A Swiss manufacturer completes development of a Class IIa medical device. Technical documentation: comprehensive. Clinical evaluation: robust. Quality management system: certified. The path to EU market access requires one additional element: designation of an authorized representative under Art. 11 of Regulation (EU) 2017/745.1Art. 11 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices [2017] OJ L117/1 (MDR). The requirement seems administrative. The implications are not.
1. What Does the Regulatory Mandate Require?
Swiss manufacturers occupy a particular position in the EU regulatory architecture. Switzerland is neither an EU Member State nor a participant in the European Economic Area. The bilateral Mutual Recognition Agreement that once facilitated device access to the EU market has lapsed with respect to medical devices and IVDs.2Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment [2002] OJ L114/369, ch 4. Mutual recognition ceased 26 May 2021 when MDR became applicable. This places Swiss manufacturers in the same regulatory category as those from any other third country: the United States, Japan, or China.
Art. 11 MDR establishes that manufacturers not established in the Union must designate an authorized representative within the Union before placing a device on the market. The authorized representative must be designated by written mandate. But what constitutes an adequate mandate? Art. 11(3) MDR enumerates the minimum tasks the mandate must cover, spanning documentation verification, regulatory liaison, corrective action coordination, and incident reporting.3Art. 11(3)(a)–(h) MDR enumerates verification of conformity documentation, document availability for authorities, forwarding of authority requests, cooperation on corrective actions, and incident/complaint reporting. This statutory list defines regulatory compliance; it does not specify how these obligations translate into contractual terms between commercial parties with potentially divergent interests.
The regulatory text creates obligations. It does not create the contractual architecture necessary to fulfill them.
The IVDR imposes parallel requirements for in vitro diagnostic medical devices, mutatis mutandis.4Art. 11 Regulation (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). A Swiss manufacturer producing both medical devices and companion diagnostics faces the question of whether a single authorized representative can serve both roles, whether separate representatives create coordination risks, and whether the liability exposure differs between the two regulatory regimes. The IVDR transition periods add specific timing pressure: legacy IVDs are being reclassified under the new risk-based framework, with application submission deadlines running to May 2025 for class D devices, May 2026 for class C, and May 2027 for class B, and, following Regulation (EU) 2024/1860, market placement end dates extended to December 2027, December 2028, and December 2029 respectively.5Art. 110(3) IVDR, as amended by Regulation (EU) 2022/112 and further extended by Regulation (EU) 2024/1860. The May dates are application submission deadlines; market placement end dates run to December 2027/2028/2029. Swiss IVD manufacturers face the acute combination of MRA lapse and IVDR reclassification: devices that previously entered the EU market without an authorized representative now require one precisely during a transition period when the product's classification, and therefore the scope of the AR's verification obligations, may itself be shifting.
The EU regulatory picture is only half of the compliance obligation. On the Swiss-market side, the revised Medizinprodukteverordnung (MepV) partially aligns Swiss domestic requirements with the MDR, creating parallel obligations that the manufacturer must satisfy simultaneously.6Medizinprodukteverordnung (MepV) vom 1. Juli 2020 (SR 812.213), in force since 26 May 2021, aligning Swiss medical device regulation with essential EU MDR requirements. Where the two frameworks overlap (vigilance reporting, technical documentation standards, quality management system requirements), the manufacturer can leverage shared compliance infrastructure, maintaining a single technical file that satisfies both Swissmedic and the notified body. Where they diverge (Swissmedic registration versus EUDAMED registration, different post-market surveillance reporting timelines, cantonal enforcement mechanisms versus EU market surveillance coordination), the manufacturer faces dual-track obligations that the AR mandate alone cannot resolve. A comprehensive compliance architecture must map both tracks and identify which obligations the AR covers and which remain the manufacturer's direct responsibility toward Swissmedic.
2. How Does Conditional Liability Attach Under Art. 11(5) MDR?
Art. 11(5) MDR provides that where the manufacturer is not established in a Member State and has not complied with its obligations under Art. 10 MDR, the authorized representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.7Art. 11(5) MDR. The provision is conditional: liability attaches only where the manufacturer lacks EU establishment and has failed to meet Art. 10 MDR obligations. The conditionality matters: this is not automatic joint liability but a consequence triggered by manufacturer non-compliance. Yet the provision raises immediate questions. Under which Member State's law is this liability assessed? If a French patient suffers injury from a device manufactured in Switzerland and represented by a German authorized representative, the choice of law determination alone involves multiple connecting factors.
