US medical device manufacturers carry a serviceable mental map of Europe. FDA clearance sits on one side of the Atlantic and the CE mark on the other, and Switzerland files somewhere inside that second category. It does not belong there. Since 26 May 2021 Switzerland has been a third country for medical device purposes, and a manufacturer shipping into Basel and into Munich runs two conformity chains rather than one. What changed on 2 March 2026 was the burden's expected lifespan. The Switzerland and European Union package, the bulk of it signed that day, carries within it an update to the very agreement whose lapse created the burden, but not one that restores the medical devices chapter. The date on which anything reaches that chapter is not knowable, and the gap between those two facts is where the planning problem lives.
1. What Lapsed in 2021, and What a Restoration Would Restore
The instrument at the center of this is the 1999 agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment, in force since 1 June 2002 and known to practitioners as the MRA. Medical devices occupy Annex 1, Chapter 4 of the MRA.1Agreement of 21 June 1999 on mutual recognition in relation to conformity assessment (SR 0.946.526.81), Annex 1, ch 4. The chapter was drafted against the old device directives, and it was never rebuilt for the regime that replaced them. In the consolidated text of the MRA published by SECO, Chapter 4 still lists Directive 90/385/EEC and Directive 93/42/EEC among the covered Union provisions, and reaches Regulation (EU) 2017/745 only as to its Chapter IV and Annex VII, the parts governing the designation and supervision of notified bodies. The substantive conformity regime of the MDR was never listed as covered legislation; it reached the MRA only through a transitional derogation in point 5 of the chapter's Section V, which let devices complying with the MDR be placed on both markets and had the Parties recognize certificates issued under it.
The consequence arrived on the day the MDR became applicable. The European Commission's notice to stakeholders of 26 May 2021 records that the chapter's trade-facilitating effects for devices falling under the new regulation, "including the mutual recognition of conformity assessment results, the absence of the need for an authorised representative and the alignment of technical regulations", ceased to apply that Wednesday.2European Commission notice to stakeholders on the status of the EU-Switzerland MRA for medical devices, Brussels, 26 May 2021. Two details in that notice deserve more attention than they usually receive. The first is that the Union had, on 30 March 2021, proposed a limited modification of the chapter that would have preserved the validity of existing devices with Swiss certificates until 26 May 2024 at the latest, together with the same transitional validity for certificates issued in the Union, and that this modification "was not agreed ahead of 26 May 2021". A transitional arrangement was available, was tabled, and did not happen. The second is the Commission's framing of why: absent a deal on the institutional framework, "a full update of the MRA cannot be considered, including the medical devices chapter". The devices chapter was never a devices problem.
For a US manufacturer the analytically important passage of the 2021 notice is easy to skim past. It states that, "for existing certificates issued under the MRA by conformity assessment bodies established in the EU", third-country manufacturers "whose authorised representative was previously established in Switzerland, must designate an authorised representative established in the EU". That sentence is only intelligible if, before the lapse, a manufacturer established in neither party could satisfy the Union's representation requirement through a representative established in Switzerland. It could. The chapter spared Swiss and Union manufacturers from appointing representatives in each other's territory, and it also let a manufacturer outside both consolidate the function in one place. That is the structural benefit a US company lost, and the published materials do not promise its return.
What would a restoration restore? The lapsed chapter recognized conformity assessment carried out under directives that no longer exist. Any updated chapter must be built on the MDR and on Regulation (EU) 2017/746, and the Bilaterals III package proceeds through an amending protocol and an institutional protocol rather than a reinstatement of the old text. A manufacturer reasoning by analogy from what the pre-2021 regime delivered is reasoning from an instrument that will not be the one in force.
The chapter whose effects ceased in 2021 and whatever chapter a later Committee decision would put in its place are not the same provision, and no published text says what becomes of the obligations built in the years between them.
