Swiss authorised representatives for medical device manufacturers (CH-REP)

Medical device or IVD manufacturers and System or Procedure Pack producers based outside of Switzerland need a Swiss Authorised Representative (CH-REP) if they want to sell their devices on the Swiss market. Here is all you need to know about it.

Replaces version of 13.11.2023

The agreement facilitating trade of CE-marked products between the European Union (EU) and Switzerland, known as the Mutual Recognition Agreement (MRA), ceased to apply with the application of Regulation (EU) 2017/745 on medical devices (EU MDR) in May 2021, and Regulation (EU) 2017/746 on IVDs (IVDR) in May 2022.

Since then, manufacturers who are not based in Switzerland or Liechtenstein, require a Swiss Authorised Representative (in German: Schweizer Bevollmächtigter, and in French: mandataire suisse) to continue placing their CE-marked medical devices, IVDs, procedure packs and systems on the Swiss market. 

If you are not familiar with the role of and requirements for appointing a Swiss Authorised Representative (CH-REP) for foreign device manufacturers and procedure pack/system producers, read on. We also invite you to read about Decomplix’ Swiss Authorised Representative services.

Key Takeaways

• Any foreign manufacturer that places medical devices and IVDs on the Swiss market and any foreign assembler of systems or procedure packs must appoint a Swiss Authorised Representative (CH-REP).
• Individual medical devices and IVDs that are part of a system or procedure pack and are CE-marked by foreign manufacturers also need a CH-REP.
• Negotiations between Switzerland and the EU to reinstate the Mutual Recognition Agreement (MRA) are ongoing and might result in the CH-REP role becoming redundant, at the earliest in 2028.

Content

What is the MRA? What are the MedDO and the IvDO?

Importing CE-marked medical devices (incl. IVDs) into Switzerland used to be indistinguishable from importing them into any other EEA country, because the former European Directives 93/42/EEC concerning medical devices (MDD), 90/385/EEC on active implantable medical devices (AIMDD), and 98/79/EC on in vitro diagnostic medical devices (IVDD) were fully adopted under the former Swiss legislation, based on the Mutual Recognition Agreement (MRA) between Switzerland and the EU. 

This is no longer the case. 

The MRA ceased to apply on 26 May 2021 for medical devices and on 26 May 2022 for IVDs. Since then, Switzerland is considered a third country to the effects of the EU MDR (Reg. (EU) 2017/745) and IVDR (Reg. (EU) 2017/746). On the same date, Switzerland enacted a revised version of its Medical Device Ordinance (SR 812.213, MedDO) and a new In-vitro Diagnostics Device Ordinance (SR 812.219, IvDO), which introduced the requirement to appoint a Swiss Authorised Representative (CH-REP) for all:

• medical devices CE-marked by manufacturers established outside Switzerland [MedDO Art. 51(1)], or Liechtenstein. This applies also to “legacy” medical devices.
• custom-made devices from manufacturers established outside of Switzerland or Liechtenstein.
• “Annex XVI products” from manufacturers established outside of Switzerland or Liechtenstein.
• procedure packs and systems assembled by producers established outside Switzerland [MedDO Art. 51(5)], or Liechtenstein.
• IVDs CE-marked by manufacturers established outside Switzerland [IvDO Art. 44(1)], or Liechtenstein. This applies also to “legacy” IVDs.

Read more about legacy devices in Decomplix’ blog article “Legacy” medical devices and IVDs under EU legislation.

In order to revert the situation, Switzerland and the EU have initiated negotiations to reinstate the MRA, which entails the approval of a new package of bilateral agreements. The signed agreements and protocols are expected to land in the Swiss Parliament in the first quarter of 2026. It is highly likely that a referendum will be requested, which may result in the rejection of the deal.

If the agreements are approved, the MedDO and IvDO will have to be amended for full mutual recognition which will entail discontinuation of the CH-REP role. This full mutual recognition could be expected at the earliest in 2028.

The appointment of an authorised representative cannot happen overnight.

What is a Swiss Authorised Representative?

A Swiss Authorised Representative corresponds to:

“any natural or legal person established within Switzerland who has received a written mandate from a manufacturer located in another country to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligation under this Ordinance”. [MedDO Art. 4 §1(g) / IvDO Art. 4 §1(f)]

Upon acceptance of the written mandate, this natural or legal person based in Switzerland becomes the representative of the foreign manufacturer before the Swiss competent authority, Swissmedic, and is legally liable for defective devices, on the same basis and jointly and severally with the manufacturer. 

