Assume, for illustration, that a US device manufacturer signs a Swiss distribution agreement and accepts an affiliated company’s offer to act as its local representative. Commercial responsibility appears settled. Yet the mandate determines who can obtain a changing technical file, who answers Swissmedic when a safety issue emerges, and whose name remains on products after the relationship ends. Those responsibilities can diverge from the distribution contract, while the representative’s statutory liability reaches beyond the parties’ allocation of their own losses.
1. What does the written CH-REP mandate actually transfer?
For a US manufacturer placing devices on the Swiss market, Art. 51(1) MepV and Art. 44(1) IvDV require appointment of a representative established in Switzerland before the devices are placed on that market. Both provisions require a written mandate. The representative handles formal and safety matters associated with placing the device on the market, but the statutory description does not make every obligation negotiable. A contract that describes the appointment as administrative support can understate what the appointment entails.1Medizinprodukteverordnung (MepV) vom 1. Juli 2020 (SR 812.213), Art. 4(1)(g) and Art. 51; Verordnung über In-vitro-Diagnostika (IvDV) vom 4. Mai 2022 (SR 812.219), Art. 4(1)(f) and Art. 44.
The link to EU law is unusually direct. Through Art. 51(3) MepV and Art. 44(3) IvDV, the mandate’s scope and the representative’s rights and duties follow Art. 11 MDR and Art. 11 IVDR, respectively. Those provisions require written acceptance and coverage of at least all devices within the same generic device group. Their minimum tasks include checking that conformity documents exist, making documents available to authorities, cooperating on corrective action and forwarding suspected-incident complaints. They also prohibit delegation of specified core manufacturer obligations. An appointment can create an additional responsible participant without relieving the manufacturer of the underlying manufacturing and compliance duties.2Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices [2017] OJ L117/1 (MDR), Art. 11(2)–(4); 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), Art. 11(2)–(4).
The familiar US-agent comparison reaches only part of the relationship. Under 21 C.F.R. § 807.40(b)(2), the agent assists the FDA with communications, product questions and inspection scheduling. Identification of importers is addressed separately in 21 C.F.R. § 807.41. That communication role offers a poor basis for assuming that a Swiss representative merely receives correspondence. Equally, a customs reference to an importer of record cannot determine which participant carries the separate device-law responsibilities in Switzerland.321 C.F.R. § 807.40(b)(2), § 807.41 (2025).
The distinction becomes material when a Swiss distributor offers to perform both roles. Swissmedic’s Obligations Economic Operators CH, version 7.0 of 1 May 2026, distinguishes a representative appointed through a mandate from an importer whose role follows the activity performed. One entity can carry both sets of duties. Combining them may put commercial control of stock and the safety relationship in the same hands, but an exclusive distribution agreement does not alone establish the scope of the regulatory appointment. For devices placed on the market under the MepV or IvDV, Swissmedic treats Switzerland and Liechtenstein as a common market and explains that a manufacturer in Liechtenstein need not appoint a Swiss representative; that qualification does not extend to devices placed on the Liechtenstein market under the MDR or IVDR alone.4Swissmedic, Obligations Economic Operators CH (Information sheet MU600_00_016, version 7.0, 1 May 2026), sections 1.2, 3, 5 and 6.
The historical background does not eliminate those distinctions. The Commission’s notices identify 26 May 2021 for the loss of the relevant trade-facilitating effects for MDR devices and 26 May 2022 for in vitro diagnostics under the MRA. They do not describe the entire Swiss-EU agreement as terminated. The resulting separation of representative roles is addressed in the analysis of Swiss MedTech trade without mutual recognition; the contractual question here concerns the duties attached to the Swiss appointment itself.5European Commission, Notice to Stakeholders: Status of the EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices (26 May 2021), 1–2.
