A Basel-based manufacturer of surgical instruments had, until May 2021, shipped products across the Rhine to German hospitals as easily as across the street to the Universitätsspital. The regulatory frameworks were harmonized. The conformity assessments were mutually recognized. A single CE mark opened both markets.
That arrangement ended when the EU declined to update Chapter 4 of the MRA following implementation of the Medical Device Regulation. The political context (stalled institutional framework negotiations, competing priorities in Brussels and Bern) matters less to the manufacturer than the practical consequences. Swiss MedTech operates in regulatory territory that is simultaneously familiar and foreign: substantively harmonized but procedurally severed.
The bilateral package (Bilaterale III) initialed in May 2025 promises eventual restoration. But "eventual" may mean 2028 or later, subject to parliamentary approval and potential referendum. Until then, manufacturers face dual compliance burdens, separate registrations, and authorized representative requirements flowing in both directions across a border that products once crossed invisibly.
1. What Changed When the MRA Lapsed for Medical Devices?
The Agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment entered into force on 1 June 2002, as part of the Bilaterale I package.1MRA (SR 0.946.526.81). For medical devices, the agreement meant that Swiss conformity assessment bodies could certify devices for EU market access, EU certificates were recognized in Switzerland, and manufacturers faced no requirement to appoint authorized representatives in the other jurisdiction.
The EU's implementation of Regulation (EU) 2017/745 on medical devices (MDR) in May 2021 disrupted this framework.2MDR [2017] OJ L117/1. The European Commission declined to update Chapter 4 of the MRA, linking the technical update to unresolved institutional questions. Switzerland became a third country for MDR purposes from 26 May 2021, and for in vitro diagnostics under Regulation (EU) 2017/746 (IVDR) from 26 May 2022.
The cost of dual compliance is measurable; the cost of building infrastructure that a restored MRA would render unnecessary is not, and neither is the cost of failing to build it.
The December 2024 Breakthrough
Bilateral negotiations resumed in March 2024 and reached political agreement in December 2024, when the Federal Council determined that its negotiating objectives had been achieved. Negotiations were formally concluded with initialing of the agreements in May 2025. Following consultation that ended in October 2025, the Federal Council noted in December 2025 that a clear majority of participants supported the bilateral package.3Federal Council, Medienmitteilung (5 December 2025); EDA, Faktenblatt on MRA (13 June 2025).
The MRA medical devices chapter is slated for update once the Bilaterale III package enters into force. The Federal Council factsheets state that the new institutional elements will ensure the agreement is regularly adapted to developments in EU law; an update of Chapter 4 that makes the MDR and IVDR its covered legislation would restore mutual recognition of conformity assessments and, unless the updated chapter provides otherwise, eliminate the authorized representative requirement for Swiss manufacturers accessing the EU market.4Federal Council media release on the material conclusion of the Switzerland-EU negotiations (20 December 2024); EDA, Faktenblatt: Mutual Recognition Agreement (MRA) (13 June 2025).
The Timeline Problem
Parliamentary consideration is expected in late 2026. A referendum remains possible, indeed probable given the political significance. If requested, a public vote would not occur before 2027. Full ratification and entry into force could extend to 2028.
This timeline creates a strategic dilemma. Investments in dual compliance infrastructure (EU authorized representatives, parallel QMS documentation, EUDAMED and swissdamed registrations) may become unnecessary if the MRA is restored. But the restoration is not certain. A referendum could fail. Implementation could be delayed. Manufacturers cannot avoid investing in compliance; they can only choose how much to put into structures that three possible futures (full restoration, partial restoration, or continued third-country status) would treat very differently.
2. What Does Dual Compliance Require?
Swiss medical device legislation has tracked EU requirements since 2001. The Medizinprodukteverordnung (MepV; Medical Devices Ordinance) transposes MDR requirements into Swiss law; the Verordnung über In-vitro-Diagnostika (IvDV; In Vitro Diagnostics Ordinance) does the same for IVDR.5MepV (SR 812.213); IvDV (SR 812.219). The substantive requirements (classification, conformity assessment, clinical evaluation, post-market surveillance) are functionally equivalent.
But equivalence of substance does not produce equivalence of procedure. The MRA lapse severed the administrative linkages that allowed a single compliance exercise to satisfy both systems.