2. The Switch Date Belongs to Swiss Domestic Politics
The procedural facts are firm and worth stating with the precision the situation lacks elsewhere. Most of the Switzerland and European Union package, including the amending protocol to the MRA, was signed in Brussels on 2 March 2026, the agreement on Swiss participation in Union programs having been signed earlier, on 10 November 2025. On 13 March 2026 the Federal Council adopted its dispatch to Parliament, published in the Bundesblatt No. 53 of 18 March 2026. The package updates the MRA through an amending protocol and an institutional protocol, neither of which realigns Chapter 4 MRA with the MDR: the amending protocol touches that chapter in one respect only, recording that Switzerland takes part as an observer in the Medical Device Committee and the Medical Device Coordination Group, while integration of Union acts into Annex 1 MRA is left to the Committee established under Art. 10 of the agreement, acting under Art. 5(4) of the institutional protocol. The Federal Council proposed, by decision of 30 April 2025, that the whole package be subject to the optional treaty referendum.3Federal Council dispatch of 13 March 2026 on the Switzerland-EU package, Geschäft 26.023, BBl 2026 615, carried in the Bundesblatt No. 53 of 18 March 2026 by reference only; signature 2 March 2026. The Federal Council's factsheet of 13 March 2026 is blunter than most official Swiss prose about the cause of the impasse: the Union has refused in principle to update the agreement since May 2021 because institutional questions are unresolved, and medical devices are at present the sector concretely affected.4Federal Council, Technische Handelshemmnisse (MRA), Faktenblatt of 13 March 2026.
The same factsheet contains a sentence whose implications repay slow reading. The institutional protocol and the adaptations foreseen in the amending protocol to the MRA require, at present, no change to Swiss law and no accompanying measures. Taken at face value, that means the domestic provisions imposing a Swiss authorized representative on foreign manufacturers are not scheduled for repeal by the package that is supposed to make the representative unnecessary. The published materials do not say whether the treaty displaces those provisions by operation of law, whether an ordinance amendment follows, or whether either happens on the day the package enters into force.
The referendum question leaves the timing even less certain. The Federal Council asked for the optional referendum, which requires only a majority of the people. The state-policy committees of both chambers have instead moved to place the package on a constitutional basis, which would require a majority of the people and of the cantons, and as of publication neither chamber has decided the point in plenary.5Committee media releases of 6 and 22 May 2026 on parliamentary initiative 26.425; both state-policy committees favor a double majority, and neither chamber has decided in plenary. Press estimates place a plenary decision in 2027 and a popular vote in 2028. Those are estimates. No official date exists for the vote, none exists for entry into force, and consequently none exists for the moment the medical devices chapter begins to operate again.
This is an unfamiliar species of regulatory risk for a US in-house lawyer. The reader's instinct, trained on FDA transition policies and on the Federal Register, is to look for the effective date and to work backward from it. Here the effective date depends on a parliamentary calendar, a contested constitutional characterization, a signature-gathering threshold that cannot even be triggered until Parliament has finished, and a popular vote. Parliament and the electorate, who control those steps, are not regulators, are not accountable to manufacturers, and are under no obligation to sequence their work around a device portfolio.
3. Which Commitments Unwind Cheaply, and Which Do Not
Other articles on this site describe the third-country burden itself, and the analysis of Swiss medical device exports without the MRA sets out in detail the parallel compliance work it forces. The question here is narrower and, for a company committing capital in 2026, sharper: of the commitments a manufacturer makes today, which dissolve when the treaty changes and which survive it?
Begin with the mandate. Art. 51(1) MepV permits a manufacturer without a Swiss seat to place devices on the market only if it has mandated a person established in Switzerland, and the mandate must be agreed in writing.6MepV of 1 July 2020 (SR 812.213), Art. 51 on the Swiss authorized representative, Art. 55 on registration, and Art. 25(4) on recognition of EU certificates. Art. 51(3) MepV then does something a US reader should not skim: it provides that the representative's rights, duties, and the scope of the mandate are determined by Art. 11 MDR. Swiss law does not restate the obligations; it incorporates the Union provision by reference. Art. 51(4) MepV extends the technique to exit, providing that a change of representative is determined by Art. 12 MDR. The CH-REP is therefore a Swiss office whose content is written in Brussels, and a manufacturer that negotiated its mandate against Art. 11 MDR as it reads at publication has negotiated against a provision the Commission proposed to revisit in its unadopted medical devices simplification proposal of 16 December 2025. Whether the Swiss reference travels with a future amendment of Art. 11 MDR, and on what date, is not addressed by the ordinance.
