Swiss medical device manufacturers operate in a regulatory environment that differs fundamentally from that of their European competitors. The European Medical Device Regulation has been applicable since 26 May 2021, but Switzerland's relationship with this framework remains complicated by the non-updated Mutual Recognition Agreement.1Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices [2017] OJ L117/1. What appears to be a single regulatory transition is, for Swiss manufacturers, a dual-track compliance challenge with costs and complexities that European counterparts do not face.
1. What Does Third-Country Status Mean for Swiss Manufacturers?
The Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (MRA), Chapter 4 (Medical Devices), previously facilitated mutual recognition of conformity assessments, enabling certificates issued by Swiss-designated conformity assessment bodies to be accepted in the EU and those issued by EU notified bodies to be accepted in Switzerland.2Agreement on mutual recognition in relation to conformity assessment [2002] OJ L114/369, ch 4; European Commission DG SANTE, 'Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices' (Brussels, 26 May 2021) (Commission position that, absent an Institutional Framework Agreement, a full update of the MRA cannot be considered). The European Commission's decision not to update Chapter 4 to reference the MDR effectively suspended mutual recognition from 26 May 2021.
Following the Swiss Federal Council's cessation of Institutional Framework Agreement negotiations, the European Commission declined to update the MRA's medical devices chapter to align with the MDR. Since 26 May 2021, Switzerland has been treated as a third country for purposes of the MDR, and reciprocally, the EU is treated as a third country under Swiss law.
The manufacturer that once operated seamlessly across Swiss and EU markets maintains two parallel compliance structures, two authorized representative relationships, and two sets of regulatory documentation obligations.
The practical consequences are substantial. Swiss manufacturers placing devices on the EU market must appoint an authorized representative established in the EU, register in EUDAMED (when functional), and ensure their EU-AR fulfills the obligations specified in Art. 11(3) MDR. Conversely, EU manufacturers placing devices on the Swiss market must appoint a Swiss authorized representative (CH-REP) and register with Swissmedic.3Art. 51–54 MepV (SR 812.213) on economic operator obligations; Art. 55 MepV on Swissmedic registration.
This is not merely administrative duplication. The authorized representative bears significant liability exposure. The EU-AR must be named in the declaration of conformity, appears in EUDAMED, and, where the manufacturer is not established in a Member State and has not complied with its obligations under Art. 10 MDR, can be held jointly and severally liable for defective devices (Art. 11(5) MDR). The liability analysis is examined in detail in Insight 05. Finding qualified entities willing to accept this exposure, particularly for higher-risk device classes, has become a commercial challenge in itself.
The revised Product Liability Directive (PLD, Directive (EU) 2024/2853), applicable from 9 December 2026, adds a further liability dimension: the EU-AR can be held liable as an economic operator where no importer is established in the EU.4Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024, Art. 8; see also Insight 04. For Swiss manufacturers, the resulting liability chain (manufacturer → EU-AR → importer) creates allocation questions that Art. 11(5) MDR only partially addresses, requiring contractual arrangements that account for both MDR regulatory liability and PLD product liability simultaneously.
Switzerland has maintained regulatory equivalence with the MDR through the Medizinprodukteverordnung (Medical Devices Ordinance, MepV), amended in November 2023 to align Swiss transition periods with Regulation (EU) 2023/607.5MepV (n 3), as amended November 2023; BAG, Revision der Medizinprodukteverordnung. But equivalence of technical requirements does not restore the mutual recognition that made cross-border trade efficient. The infrastructure duplication persists.
In 2024, Switzerland and the EU resumed negotiations under the "Bilaterale III" framework,6Federal Council, 'Negotiations with the EU: Federal Council adopts negotiating mandate' (press release, 8 March 2024). but the medical devices chapter is one component of a broader package including institutional questions and electricity market access. Whether manufacturers plan on the basis that third-country status persists indefinitely or factor in MRA restoration affects compliance infrastructure investment, and neither assumption is without risk.