Parallel Requirements
Since the MRA lapse, Swiss manufacturers have had to meet the EU and Swiss requirements separately. EU market access under MDR/IVDR requires engagement with an EU notified body for conformity assessment, a Declaration of Conformity referencing EU regulations rather than Swiss law, and an EU-REP whose obligations extend beyond administrative formality. No notified body is involved, however, where the manufacturer may declare conformity on its own, as for Class I devices that are not sterile, have no measuring function and are not reusable surgical instruments (Art. 52(7) MDR) and for non-sterile Class A IVDs (Art. 48(10) IVDR). Registration in EUDAMED becomes mandatory from 28 May 2026; the database operates independently of any Swiss equivalent. Post-market surveillance and vigilance reporting flow to EU competent authorities under EU procedural rules.
The Swiss framework under MepV/IvDV mirrors much of the EU system but differs on certificates, registration, and vigilance reporting. Switzerland unilaterally recognizes EU notified body certificates under Art. 25(4) MepV (n 5), which treats certificates issued by EU/EEA-designated bodies as equivalent to certificates of Swiss bodies, subject to conformity-assessment-procedure equivalence and qualification equivalence of the issuing body. The recognition policy simplifies conformity assessment but imposes its own registration obligations through swissdamed, which has been the exclusive channel for economic operator registration since August 2024 and through which device registration becomes mandatory from 1 July 2026. Vigilance reporting runs to Swissmedic rather than to EU authorities, creating parallel reporting obligations for manufacturers operating in both markets.
The Asymmetry of Unilateral Recognition
Switzerland's unilateral recognition of EU notified body certificates deserves attention. Rather than requiring Swiss-designated conformity assessment bodies for the Swiss market, Switzerland accepts EU certificates, a policy choice that maintains Swiss market access for EU manufacturers without reciprocity.
This asymmetry shapes the bilateral negotiating dynamic: EU manufacturers face minimal additional burden serving the Swiss market (appointment of a CH-REP being the primary obligation), while Swiss manufacturers bear full third-country compliance costs for EU market access. The arrangement reflects Switzerland's interest in maintaining access to EU-certified devices for its healthcare system, but it also means the compliance burden falls disproportionately on Swiss industry.
The Cost of Third-Country Status
Swiss Medtech, the industry association, estimated the non-EU status burden at approximately CHF 114 million in initial costs and CHF 75 million annually, representing 2% and 1.4% respectively of the CHF 5.2 billion annual export volume from Switzerland to the EU.6Swiss Medtech, 'Swiss medtech downgraded to third country status' (26 May 2021). These figures, dating from 2021, capture direct compliance costs but may understate both the strategic costs of diverted management attention and the cumulative burden of requirements that have expanded since the initial assessment.
The burden falls unevenly across the industry. An SME with limited EU sales, perhaps 10–15% of revenue from a few German hospital customers, faces proportionally higher compliance costs than a large multinational with established EU infrastructure and dedicated regulatory affairs teams. The fixed costs of EU-REP appointment, EUDAMED registration, and parallel documentation do not scale with sales volume. For some smaller manufacturers, the compliance burden may exceed the margin on EU sales entirely, forcing market exit decisions that aggregate industry figures obscure.
Extended Transitional Periods
Both the EU and Switzerland have extended transitional periods for legacy devices, acknowledging notified body capacity constraints. Regulation (EU) 2023/607 extended timelines for devices with valid MDD/AIMDD certificates.7Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices [2023] OJ L80/24. Regulation (EU) 2024/1860 extended timelines for IVD devices. Switzerland amended MepV (1 November 2023) and IvDV (1 January 2025) to align with these extensions.
For Swiss manufacturers, the extended transitional periods delay certain recertification obligations, but the duty to comply with both systems remains.
The European Commission's proposal of December 2025 to simplify the MDR and IVDR may further ease the EU side of this burden. It would remove the five-year maximum validity of certificates, replacing recertification with periodic reviews, and would apply more proportionate requirements, including an exemption from clinical investigations, to well-established technology devices, a category whose criteria include a long history on the Union market.8European Commission COM(2025) 1023 final (16 December 2025). If adopted, these simplifications would reduce the EU compliance burden for legacy devices, though the two parallel systems would remain until the MRA is restored. The interaction with post-market surveillance obligations across both systems adds further complexity, since those requirements under the MDR apply in full to Swiss manufacturers as third-country operators accessing the EU market.