The obvious response is that a mandate is a contract, contracts have terms, and a term that expires is a commitment that unwinds itself. That response overlooks the representative's statutory liability. Art. 47d(2) HMG provides that the authorized person is jointly and severally liable with the manufacturer toward the injured party, and Art. 47d(1) HMG requires the manufacturer or that person to hold adequate financial coverage for damage caused by defective medical devices.7HMG (SR 812.21), Art. 47d on financial coverage and the joint and several liability of the authorized person; in force since 26 May 2021. The timing is not incidental. Art. 47d HMG entered into force on 26 May 2021, the same day the chapter's effects ceased. Swiss law fastened a statutory liability onto the CH-REP at the precise moment the CH-REP became unavoidable.
That liability is also thinner than its Union counterpart, which is a difficulty rather than a comfort. Art. 11(5) MDR makes the authorized representative legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer, and it conditions that liability on the manufacturer's non-compliance with Art. 10 MDR.8Regulation (EU) 2017/745 (MDR), Art. 11(1) on designation, Art. 11(3) on mandate tasks, Art. 11(5) on liability, and Art. 12 on change of representative. Art. 47d(2) HMG states the joint and several result and stops. It does not name the basis, the fault standard, the defect requirement, or what happens where goods reach the Swiss market without the representative's knowledge. The two representatives therefore answer under two liability rules, and one of those rules is a single sentence. A treaty that restores mutual recognition of conformity assessment does not obviously say anything about either.
Then consider the artifacts. Art. 55 MepV requires the manufacturer or its representative, and the importer, to register the required particulars with Swissmedic within three months of first placing a device on the market, obliges them to report changes within one week, and has Swissmedic allocate a single Swiss registration number. The representative's name and address appear on labeling, an obligation Art. 16(1) MepV imports by reference to Annex I, Chapter III of the MDR. Neither a registration record nor a printed carton is a contract with a termination clause. Registrations are entries that must be corrected by someone with standing to correct them; labeling changes have artwork lead times, notified-body implications where the label forms part of the technical documentation, and stock already in the field. A change of representative is not a unilateral act either: Art. 12 MDR requires its detailed arrangements to be fixed in an agreement between the manufacturer, the incoming representative, and, where practicable, the outgoing one, and the Medical Device Coordination Group's guidance treats such a tripartite agreement as the norm.9MDCG 2022-16, Guidance on Authorised Representatives Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on in vitro Diagnostic Medical Devices (IVDR), on mandate content and change of representative. The analysis here does not identify a Swissmedic instrument of equivalent scope for the CH-REP mandate, and none of that guidance contemplates the representative's role ending because a treaty entered into force.
No published Swiss or Union instrument says how these things are to be unwound, or when, or at whose cost, and the last time this chapter moved, the transitional arrangement the Union itself had proposed was not agreed.
4. The Asymmetry That Survives Restoration
Switzerland did not sit still after 2021. By an ordinance adopted on 19 May 2021 and in force from 26 May 2021, the Federal Council inserted Art. 25(4) MepV, under which certificates issued by notified bodies established in an EU or EEA state are treated as equivalent to Swiss certificates. The drafting deserves quotation in substance, because it decides more than it appears to. The provision reaches only certificates that are not recognized under an international agreement, and only where it can be credibly shown both that the conformity assessment procedures applied satisfy Swiss requirements and that the issuing body holds a qualification equivalent to the Swiss one.
Read that conditional again. Swiss unilateral recognition is drafted as a fallback for the absence of a treaty. If the medical devices chapter is updated and enters into force, the certificates it covers become recognized under an international agreement, and Art. 25(4) MepV ceases, by its own terms, to be the route by which they are accepted. Recognition would not be withdrawn; it would move. The ordinance does not say what that migration does to a certificate a manufacturer has been relying on under the fallback, or to a Swissmedic file assembled to make the credible showing the fallback demands.