A mandate covering a named product portfolio can therefore become contentious when the portfolio changes. A hypothetical manufacturer may regard a revised diagnostic platform as covered by an existing commercial agreement while the representative sees a different regulatory assignment. The generic-device-group rule does not turn a sales catalog into an agreed mandate. Which devices the representative accepted, which documents accompany them and which participant controls that record can affect the same dispute in different ways.
A Swiss representative can remain responsible to the authority and an injured person even where the manufacturer controls the evidence, the safety decision and the funds promised under their contract.
2. Who controls the documents when an incident arrives?
A technical file held abroad can appear to be a matter of convenience until Swissmedic requests it. Art. 51(3bis) MepV and Art. 44(4) IvDV allow the parties to agree that the manufacturer will send the technical documentation directly to Swissmedic instead of the representative keeping a copy. The representative must ensure delivery to Swissmedic within seven days. That alternative concerns the technical-documentation copy; it is not a general release from the conformity-document, verification and cooperation obligations incorporated through Art. 11 MDR and Art. 11 IVDR. A promise that the manufacturer will remain the sole custodian leaves the representative dependent on performance it must be able to secure.6MepV (n 1), Art. 51(3bis); IvDV (n 1), Art. 44(4).
The distinction matters for documents that change after market entry. Access to a file on the appointment date does not establish access to a later safety assessment, a revised declaration or a certificate supplement. An assurance that materials are available on request may coexist with restrictions imposed by a manufacturing partner or a document platform controlled elsewhere in the group. Confidentiality protections and intellectual property rights can explain that restriction commercially. They do not answer whether the representative can perform its statutory task when a complete version is required.
The incident-reporting duty makes that dependence sharper. Art. 66(2bis) MepV and Art. 59(3) IvDV make the required representative responsible for the specified reporting to Swissmedic, and require the transfer of those duties to be recorded in the written mandate. The provisions also address unsolicited trend reports concerning Swiss and foreign incidents and the relevant final reports. They reach beyond passing a local complaint to the manufacturer. A contract assigning all safety communications to the manufacturer does not remove the responsibility imposed on the representative by those Swiss provisions.7MepV (n 1), Art. 66(1)–(2bis); IvDV (n 1), Art. 59(1)–(3).
That allocation can collide with a global safety process. In a hypothetical group, the US quality team may hold the investigation file while an EU affiliate decides whether a field action is warranted and the Swiss distributor receives the customer’s report. The contract may contemplate a single approved corporate message. The representative nevertheless remains responsible for the Swiss reporting assigned to it. Disagreement over the completeness of the facts, or over who can authorize a submission, can therefore become a regulatory problem before the parties resolve their disagreement over contractual performance.
The person responsible for regulatory compliance introduces a further relationship. Art. 52 MepV and Art. 45 IvDV require the representative to have permanent and continuous access to at least one appropriately qualified person, commonly called the PRRC. The incorporated provisions also address substitution and written divisions of responsibility where several people share the role. The representative is the appointed economic operator; the PRRC is the qualified person available to it. Naming the latter in a contract does not make that person a substitute for the former’s obligations.8MepV (n 1), Art. 49(2)–(4) and Art. 52; IvDV (n 1), Art. 42(2)–(4) and Art. 45.
The question is consequently wider than whether a provider has a qualified name available. The manufacturer’s access restrictions, the representative’s right to request information and the compliance person’s actual ability to use that information may not coincide. A change of personnel can leave the agreement’s promised support intact on paper while altering the relationship through which a safety question is assessed. The seven-day documentation alternative and the reporting responsibility make that disconnect commercially significant: the representative may remain answerable while the information needed to act sits outside its organization.
An agreement can describe channels, authority and escalation, but a description cannot prove that those channels operate across time zones, affiliates and third-party document owners. Nor does unrestricted file access itself establish that the file is adequate. The mandate’s performance depends on both access and substance, while the parties’ confidentiality and quality agreements may divide them between different entities.