2. When Do Legacy Devices Lose Market Access?
The MDR's original transition framework proved unworkable. Notified body capacity was insufficient, manufacturer preparedness was inadequate, and the May 2024 deadline threatened to remove safe, certified devices from the market. Regulation (EU) 2023/607, adopted in March 2023, fundamentally restructured the transition timeline.7Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending MDR transitional provisions [2023] OJ L80/24.
The extended deadlines are risk-class dependent. Class III devices and Class IIb implantable devices face a deadline of 31 December 2027. However, certain well-established technologies listed in Art. 120(3a)(a) of the amended MDR (sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors) are not subject to the earlier 2027 deadline despite their Class III or IIb implantable classification; these devices instead benefit from the longer 31 December 2028 deadline applicable to lower-risk classes.8MDR (n 1), Art. 120(3a)(a), as amended by Regulation (EU) 2023/607 (n 7). The remaining Class IIb devices, Class IIa devices, and Class I devices requiring notified body involvement under the MDR (sterile devices, devices with measuring function, reusable surgical instruments) also have until 31 December 2028.
These extended deadlines are not automatic. The device must have held a valid MDD or AIMDD certificate as of 26 May 2021, and manufacturers were required to submit applications to MDR-designated notified bodies by 26 May 2024 and execute conformity assessment agreements by 26 September 2024. Both deadlines have passed, and manufacturers who missed them cannot benefit from the extended transition regardless of prior certification status.
Even for manufacturers who satisfied these procedural gates, ongoing eligibility remains conditional. The device must continue complying with the applicable directive, with no significant changes in design or intended purpose. The manufacturer must have implemented a quality management system meeting Art. 10(9) MDR requirements. Failure on any of these dimensions collapses the extended timeline, a risk that compounds as the 2027 and 2028 deadlines approach.
The "substitute device" concept introduced by 2023/607 creates additional complexity. Where a manufacturer intends to replace a legacy device with a successor, the substitute device may benefit from the extended transition if certain conditions are met, but the boundaries of permissible substitution remain subject to interpretation, and a manufacturer that miscalculates the line between permissible evolution and impermissible redesign risks losing transition eligibility entirely, with no procedural mechanism to recover it.
For manufacturers who satisfied the May and September 2024 conditions, the question becomes strategic: how quickly to pursue full MDR certification versus how long to operate under extended legacy certificates. Legacy devices cannot undergo significant changes in design or intended purpose during the transition period. A manufacturer that completes MDR certification earlier gains freedom to evolve the product; one that relies on extended transition preserves resources but accepts design constraints.
Swiss manufacturers of in vitro diagnostic medical devices face a parallel transition under Regulation (EU) 2017/746 (IVDR), with corresponding provisions in the Swiss In-vitro-Diagnostika-Verordnung (IvDV).9Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices [2017] OJ L117/176 (IVDR); IvDV (SR 812.219). The dual-track compliance challenges identified for MDR apply equally to IVDR, compounded by the shift from list-based to risk-based classification.
On 8 September 2025, the European Commission opened a Call for Evidence on a targeted revision of the MDR and IVDR, signalling a forthcoming simplification package directed at re-certification burden, well-established technologies, modified PRRC requirements for small and medium-sized enterprises, and reform of certificate-validity rules, with Commission adoption anticipated by year-end.10European Commission, 'Targeted revision of the EU rules for medical devices and in vitro diagnostic medical devices' (Call for Evidence, Ares(2025)7425764, 8 September to 6 October 2025). Whether the package emerges in the form previewed, and on what terms, remains to be seen, but the prospect introduces a variable that existing transition planning may not have factored in.
