A US maker of in vitro diagnostics that watched the European Union extend its transition deadlines in 2024 could be forgiven for filing the news under relief. The headline was accommodating: legacy tests may stay on the European market for several more years, to the end of 2027 where they carry a certificate issued under the old Directive and, where they were self-certified under it, on a staged calendar that runs to the end of 2029 for the lowest classes that qualify. The In Vitro Diagnostic Regulation had proved undeliverable on its original schedule because too few notified bodies existed to certify the volume of products the new law captured, and the legislature extended the deadlines rather than let supply fail.1Regulation (EU) 2017/746 (IVDR) [2017] OJ L117/176, Art. 110 (transitional provisions, as amended). The trouble with reading the extension as a reprieve is that the reprieve is conditional, its qualifying steps run on an earlier calendar of their own, and it has no legal effect in Switzerland, which a US company tends to treat as an appendix to the European market and which is, in law, a separate country with its own Ordinance.2Verordnung über In-vitro-Diagnostika (IvDV) vom 4. Mai 2022, SR 812.219.
1. Two Regulators, One Device: Switzerland Is a Separate Market
The reflex that treats Switzerland as part of the European regulatory space is understandable and, for in vitro diagnostics, wrong. The country is not a member of the European Union and not part of the European Economic Area. It runs its own conformity regime for in vitro diagnostics through the IvDV, which applied from 26 May 2022 in step with the IVDR and which mirrors the European regime closely enough that the two are often described as equivalent.2 Equivalence in substance is not the same as recognition in law. The bilateral Mutual Recognition Agreement between Switzerland and the European Union contains a chapter on medical devices whose covered legislation is still the repealed Directives. The 2017 decision that last amended that chapter brought in only the notified-body provisions of the Medical Device Regulation and the IVDR, cooperation and database access under them, and a transitional derogation, so the mutual recognition of conformity assessment that once smoothed device trade across the border does not extend to products regulated under the new regulations.3Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (MRA) [2002] OJ L114/369, Annex 1, Chapter 4, as last amended by Decision No 2/2017; each side treats the other as a third country for these products.
For in vitro diagnostics, Switzerland and the European Union treat each other as third countries. A CE marking opens the European market and a US manufacturer still has to build a second, self-standing compliance position to sell the same test in Switzerland.
The practical consequence lands squarely on the non-European manufacturer. From the Swiss perspective, a company established in the United States is a foreign manufacturer whether it approaches the market directly or through a European group entity, and the IvDV requires it to act through a Swiss authorized representative established in Switzerland, the CH-REP, before its devices may be placed on the Swiss market.2 A European authorized representative does not fill that role, because the mandate that the IVDR gives an EU representative has effect for the European market rather than the Swiss one. The same logic applies to the importer: a Swiss importer, distinct from the European one, has to be identified and has its own verification duties. The upshot is that a single diagnostic reaches two markets through two parallel chains of economic operators, and the design of that structure, rather than the science of the assay, is where the compliance cost sits.
This separation is not a transitional quirk that will resolve when the deadlines pass. It is the steady state until and unless the Mutual Recognition Agreement is renegotiated to cover the new regulations, which is bound up in the wider and unsettled relationship between Bern and Brussels. A US manufacturer that planned its European entry on the assumption that Switzerland travels with the CE marking will find that assumption fails at the border, and it will usually find out when a Swiss distributor asks for a CH-REP mandate the company has not put in place.
2. The Extended Transition Is Conditional Relief, Not a Holiday
Regulation (EU) 2024/1860 rewrote the IVDR's transitional article to give legacy devices a longer runway, staggered by risk class.4Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices [2024] OJ L 2024/1860. The staggered calendar reaches only those devices whose conformity assessment under the old In Vitro Diagnostic Directive did not involve a notified body, for which a declaration of conformity was drawn up before 26 May 2022, and whose assessment under the Regulation does require one: those may be placed on the market or put into service until 31 December 2027 for the highest-risk class D, until 31 December 2028 for class C, and until 31 December 2029 for class B and for sterile class A devices.5Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) [1998] OJ L331/1, the regime the IVDR replaced; legacy devices are those lawfully placed on the market under it. A device that instead carries a notified-body certificate issued under that Directive runs to a single date, 31 December 2027, whatever its class. Within the self-certified group the staggering tracks the notified-body bottleneck: the riskiest devices, which most need scrutiny, get the least additional time.