The joint and several liability under Art. 11(5) MDR applies "on the same basis as" the manufacturer, but the substantive product liability regime is shifting. From December 2026, national laws transposing Directive (EU) 2024/2853 (the new Product Liability Directive, PLD) will introduce presumptions of defectiveness and causation.8Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products [2024] OJ L 2024/2853, replacing Council Directive 85/374/EEC. Transposition by 9 December 2026. Critically, the new PLD explicitly includes the "authorized representative" within its definition of liable economic operators (Art. 8 PLD), a deliberate legislative choice that closes a gap left by the outgoing 1985 Directive, under which the AR's status in the product liability chain was ambiguous. The consequence is direct: authorized representatives face product liability exposure not merely as a conduit of the manufacturer's liability under Art. 11(5) MDR, but as liable economic operators under the new PLD itself. Under Art. 8 PLD, where the manufacturer is established outside the Union, the importer and the authorized representative are each liable, with the fulfilment service provider liable only where neither is established within the Union. The authorized representative's exposure therefore attaches by virtue of the manufacturer's non-EU establishment, whether or not an EU importer sits in the supply chain, the typical position for Swiss manufacturers without one. An authorized representative accepting mandates from multiple Swiss manufacturers may face aggregate liability exposure that individual indemnification agreements do not contemplate.
3. Which Law Governs, and Where Are Claims Enforced?
The choice of law analysis extends in two directions. Before EU Member State courts, the parties may select governing law for the mandate agreement under Regulation (EC) No 593/2008 (Rome I), but that choice does not determine the law applicable to product liability claims, which follows Regulation (EC) No 864/2007 (Rome II) and applies a cascading hierarchy that begins with the law of the injured person's habitual residence.9Regulation (EC) No 593/2008 (Rome I) [2008] OJ L177/6; Regulation (EC) No 864/2007 (Rome II) [2007] OJ L199/40, Art. 5 (product liability). These regulations govern choice of law before EU courts; if a dispute is heard before a Swiss court, Swiss private international law (IPRG) applies instead: Art. 116 IPRG for contractual obligations, Art. 135 IPRG for product liability. A mandate agreement governed by German law does not prevent French product liability law from applying to claims arising from injuries in France. The authorized representative's exposure thus depends on which Member States' markets the device enters, a factor potentially outside the representative's control.
Enforcement of an EU Member State judgment against a Swiss manufacturer implicates the Lugano Convention framework, though the practical obstacles depend on the specific judgment, the enforcement Member State, and the manufacturer's Swiss assets.10Convention on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters [2007] OJ L339/3 (Lugano Convention). Switzerland remains a party; however, enforcement pathways and potential defenses vary by canton and judgment type. The authorized representative, remaining within EU jurisdiction and directly reachable by claimants, bears practical enforcement risk that may exceed its contractual indemnification rights against a manufacturer outside the EU enforcement perimeter. The asymmetry is structural: the injured party will pursue the EU-based representative because enforcement is straightforward, while the representative's recourse claim against the Swiss manufacturer must cross back over the Lugano framework, a path that adds delay, cost, and uncertainty even where the Convention applies.
4. Can Indemnification and Insurance Close the Gap?
The contractual response (an indemnification clause) appears obvious. The manufacturer indemnifies the representative against product liability claims. But indemnification presupposes the manufacturer's continued solvency and accessibility. If the manufacturer maintains EU assets or subsidiary operations, indemnification may provide meaningful protection: claims can be pursued, judgments enforced. If the manufacturer lacks EU presence and faces financial difficulty, the representative's contractual rights become practically unenforceable. The representative bears the exposure; the indemnification becomes pro forma.
The MDR does not specify whether authorized representatives must maintain product liability insurance, nor at what coverage level. The question is more complex than it appears. A Swiss manufacturer's standard product liability policy (typically written under Swiss law and denominated in CHF) may not extend to the representative's independent liability under Art. 11(5), which arises under EU regulatory law and may be assessed under any Member State's transposition of the new PLD. The policy's territorial scope, the definition of "insured party," and the trigger mechanism (occurrence vs. claims-made) all determine whether coverage actually follows the liability path from injured party through representative to manufacturer.