3. Can Notified Bodies Process the Backlog in Time?
The notified body capacity constraint is not merely historical context; it remains an operational reality. As of November 2025, over 50 notified bodies hold MDR designation, a substantial increase from the single-digit numbers available during the initial transition period, but still insufficient to process the volume of technical documentation reviews required before the 2027 and 2028 deadlines.11European Commission, 'NANDO: New Approach Notified and Designated Organisations Information System', MDR designated bodies; Team-NB, 'Position Paper on the MDR Certification Process' (18 December 2024) (industry-association source for review-timeline expectations). The geographic concentration compounds the access problem: the majority of MDR-designated notified bodies are established in Germany, Italy, and the Netherlands, with meaningful capacity also in France and Poland. For Swiss manufacturers, already operating as third-country applicants, the practical consequence is that securing notified body engagement requires navigating both the capacity bottleneck and the cross-border logistics of working with bodies that may prioritize domestic or EU-established manufacturers.
The implications compound over time. Technical documentation review timelines vary considerably depending on device complexity, clinical data adequacy, and notified body capacity. While Swissmedic and industry associations have cited timelines of 12–18 months for complex device reviews,11Team-NB, Position Paper on the MDR Certification Process (18 December 2024) (n 11). actual experiences vary and queue depth at specific notified bodies may extend or compress these estimates. A manufacturer submitting in early 2026 for a Class III device faces meaningful risk of not completing certification before the December 2027 deadline. The margin for iteration, for addressing notified body questions, revising clinical evaluation reports, or supplementing post-market data, compresses as deadlines approach.
The strategic dimension extends beyond individual manufacturers. A manufacturer that achieves MDR certification before competitors retains market access while competitors' products may face gaps. The transition period is not merely a compliance exercise; it is a competitive positioning event.
4. Does Legacy Clinical Data Survive MDR Scrutiny?
The MDR's clinical evaluation requirements represent a substantive change from the MDD framework, not merely an administrative one. Annex XIV specifies clinical evaluation procedures with considerably more rigor than the prior regime, and the threshold for demonstrating conformity with general safety and performance requirements has risen correspondingly.
For legacy devices, the clinical data accumulated under the MDD must be assessed against MDR standards. Equivalence claims under Art. 61(5) MDR, requiring technical, biological, and clinical equivalence with full access to comparator data, face heightened scrutiny that eliminates the practice of relying on literature-based comparisons to competitor devices. Post-market clinical follow-up (PMCF) has evolved from a general obligation to a device-specific, proactive requirement feeding into continuous clinical evaluation. For implantable devices and Class III devices, clinical investigation under ISO 1415512ISO 14155:2020, Clinical investigation of medical devices for human subjects – Good clinical practice. may be required where existing data is insufficient. The clinical evidence requirements under the MDR, including the heightened scrutiny of equivalence claims, proactive PMCF obligations, and post-market surveillance cycles, are examined in detail in Insight 11 and Insight 12.
For Swiss manufacturers, the dual-track reality adds a distinctive clinical evidence dimension. Clinical investigations conducted at Swiss sites under the Swiss Human Research Act (HFG) generate data acceptable to Swissmedic, but the same investigations require separate authorization under MDR Chapter VI if EU sites are involved. Where clinical data was generated exclusively under Swiss regulatory oversight, its acceptability for MDR certification depends on the notified body's assessment of the study's alignment with EU requirements, an assessment that is not guaranteed. Software as a Medical Device (SaMD) developers face a compounding challenge: MDR Rule 11 frequently results in higher classification than the equivalent MDD classification, triggering clinical evidence requirements that software companies may not have anticipated, a classification shift that compounds the clinical evidence burden.
5. How Do Dual Database Obligations Converge in 2026?
Switzerland's exclusion from EUDAMED and the subsequent development of parallel database infrastructure creates dual registration obligations that converge in 2026.