Clinical Investigation Implications
The market access analysis above focuses on devices placed on the market. But Swiss sponsors conducting clinical investigations in the EU face a parallel third-country burden. Under Art. 62(2) MDR, a sponsor not established in a Member State must designate a legal representative in the EU. The requirement sits within the broader Art. 62 ff. MDR clinical-investigation regime and is functionally equivalent to the EU-REP requirement for market access, but arises at the earlier clinical investigation stage.9Art. 62(2) MDR (n 2) (legal representative for sponsors not established in the EU). A Swiss manufacturer developing a novel device thus needs an EU legal representative before the product reaches the market, which adds a compliance step during development. For trilateral clinical investigations involving Swiss, EU, and UK sites, the contracts become considerably harder to structure (see the analysis of clinical trial agreements across Switzerland, the EU and the UK).
3. How Do Authorized Representative Requirements Flow in Both Directions?
Under the MDR, manufacturers not established in a Member State must designate an authorized representative in the EU.10Art. 11(1)–(3) MDR (n 2). The authorized representative assumes specified responsibilities and can be held jointly liable for defective devices where the manufacturer has failed to meet its obligations.
Since May 2021, this requirement applies to Swiss manufacturers accessing the EU market; the analysis of EU authorized representatives for Swiss manufacturers covers that change and the obligations under Art. 11 MDR. But the burden flows in both directions.
Swiss Authorized Representative (CH-REP)
Every manufacturer not established in Switzerland, EU, EEA and US manufacturers included, must designate a Swiss authorized representative (Schweizer Bevollmächtigter) to place medical devices on the Swiss market. The duty arises under Art. 51(1) MepV, and Art. 4(1)(g) MepV defines the role.11Art. 4(1)(g) MepV (n 5) (definition); Art. 51(1) MepV (appointment duty). The CH-REP performs analogous functions to the EU-REP: maintaining documentation, ensuring registration, cooperating with Swissmedic on vigilance matters.
A German manufacturer that previously shipped devices to Switzerland without local representation requires a CH-REP. A Swiss manufacturer shipping to Germany requires an EU-REP. Trade in both directions requires authorized representatives on both sides of a border that previously required neither.
Liability Considerations
Under Art. 11(5) MDR, where a manufacturer not established in a Member State has failed to comply with its obligations under Art. 10 MDR, the authorized representative becomes legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. The liability turns on two cumulative conditions: it does not attach to representatives of EU-established manufacturers, and it is triggered only by the manufacturer's own non-compliance. MDCG 2022-16 confirms that this liability is conditional; it arises only where manufacturer non-compliance is established and product liability under applicable national or EU law (such as Directive 85/374/EEC) is triggered.12MDCG 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) (Medical Device Coordination Group, October 2022).
The representative's liability affects both the choice of authorized representative and the terms of the contract between them. An EU-REP has a legitimate interest in verifying that the Swiss manufacturer maintains proper quality management systems, holds adequate liability insurance, and has fulfilled its documentation obligations. The CH-REP faces analogous considerations in reverse.
The revised Product Liability Directive (EU) 2024/2853, which Member States must transpose by December 2026, will extend the representative's liability further. Under the revised PLD, where the manufacturer is established outside the EU, the authorized representative is expressly among the economic operators who can be held liable for a defective product, alongside the importer; this marks a shift from Directive 85/374/EEC, and reflects a product-liability concept that overlaps with but is distinct from the MDR's own "economic operator" taxonomy.13Directive (EU) 2024/2853 on liability for defective products, to be transposed by 9 December 2026. For Swiss manufacturers, this means that the choice of EU-REP and the contractual indemnification provisions matter more; an EU-REP that may itself be liable for a defective product under the revised PLD will demand correspondingly stronger contractual protections (see the analysis of EU MDR compliance for Swiss MedTech on what the revised PLD means for manufacturers that follow the EU and Swiss rules in parallel).