In the transitional article, the condition matters more than the year. The extended period is available only where the device continues to comply with the old Directive, where there is no significant change in the design and intended purpose, and where it presents no unacceptable risk to the health or safety of patients, users or other persons or to other aspects of the protection of public health.1 A manufacturer that changes the assay, adds an intended use, or alters the design in a way the Regulation treats as significant loses the benefit and drops into the full IVDR regime for that device immediately. The reprieve therefore behaves as a freeze: it keeps an existing product on the market on condition that it stays the product it already was. For a US developer whose commercial instinct is to iterate, extend claims, and improve the assay, the condition is a live constraint on the roadmap rather than a footnote.
Three further conditions run on a calendar of their own, and this is the part US manufacturers most often overlook. The extension is contingent on the manufacturer having put a quality management system in place by 26 May 2025, on having lodged a formal application with a notified body for IVDR conformity assessment by 26 May 2025 for devices covered by a certificate issued under the old Directive and for class D devices, by 26 May 2026 for class C and by 26 May 2027 for class B and sterile class A, and on the notified body and the manufacturer having signed a written agreement by 26 September of each of those years.6Art. 110(3c) IVDR (n 1), as amended by Regulation (EU) 2024/1860 (n 4); see also European Commission, 'Extension of the IVDR Transitional Periods' (Q&A, July 2024). The 2025 dates already sit in the past, and the rest fall inside the extension itself. A manufacturer that assumed the extension was automatic, and did not file with a notified body or conclude the written agreement in time, does not hold the extended period at all for the affected devices, whatever the 2027 to 2029 end dates might suggest. The generous-looking outer deadline is the visible half of a mechanism whose qualifying steps close quietly and early.
3. The Swiss Ordinance Mirrors the Dates, Not Every Duty
Switzerland moved to keep step. An amendment to the IvDV, in force on 1 January 2025, extended the validity of certificates issued under the old law and adopted the same 2027, 2028 and 2029 end dates for legacy in vitro diagnostics, so that a device does not fall off the Swiss market on a different calendar from the European one.7Änderung der IvDV (n 2) vom 20. November 2024, AS 2024 741, in force 1 January 2025, aligning the Swiss legacy-device end dates with the extended IVDR periods; the 1 July 2026 registration duties come from a separate ordinance of the same date, AS 2024 742. The Ordinance also postponed, to 31 December 2030, the point from which a health institution making and using a device in-house must justify in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance, by an equivalent device available on the market, again in parallel with the European treatment of the same requirement.7 For the outer dates, alignment is close to exact, and a manufacturer can plan the two markets against one wall calendar.
Alignment on dates is not alignment on every obligation, and the divergences are where a US manufacturer running a single European playbook gets caught. Switzerland did not adopt the new European duty, introduced by Regulation (EU) 2024/1860, requiring a manufacturer that anticipates an interruption or discontinuation of supply to give advance notice where it is reasonably foreseeable that the interruption could cause serious harm, or a risk of serious harm, to patients or public health.7 A company that builds its supply-interruption notification process to the European template will hold a process the Swiss Ordinance does not ask for, which is a smaller problem than the reverse but a sign that the two texts are not interchangeable clause for clause. The labeling rules diverge as well: the Swiss regime carries its own requirements for the CH-REP's identity on the device, and it allows the representative's particulars to sit on a document accompanying the device rather than on the label, but only where the device is not intended for self-testing and is not placed on the market under the transitional provisions, a Swiss-specific accommodation with no European twin.7
The two regimes share end dates and diverge on duties. Treating the Swiss Ordinance as a copy of the IVDR is safe for the deadline on the wall and unsafe for the obligations underneath it.
Registration shows most clearly that the two systems are separate even where they look alike. On the European side, use of the EUDAMED database becomes mandatory from 28 May 2026, so that actor, device and certificate registration will then run through the European system rather than through the national channels that the old Directive's registration provisions keep alive until that date.8Commission Decision (EU) 2025/2371 of 26 November 2025 [2025] OJ L 2025/2371, confirming the functionality of four EUDAMED electronic systems; the related obligations apply six months later, from 28 May 2026. Switzerland operates its own database, swissdamed, and its own registration and unique-device-identification obligations, with the Swiss device-registration duty taking effect from 1 July 2026, shortly after the European system goes live.7 A device therefore has to be registered twice, in two systems, against two nearly-but-not-identically timed obligations, and the identifiers and actor roles that each system expects do not populate each other.