Swissmedic has clarified that, by virtue of the customs treaty with Liechtenstein, “established in Switzerland” means both Switzerland and Liechtenstein, provided the devices are placed on the market based on the MedDO/IvDO.

Moreover, per Article 51 §2 of the MedDO and Article 44 §2 of the IvDO, the Swiss Authorised Representative is responsible for the formal and safety-related aspects of placing a device on the Swiss market.

Is a Swiss Authorised Representative needed for all types of medical devices?

A Swiss Authorised Representative is required under the MedDO for:

• all medical devices, including custom-made devices and products without a medical purpose listed in Annex 1 of the MedDO,
• all Procedure Packs, as defined in Article 2(10) of the EU MDR, and
• all Systems, as defined in Article 2(11) of the EU MDR

that are being placed on the market in Switzerland, within the meaning of Article 4 §1(b) of the MedDO. 

In addition, a Swiss Authorised Representative is required for all in vitro diagnostic devices (IVDs) placed on the market in Switzerland, within the meaning of Article 4 §1(b) of the IvDO.

In theory, direct sales of medical devices and IVDs from foreign manufacturers to Swiss-based healthcare institutions who are the end users of the devices could be possible without designation of a Swiss Authorised Representative because this direct sale does not correspond to the definition of “placing on the market”. However, Swissmedic discourages such practices.
Chapter 7 of Swissmedic’s Information Sheet on Procurement of Medical Devices in Health Institutions indicates that “healthcare professionals and institutions should usually procure products from a Swiss manufacturer or that have a Swiss authorised representative and only directly use products from abroad without a Swiss authorised representative in justified exceptional cases”.

Note that the requirement to appoint a Swiss Authorised Representative applies equally to devices placed on the market in compliance with the new Regulations (i.e. EU MDR or IVDR) and to “legacy devices” that may remain on the market in compliance with the former MDD/AIMDD/IVDD, including Procedure Packs or Systems still covered under the MDD.

What are the duties of the Swiss Authorised Representative?

The duties of a Swiss Authorised Representative under the MedDO/IvDO are similar to those of a EU Authorised Representative under the EU MDR/IVDR. 

Article 51 §3 of the MedDO describing the Swiss Authorised Representative’s duties calls out Article 11 of the EU MDR and Article 44 §3 of the IvDO calls out Article 11 of the IVDR. Consequently, the Swiss Authorised Representative role for medical devices is analogous to that of the EU Authorised Representative. Similarly, per Article 51 §4 of the MedDO and Article 44 §5 of the IvDO, a change in Swiss Authorised Representative is governed by the same requirements as those for a change in EU Authorised Representative, per Article 12 of the EU MDR or IVDR, as applicable.

It is however important to highlight a significant difference between the role of EU Authorised Representative under the EU MDR/IVDR and that of Swiss Authorised Representative under the MedDO/IvDO: the Swiss Authorised Representative is “responsible for the formal and safety-related aspects of placing the device on the market”. Although there is no guidance that allows clarifying this addition with respect to the EU MDR/IVDR, the level of responsibility of the Swiss Authorised Representative appears to be higher than that of its EU counterpart.

The duties of a Swiss Authorised Representative under the MeDO/IvDO include:

• To verify that the Declaration of Conformity and technical documentation have been drawn up and, where applicable, that the manufacturer has carried out an appropriate conformity assessment procedure. This would include verifying that the device labeling fulfills the requirements of the MedDO/IvDO. In addition, for the verification of extended validity of EC Certificates for “legacy” devices under the MDD/AIMDD. Swissmedic’s expectation is for Swiss Authorised Representatives to check the plausibility of:
  • the manufacturer’s self-declaration under EU MDR Art. 120(3c), 
  • the Notified Body’s confirmation letter stating that the manufacturer has lodged an application for EU MDR certification.
• To keep available a copy of the technical documentation, the Declaration of Conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, at the disposal of the competent authority (Swissmedic) for the applicable retention period (10 or 15 years, depending on the type of device).
  As an alternative, per Article 51 §3bis of the MedDO and Article 44 §4 of the IvDO, instead of the Swiss Authorised Representative keeping a copy of the technical documentation, the manufacturer could submit the documentation directly to Swissmedic on request, in which case the Swiss Authorised Representative shall ensure that this happens within 7 days of Swissmedic’s request.