Representatives serving multiple manufacturers face a further dimension. Should coverage be per-manufacturer, per-product category, or aggregate? A single high-value claim against one manufacturer's device could exhaust aggregate limits, leaving the representative exposed on mandates from other manufacturers whose products were not involved. Swiss insurance market practice had not, as of September 2025, converged on standard terms for this arrangement; coverage is typically negotiated bespoke, with premiums reflecting the representative's assessment of each manufacturer's risk profile rather than any established actuarial model for AR liability.
5. What Contractual Architecture Does the Mandate Require?
The written mandate required under Art. 11(2) MDR must specify at minimum the tasks listed in Art. 11(3) MDR. Many manufacturers treat this as a pro forma document. This approach ignores that the mandate simultaneously serves three functions: regulatory compliance documentation, commercial services agreement, and liability allocation mechanism. Three functions. Three drafting approaches. They do not naturally harmonize.
Consider scope definition. The regulation requires the representative to verify that conformity assessment has been carried out appropriately. What does verification entail? A documentary check that certificates exist? Substantive review of the conformity assessment procedure? Independent assessment of technical documentation adequacy? The regulatory text permits any interpretation. MDCG 2022-16 on economic operator obligations provides some guidance on how competent authorities and notified bodies interpret this requirement in practice, and while MDCG guidance is non-binding, it represents the coordinated position of national competent authorities and is the standard against which compliance will be assessed during market surveillance and notified body audits.11MDCG 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) (October 2022). The contract must choose a verification standard, and the choice affects both the representative's service fee and the manufacturer's exposure if verification proves inadequate.
Termination provisions present particular difficulty. Art. 11(6) MDR requires an authorized representative who terminates the mandate due to manufacturer non-compliance under Art. 11(3)(h) MDR to immediately inform the competent authority and any involved notified body. Art. 12 MDR addresses change of authorized representative, including transition arrangements. But what triggers termination beyond clear regulatory breach? Commercial dispute? Insolvency of the manufacturer? The regulation contemplates notification for specific circumstances; it does not address the potentially contested factual questions about whether termination was valid and which party bears responsibility for regulatory consequences during any transition period.
The duration and renewal provisions present particular difficulty. Art. 11 MDR does not specify minimum mandate periods. A one-year mandate with automatic renewal may satisfy regulatory requirements but creates instability for manufacturers who have built EU market presence on that representative relationship. A five-year fixed-term mandate provides stability but limits the manufacturer's ability to respond to representative performance issues or commercial changes. What happens if the representative ceases business operations during the mandate period? The regulation contemplates notification to competent authorities; it does not address product recall obligations, documentation transfer, or transition to a successor representative during any gap period.
The question of exclusive versus non-exclusive representation also lacks regulatory guidance. A manufacturer may wish to engage one representative for all EU markets. The representative may prefer geographical or product category limitations. Neither preference is prohibited, but each creates different regulatory filing requirements and different liability concentration patterns.
If the authorized representative provides services to multiple manufacturers (a common commercial model), the question of whether one manufacturer's device defect could create reputational or operational spillover effects for other manufacturers using the same representative becomes relevant. A market surveillance authority investigating one manufacturer's device may request documentation that the representative holds for other mandates; a serious incident involving one product may trigger competent authority scrutiny of the representative's verification procedures across all mandates. The contractual structure must address information barriers, conflict procedures, and termination triggers that the regulation does not contemplate.
6. What Information and Coordination Duties Apply?
The authorized representative must keep available specified documentation for competent authority inspection: the EU declaration of conformity, technical documentation, and if applicable, a copy of relevant certificates including amendments and supplements. "Keep available" implies both physical or electronic accessibility and continuing accuracy. If the manufacturer updates technical documentation, what notice period applies before the representative must have the updated version available? What audit rights does the representative require to verify that documents provided by the manufacturer remain current?
Art. 15 MDR requires manufacturers to have within their organization a person responsible for regulatory compliance (PRRC) meeting specified qualification requirements.12Art. 15 MDR. The PRRC must possess the requisite expertise in the field of medical devices, demonstrated by specified qualifications or professional experience. For non-EU manufacturers, the PRRC may be located outside the Union, but the authorized representative's verification duties under Art. 11(3)(a) MDR must account for this arrangement. Whether the mandate agreement specifies how the authorized representative verifies that the manufacturer's PRRC meets the Art. 15 MDR requirements, and what consequences follow if qualification gaps are discovered post-mandate, are questions the regulatory framework leaves to the parties.