4. The CH-REP and Registration Duties Are Already Live
For the Swiss market, the obligations already in force are more pressing than the 2027 to 2029 end dates, and a US manufacturer selling through a Swiss distributor may not have addressed them. Chief among them is the CH-REP. The IvDV requires a manufacturer established outside Switzerland to designate a single Swiss authorized representative under a written mandate before its devices are placed on the Swiss market, and it assigns that representative concrete duties: verifying the declaration of conformity and technical documentation, keeping them available to Swissmedic, cooperating on corrective actions, and receiving vigilance correspondence.2 The transitional deadlines by which a CH-REP had to be in place were themselves staggered by risk class and ran between the end of 2022 and the middle of 2023, but they were open only to a manufacturer established in an EU or EEA state or one that had already mandated a person established there; any other manufacturer has needed a CH-REP since the Ordinance applied on 26 May 2022.2 The point for a US maker in 2026 is blunt: the grace period is over, and a device on the Swiss shelf without a valid CH-REP mandate is not in a transitional gray zone but out of compliance.
The representative's identity is not an internal arrangement. The CH-REP's name and address have to be traceable to the device, on the label or on an accompanying document depending on the type of device, so that a Swiss market-surveillance reviewer and a Swiss user can identify the party answerable within the country.2 This mirrors the rule for medical devices under the parallel MepV,9Medizinprodukteverordnung (MepV) vom 1. Juli 2020, SR 812.213, in force from 26 May 2021. where the same representative structure applies, and it is the same operational discipline that the authorized-representative mandate a Swiss manufacturer has to put in place for the European market demands: the mandate is a living relationship with allocated liability, not a nameplate.
Registration adds a deadline of its own. Economic operators, including the manufacturer through its representative and the Swiss importer, have to register with Swissmedic and obtain a Swiss single registration number, the CHRN, within three months of first placing a device on the Swiss market. That three-month window closes on 1 July 2026, the date from which the registration has to be completed before the first placing and the Swiss device-registration and unique-device-identification duties in swissdamed also apply.7 Because these obligations are keyed to the act of placing a device on the market, not to the legacy end dates, the registration duty already applies to any product on sale in Switzerland, and the swissdamed duties apply from 1 July 2026. A US manufacturer whose Swiss route to market is a distributor arrangement it has not examined at operator-role level is often carrying an unregistered position it does not know it holds.
5. Strategic Considerations for US Makers of In Vitro Diagnostics
The headline deadlines leave four questions unanswered. The first is whether the extension is actually held. For each legacy device intended for the European market, did the manufacturer put a quality management system in place by 26 May 2025 and lodge a notified-body application and conclude the written agreement within the windows the amended transitional article sets for that device's route and risk class, and can that be evidenced? Where the answer is no, the device does not enjoy the extended period whatever its class, and the commercial plan that assumed a 2027 to 2029 horizon rests on a benefit the company never secured.
The second is the freeze. Because the extension is conditioned on the absence of significant change to the design and intended purpose, the product roadmap and the regulatory position are coupled. Which planned assay improvements, new claims, or design changes would count as significant, tipping the device out of the legacy regime and into full IVDR conformity assessment ahead of schedule, is a judgment that has to be made before the change is shipped rather than discovered afterward. A US developer used to continuous improvement has to price the regulatory cost of each change into the roadmap.
The third is the second market. Switzerland requires its own representative, its own importer, its own registration in swissdamed, and its own labeling treatment, and none of these is discharged by the European equivalents because the Mutual Recognition Agreement does not bridge the new regulations. Whether the Swiss chain of economic operators actually exists for each device on the Swiss market, whether a valid CH-REP mandate is in place, and whether the CHRN and device registrations have been obtained on time, are present-tense compliance facts rather than future deadlines.
The fourth is the coordination cost of two calendars that look identical at the outer dates and diverge underneath: a supply-interruption duty that exists in one regime and not the other, labeling requirements that are not word-for-word, and registration systems that go live weeks apart and do not feed each other. Whether a portfolio has been mapped device by device across both regimes, rather than managed as a single European project with Switzerland assumed to follow, tends to determine whether the next audit or distributor request produces a surprise.