EUDAMED: On 27 November 2025, the European Commission published Decision (EU) 2025/2371, confirming that the first four EUDAMED modules are fully functional.13Commission Decision (EU) 2025/2371 of 26 November 2025 [2025] OJ L 2025/2371; Regulation (EU) 2024/1860 of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed [2024] OJ L 2024/1860. This triggered a six-month transition period under Regulation (EU) 2024/1860. From 28 May 2026, the following modules become mandatory: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. For devices placed on the market before 28 May 2026, manufacturers have until 28 November 2026 to complete device registration. Economic operators must obtain a Single Registration Number (SRN) through the Actor Registration module before other submissions can proceed.
swissdamed: The Swiss Database on Medical Devices operates on a parallel timeline. The actors module became operational in August 2024 for registration of economic operators. The UDI devices module became available for voluntary use in August 2025. Mandatory device registration enters into force on 1 July 2026, with a transition period extending to 31 December 2026.14Swissmedic, 'Deadline for Device Registration in swissdamed' (2025); Art. 17(5) MepV (n 3); Art. 16(5) IvDV (n 9), as amended 20 November 2024. Devices subject to vigilance reporting (serious incidents, field safety corrective actions, or trend reports) must be registered immediately from 1 July 2026 without benefit of the transition period.
Two EUDAMED modules remain non-functional: the Vigilance module and the Clinical Investigation module. Until these become operational, vigilance reporting continues through existing national channels, a distinction that affects infrastructure investment decisions.
For manufacturers operating in both markets, this creates converging database obligations: EUDAMED registration from 28 May 2026, swissdamed registration from 1 July 2026. The data fields are aligned with the EU framework, but there is no interface between the systems. Information must be entered separately into each database.
Both the MDR and the MepV require Unique Device Identification, with UDI data submitted separately to each database despite mirrored technical requirements.
For Swiss manufacturers exporting to the EU, the cost structure includes EU authorized representative fees, EUDAMED registration, notified body fees for MDR certification, and clinical evaluation to MDR standards. For EU manufacturers importing to Switzerland, the parallel applies: CH-REP fees, swissdamed registration, and Swiss-specific documentation.
6. Where Do Compliance Costs Become Structural?
The Permanent Cost Shift
The MDR transition is not a one-time compliance project; it is a permanent shift in the regulatory cost structure for medical devices. What was once a periodic certification exercise has become a continuous operational burden, and the full weight of that burden remains difficult to quantify in advance. For Swiss manufacturers maintaining dual-track compliance, the cost multiplier is structural: EU-AR fees, notified body certification, EUDAMED registration, and MDR-format technical documentation represent a layer of expense that EU-based competitors do not bear for domestic market access.
Cascading Vulnerabilities
The interconnections between compliance domains create cascading vulnerabilities that standard project planning rarely captures. Notified body timelines affect product development roadmaps, which affect clinical evidence requirements, which affect post-market surveillance commitments, which feed back into notified body interactions. A delay in one domain propagates unpredictably through others. The constraint that legacy devices cannot undergo significant design changes during the extended transition period means that commercial flexibility diminishes precisely when competitive pressure intensifies.
Clinical Evidence Gaps
Clinical evidence accumulated under MDD-era assumptions may not survive MDR scrutiny, but the gap between what exists and what the MDR requires often becomes visible only during notified body review, when timelines are already compressed and remediation options constrained. Equivalence claims that seemed defensible under the directives face heightened challenge under Art. 61(5) MDR, particularly where contractual access to comparator data was never secured.
PRRC Governance
Art. 15 MDR's Person Responsible for Regulatory Compliance (PRRC) requirement creates named individual accountability that did not exist under the MDD. Yet the role's authority within corporate structures varies considerably; where regulatory affairs remains a downstream documentation function rather than a strategic input, the PRRC's nominal responsibility may exceed their actual influence. Whether the PRRC holds sufficient seniority to block product decisions that create regulatory exposure complicates the liability picture in ways many organizations have not addressed.
Compliance as Operating Cost
The regulatory landscape has shifted from compliance-as-checkbox to compliance-as-operating-cost. How that cost is absorbed, and whether it is absorbed at all, depends on variables that extend well beyond the technical requirements of the MDR itself. For niche device categories with limited revenue potential, the permanent cost increase may render EU market access commercially unviable, a de facto market exit driven not by regulatory prohibition but by economic calculation.