Motion 20.3211 and the FDA pathway: a possible window for non-CE manufacturers

This article is the 50th instalment of Volume 5, Post-market Compliance and Regulatory Developments, of the 50-part series on medical device registration in Switzerland. Together with the remaining nine articles of this volume it forms the complete deliverable on this topic. The publication timestamp, article number, title and unique URL are set out in the table below.

1. Key takeaways

Motion 20.3211 was submitted in November 2022, and the Federal Council established its position on 30 April 2025: for devices already authorised by the US FDA, private bodies are to verify the Swiss deviations from FDA requirements under a simplified conformity assessment procedure; the work is being further developed under the lead of the Federal Department of Home Affairs, and no date of application exists yet. This is a pathway taking shape, not a pathway already open. For manufacturers holding FDA authorisations, the practical message is twofold. First, the direction of travel is favourable: Switzerland is explicitly designing a reduced route for FDA-cleared products. Second, nothing about that route can be relied on today, because its criteria, its verifying bodies and its start date are all still unsettled, and compliance obligations under the current rules continue to accrue in the meantime.

2. Legal basis

3. Expert insights

1. The position is set but the details are not, and the distance between the two is the risk zone. The position established by the Federal Council on 30 April 2025 contains three elements: the target group is devices already authorised by the US FDA; the verifying bodies are private; and what is verified are the Swiss deviations from FDA requirements, using a simplified conformity assessment procedure. The judgement is that these three elements sketch an institutional framework, but the qualifications of the verifying bodies, the verification checklists and the fee levels all lack a date of application. The counterpoint is that a company which positions itself early in anticipation of these details carries the risk that the rules land differently from what it assumed, and it must be willing to absorb that risk as part of its market-entry strategy.

2. The simplified procedure verifies deviations, but it is not an exemption from Swiss substantive requirements. MedDO Art. 6 para. 1 and 2 require devices to comply with the ordinance and to satisfy the general safety and performance requirements, the GSPR, of Annex I to the EU MDR before being placed on the market; classification follows Art. 15 and Annex VIII to the EU MDR, and conformity assessment follows Art. 23 in combination with EU MDR Art. 52. The judgement is that even if the FDA pathway materialises, what would be verified are the Swiss deviations from FDA requirements, typically the trilingual product information under Art. 16 para. 2 and the CH-REP designation under Art. 51 para. 1. Reading the simplified procedure as a blanket exemption produces a placement with direct compliance gaps, because the Swiss-specific duties remain in force unless amended.

3. Current obligations run in parallel; there is no option of waiting for the pathway to open. The device registration duty applies from 1 July 2026 under MedDO Art. 108, registration fees are charged under Annex 2 of the fee ordinance, and the first billing time point is 31 December 2026; devices subject to serious incident, FSCA or trend reporting must be registered without transition from 1 July 2026. The trade-off is that Motion 20.3211 is intended to lower entry costs for non-CE manufacturers, but its progress is not coupled to the current timetable in any way. As a practical estimate, manufacturers holding FDA authorisations should complete CH-REP designation and registration under the current rules, while tracking the further development of the motion as a recurring observation item.

4. Practical recommendations

1. For devices already authorised by the FDA, complete conformity assessment, CH-REP designation and swissdamed registration under the current rules first; do not delay compliance investment because of the motion’s progress.
2. Pre-build a deviation list (practical estimate: trilingual product information, CH-REP designation, UDI and the allocation of vigilance duties) so it can connect directly to the verification once the details are settled.
3. Track the further development of Motion 20.3211 as a quarterly observation item, following the procedures and body-qualification requirements published by the Federal Department of Home Affairs.
4. Keep any expected entry-into-force date for this pathway out of the business plan; no date of application exists, so any date would be pure speculation.
5. Keep the CH-REP mandate relationship continuous, so that when the pathway lands the company can place on the market immediately without a gap in representation.

5. Verification checklist

• □ It is recorded that Motion 20.3211 was submitted in November 2022 and that the Federal Council established its position on 30 April 2025.
• □ It is confirmed that the pathway has no date of application yet and is being developed under the lead of the Federal Department of Home Affairs.
• □ Current compliance actions (CH-REP, CHRN, swissdamed registration) have not been postponed because of the motion’s progress.
• □ The Swiss deviation list has been pre-built and can be updated at any time.
• □ The scope of the FDA authorisation has been checked for consistency with the intended purpose to be declared in Switzerland.
• □ A responsible owner for the quarterly observation and review of the motion has been designated.

Legal information verified as of 29 October 2026.

GRZAN supports manufacturers entering or operating in the Swiss market with post-market compliance services, covering vigilance reporting, field safety corrective actions and Swissmedic inspection readiness. Our team keeps FDA-authorised manufacturers compliant under the current Swiss rules, maintains the deviation list for the Motion 20.3211 pathway and monitors its development with the Federal Department of Home Affairs. For support with your Swiss post-market obligations, contact info@grzanglobal.com.