The PRRC Requirement
Art. 15 MDR requires manufacturers to have a Person Responsible for Regulatory Compliance (PRRC) available within their organization. For a manufacturer outside the Union, MDCG 2019-7 Rev.1 expects the PRRC to be located outside the Union too, so a Swiss manufacturer's PRRC in Basel or Bern is what the guidance foresees.14MDCG 2019-7 Rev.1, Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) on a "person responsible for regulatory compliance" (PRRC). The guidance reads that requirement as employment by the manufacturer, except for a micro or small enterprise, which may rely on a PRRC from an external organization. The EU-REP needs a PRRC of its own under Art. 15(6) MDR, located in the Union. The guidance rules out one person in both roles, even within one group, because the EU-REP is meant to add a further level of scrutiny; where the manufacturer is a micro or small enterprise, its PRRC and the EU-REP's may not belong to the same external organization. Whether the mandate agreement addresses PRRC coverage, and how it allocates liability for regulatory compliance failures arising from the divided responsibility, are questions the regulatory framework leaves to the parties.
The Mandate Structure
The mandate is valid only when the authorized representative accepts it in writing, and it covers at least all devices of the same generic device group (Art. 11(2) MDR). The tasks that may be delegated to an authorized representative are specified in Art. 11(3) MDR; certain manufacturer obligations under Art. 10 MDR cannot be delegated regardless of the mandate terms.
The mandate's terms interact with uncertainties the regulation does not address. The competencies a representative requires depend on the manufacturer's product portfolio, but the portfolio's regulatory status may shift as transitional provisions expire. The allocation of responsibilities between manufacturer and representative assumes stable regulatory requirements; what happens when those requirements diverge between the Swiss and EU frameworks remains contractually uncharted. And a restored MRA would eliminate the EU-REP requirement unless the updated medical devices chapter provides otherwise, a change so abrupt that an agreement drafted for permanence may not accommodate it. Whether a mandate can allocate PRRC coverage, liability under the revised PLD and the consequences of MRA restoration in a way both parties accept is a question the regulation leaves entirely to the parties.
4. Why Do Parallel Database Registrations Persist?
The MRA lapse extended to information infrastructure. Swissmedic lost access to EUDAMED when Switzerland became a third country, necessitating development of an independent Swiss database.
swissdamed
Swissmedic has operated swissdamed, the Swiss Database on Medical Devices, since August 2024. The system provides transparency regarding medical devices on the Swiss market and the economic operators responsible for them.
The actors module went live on 6 August 2024 and has since served as the exclusive registration channel for Swiss manufacturers, importers, authorized representatives, and assemblers of systems and procedure packs, all of which must register as economic operators. The UDI devices module extends this to product-level registration: voluntary since August 2025, it becomes mandatory from 1 July 2026 for medical devices, IVDs, and systems or procedure packs.15Swissmedic swissdamed guidance (December 2025).
A transitional period extends until 31 December 2026 for most devices. However, devices subject to vigilance reporting (serious incidents, field safety corrective actions, or trend reporting) must be registered by 1 July 2026 without transition.
EUDAMED
The European Commission confirmed in November 2025 that EUDAMED modules for actor registration, UDI/device registration, notified bodies and certificates, and market surveillance are functional.16Commission Decision (EU) 2025/2371 [2025] OJ L 2025/2371. Mandatory registration of EU economic operators and devices will apply from 28 May 2026, with transition until 28 November 2026.
The Parallel Burden
swissdamed has been designed for alignment with EUDAMED. Most data prepared for EUDAMED can be reused; the XML format is compatible. But the databases are not connected. Registration in one does not satisfy obligations in the other.
A Swiss manufacturer selling in both markets maintains registrations in both systems. An EU manufacturer with a CH-REP serving the Swiss market registers in both systems. The data may be substantially identical, but the submission, maintenance, and update obligations are independent. For AI-enabled medical devices, the database registration burden intersects with broader regulatory questions about algorithmic change management and post-market monitoring that neither EUDAMED nor swissdamed was originally designed to address.
The database requirements apply equally to medical devices and IVDs.
5. Where Do IVDs Face Different Transitional Challenges?
The IVD market presents distinct challenges that the medical device analysis does not fully capture.
Different Timelines
The IVDR became applicable on 26 May 2022, one year after the MDR. The Chapter 4 MRA coverage for IVDs (previously under Directive 98/79/EC, the IVDD) ceased on that date.17Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices [1998] OJ L331/1 (IVDD). Swiss manufacturers of IVDs have been operating outside the mutual recognition framework for a shorter time than medical device manufacturers, but face different transitional provisions.