• To comply with the applicable Economic Operator registration obligations, which in Switzerland are provided for in Article 55 of the MedDO and Article 48 of the IvDO, whichever applies.
• Upon request from Swissmedic, to provide all the information and documentation necessary to demonstrate the conformity of a device, which might be required in the Swiss official languages (i.e. German, French, and Italian).
• To forward to the manufacturer any request from Swissmedic for either device samples or access to a device, and to verify that Swissmedic receives those samples or is given access to the device.
• To cooperate with Swissmedic on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by the medical devices.
• To immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
• To terminate the mandate if the manufacturer acts contrary to its obligations under the MedDO.

In addition, the Swiss Authorised Representative is responsible for ensuring the reporting to Swissmedic any:

• Serious incidents occurring in Switzerland, as soon as it becomes aware of them, as well as the corresponding final report with any investigation findings and indication of corrective actions taken,
• Field Safety Corrective Actions (FSCA) initiated in Switzerland, and
• Vigilance trend reports on incidents occurring in Switzerland and abroad.

This responsibility, which applies under the MedDO and IvDO alike, appears to be understood by Swissmedic as an oversight role, where the actual reporting can be undertaken by either the foreign manufacturer or the Swiss Authorised Representative. However, per Article 66 §2bis of the MedDO and Article 59 §3 of the IvDO, the Swiss Authorised Representative is expected to submit any final reports and the trend reports without being requested to do so, and such responsibility transfer from the manufacturer to the Swiss Authorised Representative must be agreed in writing in the mandate, which requires some means of control of the Swiss Authorised Representative over the manufacturer’s Vigilance process.
For more details on Swiss Vigilance requirements, please consult Swissmedic’s Vigilance webpage.

The level of responsibility of the Swiss Authorised Representative appears to be higher than that of its EU counterpart.

Like in the EU MDR/IVDR, certain manufacturer’s obligations cannot be delegated to the Swiss Authorised Representative either under the MedDO or the IvDO, namely:

• Ensuring the device conformity.
• Implementing a compliant risk management system.
• Performing clinical evaluations, including post-market clinical follow-up activities.
• Compiling or keeping up-to-date the device technical documentation.
• Drawing up the EU Declaration of Conformity.
• Assigning and maintaining device UDIs.
• Maintaining the manufacturer’s quality management system.
• Implementing the manufacturer’s post-market monitoring system.
• Preparing device labeling (i.e. on-device labels, packaging labels, and instructions for use, as applicable).
• Establishing any necessary corrective actions to bring any non-conforming device into conformity.

The Swiss Authorised Representative’s name and address must be indicated on the device labelling. However, exceptions apply. For details, see: Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?

Also, the Swiss Authorised Representative must register with Swissmedic in order to obtain a Swiss Registration Number (CHRN) for its economic operator role. This registration, required per Article 55 of the MedDO and Article 48 of the IvDO must be completed in the Swiss database on medical devices, swissdamed, within 3 months of the first placing devices on the Swiss market (or in Liechtenstein). Subsequent changes to the Swiss Authorised Representative’s information (e.g. change in address) must be uploaded in swissdamed within 1 week.

Last, as required under Article 52 of the MedDO and Article 45 of the IvDO, the Swiss Authorised Representative must have permanently and continuously at its disposal a Person Responsible for Regulatory Compliance. This role mirrors the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR/IVDR. However, contrary to the position expressed in guidance document MDCG 2019-7 relative to the PRRC role in EU, Swissmedic does not limit the geographic location of the Swiss Authorised Representative’s PRRC. As such, the Swiss Authorised Representative’s PRRC can be based in any country and can even correspond to the PRRC of the foreign manufacturer or of its EU Authorised Representative.

Read more about The role of a PRRC under the EU MDR & IVDR.  

What UDI registration requirements apply to the Swiss Authorised Representative under the MedDO and IvDO?

EUDAMED not being accessible to Swissmedic as the competent authority of a “third country” for the effects of the EU MDR and IVDR, the registration of UDI core data elements required by the EU MDR and IVDR are implemented in Switzerland via the country-specific database on medical devices (swissdamed). This database encompasses 2 modules: economic operator registration (Actors module) and device registration (UDI module).

While the registration of Swiss economic operators in swissdamed is required from August 2024, device registration in the UDI module shall be mandatory 6 months after the obligation to register devices in EUDAMED’s UDI module. Until then, a UDI registration in “voluntary” mode for EU MDR/IVDR devices is possible since August 2025.