3. Can indemnity and insurance contain the representative’s liability?
Art. 47d(2) HMG makes the authorized representative jointly and severally liable with the manufacturer toward the injured person. Art. 47d(1) HMG requires the manufacturer or representative to have sufficient financial coverage for damage caused by defective devices. The statutory relationship to the injured person is different from a manufacturer’s promise to reimburse the representative. A contractual cap between those parties does not, by itself, replace the statutory liability with the cap.9Bundesgesetz über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG) vom 15. Dezember 2000 (SR 812.21), Art. 47d.
The EU wording can obscure that distinction in a multinational template. Art. 11(5) MDR and Art. 11(5) IVDR expressly address the case in which a manufacturer outside a Member State has not complied with the obligations in Art. 10 MDR and Art. 10 IVDR, respectively. Art. 47d(2) HMG does not express that manufacturer-noncompliance condition. Importing the EU sentence into a Swiss mandate as though it exhaustively described Swiss liability would therefore introduce a qualification absent from the Swiss statutory text. The precise claim still depends on the defective device, the alleged damage and the applicable liability rules.10MDR (n 2), Art. 11(5); IVDR (n 2), Art. 11(5); HMG (n 9), Art. 47d(2).
An indemnity has a separate economic function. Assume, for illustration, that the manufacturer agrees to reimburse the representative for a covered patient claim but the contract excludes amounts arising from the representative’s own breach. A single incident may produce allegations about both the device and a delayed Swiss report. The existence of a reimbursement promise does not resolve how those allegations divide the loss, who controls the defense, or whether the manufacturer has funds available when reimbursement is due. Those are contract-specific questions, rather than exceptions written into the injured person’s statutory claim.
Insurance creates a related distinction between a legal obligation to maintain financial coverage and the terms of a particular policy. Art. 47d HMG does not establish that every policy offered to a representative covers every device, territory, claimant or period implicated by its mandate. Equally, a certificate of insurance does not establish the meaning of exclusions or the relationship between the representative’s cover and the manufacturer’s cover. The allocation may be disputed when product liability, reporting failures and contractual reimbursement obligations arise from the same facts.
Administrative action follows another route. Under Art. 66 HMG, the competent authorities can take necessary measures within their powers, including specified restrictions and recalls. An agreement about who ultimately pays the representative does not itself constrain Swissmedic’s statutory powers. A dispute can therefore involve the injured person’s claim, the authority’s measures and the parties’ reimbursement rights simultaneously, with a different legal basis for each.11HMG (n 9), Art. 66(1) and (2)(d)–(e).
The manufacturer also has an interest in the representative’s continued ability to perform. If the parties disagree about an indemnity during an incident, the conflict may affect cooperation precisely when documents and reports are needed. Conversely, a broad indemnity can leave the manufacturer funding conduct over which it has limited practical control. Neither a high contractual cap nor a broad reimbursement clause establishes that the commercial allocation matches the authority, information and financial resources available to each participant.
4. What survives a switch of representative?
A change of representative does not end at the date of a termination notice. Art. 51(4) MepV and Art. 44(5) IvDV refer to Art. 12 MDR and Art. 12 IVDR for the change arrangements. The agreement involves the manufacturer, the incoming representative and, where practicable, the outgoing representative. Its required subjects include the end and start dates, the date until which the outgoing name may appear in manufacturer information, document transfer with confidentiality and property rights, and forwarding of suspected-incident complaints after the mandate ends. Commercial termination and regulatory succession consequently have overlapping but different content.12MepV (n 1), Art. 51(4); IvDV (n 1), Art. 44(5); MDR (n 2), Art. 12; IVDR (n 2), Art. 12.
The continued appearance of the outgoing name can be especially sensitive where stock remains with several importers. The manufacturer may regard a relabeling date as a production issue. The outgoing representative may see its name on products it no longer receives information about, while the incoming representative receives complaints relating to earlier supplies. Art. 12 MDR and Art. 12 IVDR require the transition agreement to address the date and the forwarding relationship. They do not make all historical stock, document rights and patient communications disappear on the appointment of a successor.