Classification Migration
The IVDR substantially restructured IVD classification. Devices whose conformity assessment under the IVDD did not require a notified body may require one under the IVDR. The transitional periods reflect this migration, with Class D devices (highest risk) allowed to be placed on the market until December 2027, Class C devices until December 2028, and Class B and sterile Class A devices until December 2029.18Art. 110(3b) IVDR [2017] OJ L117/176, as amended by Regulation (EU) 2024/1860 (n 16).
Switzerland has aligned IvDV transitional provisions with these timelines. Since the January 2025 IvDV amendment, the Swiss authorized representative's details for an IVD not intended for self-testing may appear, without a time limit, on a document accompanying the device rather than on its label, which reduces the administrative burden for those devices.
Capacity Constraints and Notified Body Dynamics
Notified body capacity for IVDR certification remains severely constrained. As of early 2026, the NANDO database lists roughly 19 IVDR-designated notified bodies, compared to roughly 50 for the MDR; even the MDR figure represents a significant reduction from the approximately 80 notified bodies that operated under the predecessor MDD. The European Commission itself invoked this shortage when it extended the IVDR transition timelines.19European Commission, 'NANDO' (accessed January 2026). The limited capacity affects both EU and Swiss manufacturers, but Swiss manufacturers face the additional complexity of selecting EU-established notified bodies for EU market access while potentially using different bodies for Swiss market compliance.
The competitive dynamics of the notified body market affect manufacturer options. Some EU notified bodies have established Swiss subsidiaries or partnerships; some Swiss conformity assessment bodies maintain EU relationships that survived the MRA lapse in modified form. These cross-border presences may simplify coordination for manufacturers seeking to maintain relationships with assessment bodies familiar with their products and quality systems, though the formal requirements for EU and Swiss market access remain distinct regardless of corporate relationships between assessment providers.
6. What Strategic Options Exist, and What Do They Cost?
Swiss manufacturers face strategic decisions that will shape their competitive position for years to come. The options involve trade-offs between cost, control, flexibility, and risk.
Parallel Compliance
Maintaining full compliance with both Swiss and EU regimes independently preserves maximum market flexibility. The approach accepts the cost burden documented by Swiss Medtech in exchange for continued access to both markets without structural changes.
How much to invest is hard to judge. Compliance infrastructure built for permanence becomes a sunk cost if the MRA is restored; infrastructure built for transition may prove inadequate if it is not. Whether the QMS built for dual documentation can be unwound without disruption, and whether the resources spent on parallel compliance can be recovered in any scenario, depend on the circumstances of each organization, which a generic cost-benefit analysis cannot capture.
EU Subsidiary as Manufacturer of Record
Establishing an EU-based legal entity as the manufacturer of record eliminates the EU-REP requirement and positions the manufacturer as an EU economic operator. The structure may simplify EU market access while complicating Swiss market access (since the EU entity would require a CH-REP).
The structure introduces its own complications. Tax treatment, intellectual property allocation, and liability insurance coverage all shift when the manufacturer of record changes jurisdiction. A subsidiary set up for EU market access may create transfer pricing risk, and splitting development in Switzerland from manufacturing by the EU entity raises product liability questions that neither jurisdiction's rules fully anticipate.
Contract Manufacturing
Partnering with EU-based contract manufacturers for EU-market products can shift certain regulatory obligations to the contract manufacturer. The approach may reduce the Swiss company's direct compliance burden while introducing supply chain dependencies.
The regulatory burden shifts, but it does not disappear. Quality control across manufacturing partners, product claims tied to manufacturing origin, and the commercial risk of supply chain dependence on a single EU partner all present vulnerabilities that the compliance savings alone do not offset. Exit scenarios, whether the contract manufacturer terminates the relationship or is acquired, receive less attention in initial structuring than they deserve.
Market Prioritization
Focusing resources on one market and accepting limitations in the other represents a strategic retreat. Some manufacturers may conclude that the EU compliance burden exceeds the market opportunity, particularly for products with limited EU sales or facing intense competition.
The implications extend beyond the market being abandoned. Customer relationships, re-entry costs if circumstances change, and the signaling effect of withdrawal on other commercial partners, including notified bodies and distributors, interact in ways that make market exit decisions far less reversible than they appear at the point of decision.