The deeper asymmetry is structural, and it is the one a US manufacturer is most likely to misprice. Art. 11(1) MDR imposes the representation duty on a manufacturer not established in a Member State. Art. 51(1) MepV imposes it on a manufacturer without a seat in Switzerland. A US company is established in neither, and so it is caught by both provisions in their own terms, regardless of the treaty. Restoration of mutual recognition would relieve a Swiss manufacturer of the Union representative and a Union manufacturer of the Swiss one. It would not, on the face of either provision, relieve a manufacturer established outside both. What the 2021 notice suggests the old chapter did deliver to third-country manufacturers was something subtler: the ability to satisfy the Union requirement through a representative established in Switzerland. Whether the updated chapter reproduces that effect, whether it reproduces it for manufacturers rather than only for conformity assessment, and whether a US company's Swiss entity or its Irish one would emerge as the surviving representative, are questions the published protocols answer only with a default rule. The general provisions that the amending protocol inserts into Annex 1 let an obligation that a listed Union act places on an operator established in the Union be met by one established in Switzerland, and the reverse, where that is necessary for implementing the agreement and unless a technical adaptation to the relevant chapter provides otherwise. The chapter does not yet list the MDR's representative provisions, the adaptation that would list them is the Committee's to write, and a rule that permits either entity does not say which one survives.
The timing makes this concrete. The extended transition for legacy devices under Art. 120(3a) MDR, as amended in 2023, expires on 31 December 2027 for class III devices and class IIb implantables outside the enumerated exceptions, and on 31 December 2028 for other class IIb devices, class IIa devices, and class I devices placed on the market sterile or with a measuring function.10Regulation (EU) 2023/607 amending the MDR and IVDR transitional provisions; deadlines of 31 December 2027 and 31 December 2028. Those deadlines fall inside the window in which the package is projected to be voted on and before any plausible entry into force. A manufacturer's certificate transition work and the treaty's timetable are out of phase, and the transition work will be finished, and paid for, on the assumption that the rules in force hold.
Liability is diverging on the same schedule. The revised Union product liability regime must be transposed by 9 December 2026, and where the manufacturer is established outside the Union it places the authorized representative among the economic operators who may be held liable.11Directive (EU) 2024/2853 on liability for defective products, to be transposed by 9 December 2026; Swiss product liability rests on the PrHG. Swiss product liability rests on the PrHG, which the Union instrument does not touch. So in the same period during which a treaty is supposed to dismantle the trade barrier that requires two representatives, the liability attaching to each of them is moving apart. Regulatory affairs may be tracking the treaty. Legal may be tracking the liability directive. The representative mandate may memorialize neither.
5. Strategic Considerations for US Medical Device Manufacturers
No public source can tell a manufacturer whether to price a CH-REP mandate signed in 2026 as an indefinite obligation or a temporary one, because its duration depends on a parliamentary calendar, a contested constitutional characterization, and a popular vote. A manufacturer that prices it as indefinite overpays for a function that may become redundant; one that prices it as temporary discovers, if the package fails at the ballot box, that it negotiated a long-term regulatory relationship on short-term terms. The choice cannot be deferred, because the mandate must be agreed in writing before the first device is placed on the market.
Beneath that sits a harder question about what the statute has already fastened in place. Art. 47d(2) HMG attaches liability to the authorized person by operation of Swiss law, not by operation of the mandate. Swiss transitional law will decide whether liabilities that have already attached in respect of devices placed on the Swiss market survive the entry into force of a treaty that says nothing about them; no published instrument addresses the point, and the answer is unlikely to be the same for a device supplied in 2024 and one supplied the week before the switch. A representative contemplating the end of its mandate will read that question differently from the manufacturer contemplating the end of its payments.
Then there is the group structure. If a company built or acquired a Swiss entity to hold the CH-REP function, restoration may make that entity redundant, or may make it the only representative the company needs. The two outcomes point in opposite directions on every decision the company must take in the interim: whether to capitalize the entity, whether to staff it with the regulatory competence a surviving representative would require, and whether to house the technical documentation there. Instead of housing it there, the manufacturer and the representative may agree by contract, as Art. 51(3bis) MepV permits, that the manufacturer supplies the documentation to Swissmedic on request in place of the representative holding a copy, with the representative ensuring that delivery follows within seven days. That arrangement is cheap while the entity is a formality and expensive to reverse if the entity becomes the counterparty on which Union market access also depends.
Finally, and least comfortably, there is the question of what has been documented. The period since May 2021 has been one of continuous accommodation: mandates signed under time pressure, labeling revised, registrations filed, allocations of liability agreed in correspondence rather than in amendments. The decisions themselves were usually made. Whether they were documented, escalated, and revisited as the treaty position moved is less certain, and that is what surfaces when a regulator, a plaintiff, or a counterparty asks who was responsible for what, on which date, under which instrument. A treaty entering into force will only fix the date on which someone finally asks.