The permitted location of the Swiss representative’s details also depends on the device regime. Art. 16(1) MepV connects the product information to Annex I section 23.2(d) MDR; Art. 15(1) IvDV connects it to Annex I section 20.2(d) IVDR. Under Art. 15(9) IvDV, the specified details may appear in an accompanying document for non-self-testing products outside the legacy routes identified there. Swissmedic’s version 7.0 information sheet distinguishes that position from self-testing IVDs and from the different legacy-device configurations. A uniform instruction to change every carton, or to change only a delivery document, can therefore miss the applicable distinction.13MepV (n 1), Art. 16(1); MDR (n 2), Annex I section 23.2(d); IvDV (n 1), Art. 15(1) and (9); IVDR (n 2), Annex I section 20.2(d).
The historical appointment periods do not supply a new grace period for that switch. Art. 104a MepV set class-dependent appointment dates ending in 2021 or 2022 for the specified EU/EEA-linked manufacturers, and Art. 86 IvDV set the corresponding IVD appointment dates ending in 2022 or 2023. The former labeling transition in Art. 87 IvDV was repealed with effect from 1 January 2025. Those dates describe distinct historical arrangements. They cannot be treated as interchangeable permission to retain an outgoing representative’s name during a later contractual transition.14MepV (n 1), Art. 104a; IvDV (n 1), Art. 86 and Art. 87.
The CHRN creates a further distinction between identifying an actor and establishing that its products meet the law. Art. 55 MepV and Art. 48 IvDV, in their versions effective on 1 July 2026, require the relevant actor information before first placing a device on the market and changes within one week. Swissmedic checks the information and assigns the number. Its information sheet explains that an entity acting as both representative and importer receives two CHRNs. One registration does not merge the roles, and a change of representative does not by itself transfer the importer’s separate duties under Art. 53–54 MepV or Art. 46–47 IvDV.15MepV (n 1), Art. 53–55; IvDV (n 1), Art. 46–48.
The contrast with a negotiated exit becomes sharper if the manufacturer is noncompliant. Art. 11(3)(h) MDR and Art. 11(3)(h) IVDR require termination on that ground, with the associated notifications under Art. 11(6) of each regulation. A commercial notice provision cannot displace that duty. Whether a contested file or safety response constitutes noncompliance, and what the successor is actually accepting, may remain disputed at the point when commercial continuity matters most.16MDR (n 2), Art. 11(3)(h) and (6); IVDR (n 2), Art. 11(3)(h) and (6).
The analysis of the separate IVDR and Swiss IvDV transition rules addresses the device-transition background. A representative change adds its own questions about records, accepted scope and responsibility for devices already supplied. The original mandate can leave consequences after its commercial purpose has ended.
5. Strategic Considerations for Foreign Device Manufacturers
The mandate brings together obligations that operate on different terms. The manufacturer controls design and much of the evidence. The representative accepts duties to Swissmedic and a statutory position toward injured persons. The importer controls a separate part of the supply relationship. A contract can describe cooperation among them without establishing that the same entity controls the information, the response and the funds needed when a claim arises.
Which product groups and historical supplies did the representative actually accept, and does that understanding match the documents available to a successor? If the manufacturer retains the technical file, what restrictions in its supplier relationships could prevent timely delivery to Swissmedic? Where an incident involves both a product defect and a disputed reporting response, how do the particular indemnity and insurance terms divide a loss that the statute addresses differently? And when a commercial relationship ends during a safety investigation, which participant can still obtain the records and receive the complaints associated with the outgoing name?
Those questions turn on the particular portfolio, its document ownership and the relationships behind the appointment. The written mandate, the quality arrangements and the succession agreement may describe different versions of the same responsibility. Their interaction becomes visible when the representative must act while the parties disagree.