDR conformity assessment.
Counsel on this topic: MDR / IVDR compliance counsel.
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