FDA Pathway Development
Switzerland is exploring acceptance of FDA-approved medical devices on the Swiss market. After the Swiss Parliament adopted Motion 20.3211 (Damian Müller) on 28 November 2022, a Federal Council working group comprising representatives of the BAG, Swissmedic, SECO, and the EDA developed conditions for FDA-authorized device market access. In April 2025, the Federal Council defined guidelines for implementation, including Swiss data protection compliance, quality management system requirements, and post-market surveillance plans.20Bundesamt für Gesundheit, 'The Federal Council defines guidelines for expanding the supply of medical devices' (30 April 2025). Implementation timelines remain uncertain.
The scope of any FDA recognition pathway (which device categories it covers, what Swiss-specific requirements supplement FDA approval, and how post-market surveillance would integrate across regulatory systems that were not designed to interoperate) remains undefined. Whether the pathway simplifies compliance or adds a third set of rules depends on implementation details that have not yet been settled.
Alternative Mutual Recognition
The FDA pathway is not the only alternative recognition framework. Switzerland and the United Kingdom maintain mutual recognition arrangements across two agreements covering eight product sectors in total, but medical devices are not among them.21CH-UK mutual recognition: the MRA chapter of the 2019 trade agreement (motor vehicles, GLP, GMP) and the MRA concluded in 2022 (five further sectors), the three sectors moving into that MRA by Federal Council decision of 5 December 2025; medical devices covered by unilateral Swiss measures only. For medical devices, Switzerland applies unilateral measures recognizing certificates from UK conformity assessment bodies that were designated under the CH-EU MRA as of 31 December 2020. This unilateral recognition, which can be withdrawn without bilateral consent, reduces but does not eliminate the regulatory burden compared to full third-country status. Australia and Japan represent additional jurisdictions where mutual recognition discussions could theoretically proceed, though no active negotiations are publicly underway.
These alternative frameworks matter less for EU market access, which remains the dominant commercial concern, than for demonstrating that mutual recognition remains achievable where political conditions permit. The UK market adds its own rules: a Swiss manufacturer selling in the UK, the EU and Switzerland deals with three separate regulatory regimes, each with its own authorized representative requirements and database registrations.
7. Why Must These Decisions Be Made Together?
The regulatory environment for Swiss MedTech export will remain unsettled through at least 2027 and potentially beyond. The Bilaterale III package is the most significant development since the MRA lapse. But significance is not certainty. Its implementation is neither immediate nor guaranteed.
Economic operator status under Swiss and EU frameworks may appear straightforward (manufacturer here, authorized representative there), but the liability chains, documentation obligations, and vigilance reporting pathways diverge in ways that affect organizational structure. An authorized representative agreement drafted without accounting for the possibility of MRA restoration may lock in costs that become unnecessary; an agreement drafted with too much flexibility may fail to provide the regulatory certainty that compliance requires.
Database Registration Bottleneck
The convergence of database registration deadlines in mid-2026 creates a compliance bottleneck whose implications depend on product portfolio characteristics. A manufacturer with hundreds of legacy devices faces different registration sequencing challenges than one with a focused portfolio of newly certified products. Registration deadlines also have to fit product launch schedules, in particular for devices subject to vigilance reporting, which must be registered by 1 July 2026.
Building the QMS for One Framework or Two
How to structure the quality management system is the central dual compliance question. Build for one framework, and documentation diverges. Build for two, and the investment may prove unnecessary if the MRA is restored. The transitional period extensions complicate this calculus further; legacy device recertification strategies must account for timelines that interact with product lifecycle decisions in ways specific to each device category.
The Stranded Asset Dilemma
Alternative market access structures (EU subsidiaries, contract manufacturing, market prioritization) represent strategic choices that extend beyond regulatory compliance into corporate structure, intellectual property positioning, and commercial relationships. The Bilaterale III package's uncertain timeline makes these decisions more difficult, not less: investments in alternative structures may become stranded assets if restoration occurs, but failure to invest may leave the organization uncompetitive if it does not.
The timing of these decisions, and the assumptions underlying them, will shape competitive positioning throughout the transitional period and beyond. Other EU rules put similar pressure on Swiss manufacturers: the NIS2 Directive's cybersecurity requirements reach Swiss suppliers indirectly, through the supply chain obligations of their EU customers, and so affect connected medical devices whatever the MRA's status (see the analysis of NIS2 for connected medical devices). Whether through the lapse of mutual recognition or through supply chain obligations, EU requirements reach Swiss industry by way of the EU market and EU customers, not by way of Swiss law. The Bilaterale III package may ease this for medical devices but cannot resolve it for the wider Swiss-EU regulatory relationship.