EUDAMED registration creates additional coordination requirements, but the practical scope of those requirements depends on which modules are actually operational.13Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards the European database on medical devices (EUDAMED) [2021] OJ L426/9. The actor registration, UDI/device registration, notified bodies and certificates, and market surveillance modules are operational on a voluntary basis; the Commission has not yet adopted the decision declaring them fully functional; the manufacturer retains primary registration responsibility, and the authorized representative must be identified in the registration and verify certain information. However, the post-market surveillance and vigilance module and the clinical investigations/performance studies module remained, as of early 2025, under development, and the full system was not yet mandatory for all functions the regulation contemplates. The coordination duties that depend on these non-operational modules (automated incident reporting, electronic field safety notices, cross-referencing of post-market surveillance data) exist on paper but cannot yet be fulfilled through the system itself. Mandate agreements that reference EUDAMED obligations without distinguishing between operational and anticipated modules risk creating contractual commitments that exceed what the system supports. A discrepancy between manufacturer-submitted data and representative-verified data in the operational modules creates a regulatory compliance gap. The mandate agreement must address data reconciliation procedures that the regulation assumes but does not specify.
Vigilance reporting adds another layer. The manufacturer bears primary reporting obligations for serious incidents and field safety corrective actions. The authorized representative may receive incident information from users or healthcare professionals before the manufacturer does. What constitutes adequate transmission? Immediate forwarding of raw data? Preliminary assessment before transmission? The regulatory requirement to inform "immediately" coexists uneasily with practical realities of cross-border communication and time-zone differences.
The liability question extends beyond product defects. Art. 11(3)(g) MDR requires the authorized representative to inform the manufacturer immediately of complaints and reports from healthcare professionals, patients, and users. A delay in transmission could constitute breach of regulatory obligation. Whether this regulatory breach creates civil liability between the parties, and under which substantive law, depends on how the mandate agreement characterizes the information transmission duty, as a best-efforts obligation or a strict compliance requirement with specified response windows.
The questions multiply. Does the representative's duty to verify documentation extend to independent technical assessment, or is documentary completeness sufficient? When the manufacturer and representative disagree on whether an incident requires reporting, whose assessment controls the regulatory timeline? And if competent authority inspections at the representative's premises reveal documentation gaps, how is responsibility allocated between parties who may blame each other for the gap?
7. What Strategic Factors Shape the Representative Relationship?
Swiss manufacturers selecting an authorized representative face choices that regulatory requirements frame but do not resolve. The decision involves regulatory competence, commercial terms, liability capacity, and operational fit. Template agreements available from industry associations address generic requirements. They do not address the specific risk profile of a particular manufacturer's product portfolio, regulatory history, or commercial relationships in the EU market.
The strategic analysis begins with whether the mandate agreement has been drafted as an integrated document serving regulatory, commercial, and liability functions, or whether gaps exist between these functions that create exposure during disputes.
Indemnification provisions must account for the practical enforceability of claims against a Swiss manufacturer from an EU-based representative's perspective. An indemnification clause that cannot be enforced (because the manufacturer lacks EU assets, has entered insolvency, or disputes the liability trigger) determines how risk actually distributes, regardless of what the contractual allocation says on paper.
The information coordination protocol requires testing against realistic scenarios involving time-sensitive regulatory obligations, not merely documentation of theoretical procedures. A complaint or incident notification that must be forwarded "immediately" under Art. 11(3)(g) MDR tests differently when the manufacturer is in a non-overlapping time zone than when it is a train ride away.
The termination framework must address regulatory consequences of disputed termination, including responsibility during transition periods when both parties may deny obligation. Under Art. 11(6) MDR, the representative's notification obligations to competent authorities and notified bodies survive the commercial relationship, creating a period where regulatory duties persist after contractual obligations have ended or are contested.
And if the manufacturer's product portfolio spans both MDR and IVDR, the representative structure warrants analysis for regulatory efficiency and liability concentration that single-regulation mandates do not require. A combined mandate may reduce coordination overhead but concentrates all EU regulatory exposure in a single entity; separate mandates distribute risk but multiply the contractual interfaces the manufacturer must manage.
The authorized representative relationship is simultaneously regulatory, commercial, and fiduciary, and tensions between these functions emerge unpredictably. Generic analysis cannot resolve them; only assessment tailored to specific product portfolios, representative capabilities, and EU market strategy can identify where the gaps lie.