To register device information, a company must be registered as an actor in swissdamed. And only Swiss-based economic operators can register as actors in swissdamed. Swiss Authorised Representatives may delegate the uploading of UDI data to the foreign manufacturers and Procedure Pack/System producers. In this scenario, however, Swiss Authorised Representatives remain responsible for data integrity.

Device registration in swissdamed involves downloading XML files from EUDAMED (or generating them using EUDAMED POST DEVICE format) and uploading them onto swissdamed. An infographic of the process is available from Swissmedic’s swissdamed Quick Guide on UDI registration.

For the time being, the only devices from foreign manufacturers that need to be notified to Swissmedic (via email, not swissdamed) are Custom-made devices (CMD), per MedDO Art. 19. Per Swissmedic’s FAQs on the notification of medical devices, the obligation to notify CMDs applies to either Swiss Authorised Representatives, Swiss importers or Swiss distributors before making CMDs available on the Swiss market. This requirement applies also to Swiss Authorised Representatives, importers or distributors based in Liechtenstein, when the devices are placed on the market according to the MedDO.

Decomplix offers CMD notification services. If you are interested, please contact us via this form.

Is the Swiss Authorised Representative also the Swiss Importer?

No, the Swiss Authorised Representative and the Swiss Importer are different economic operator roles with different regulatory duties under the MedDO and IvDO. 

The duties of the Swiss Importer for medical devices are governed by Article 53 of the MedDO and Article 46 of the IvDO. Even if these involve compliance verification and notification requirements, which could be considered akin to those applicable to the Swiss Authorised Representative, the obligations cover also warehousing and transportation activities, including the necessary quality management system. Whereas a Swiss Importer could take on the additional role of Swiss Authorised Representative, provided it had sufficient in-house regulatory resources, the opposite is rarely the case since importation entails, in addition to regulatory compliance with the MedDO/IvDO, customs clearance, logistic, and tax-related activities and companies offering Swiss Authorised Representative services tend to be regulatory consultancy companies without competence in those domains. 

The role of a Swiss Importer is naturally easier for an existing Swiss distributor. It is also important to note that Swissmedic, in its Information Sheet on the Obligation of Economic Operators, considers an entity to be the Swiss Importer “by action” (i.e. any entity who places a medical device on the Swiss market) as opposed to “by designation”.

The duties of a Swiss Importer under the MedDO/IvDO are similar to those of the EU importer under the EU MDR/IVDR. Like the Swiss Authorised Representative, the Swiss Importer shall register with Swissmedic within 3 months of its placing of devices (MDR/IVDR compliant or “legacy” devices) on the Swiss market for the first time after the date of implementation of the MedDO/IvDO.

The role of a Swiss Importer is naturally easier for an existing Swiss distributor.

Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?

The MedDO and IvDO do not explicitly require that the Swiss Authorised Representative’s particulars appear on the device labelling. 

Now, Article 6 §2 of the MedDO and of the IvDO requires that all medical devices placed on the Swiss market comply with the General Safety & Performance Requirements (GSPR) in Annex I of the EU MDR/IVDR, which in turn require that the product label bears the name and address of the EU Authorised Representative. This applies by analogy, specifically because MedDO Annex 2 and IvDO Annex 1 list the correspondence of terms between the EU regulation and Swiss ordinance. Amongst them, “Union” would correspond to “Switzerland”. Therefore, GSPR #23.2(d) in the EU MDR and GSPR #20.2(d) in the IVDR should be “translated” to the effects of MedDO/IvDO into: “if the manufacturer has its registered place of business outside Switzerland, the name of the authorised representative and address of the registered place of business of the authorised representative.“

As to “legacy devices”, per Article 101 of the MedDO and Article 82 of the IvDO, they can remain on the Swiss market, provided they continue to comply with the requirements of the MDD/AIMDD or IVDD, as applicable. And the Essential Requirements (ER) in Annex I of the MDD/IVDD or Annex 1 of the AIMDD also call for the authorised representative’s name and address to be mentioned on the device labelling.

The indication of the Swiss Authorised Representative’s particulars is required from the day of application of the MedDO/IvDO but some exceptions or grace periods were granted by Swissmedic. The currently applicable requirements are summarized in its Information Sheet on the Obligations of Economic Operators, as follows:

(*) Swissmedic considers that the “document accompanying the device” may be attached to or separate from the device. It does not therefore necessarily have to reach the end user. The purpose of the information is a quick and clear identification of the economic operators responsible for the devices at hand, e.g. for the implementation of product recalls, for the reporting of incidents, for notifications of dangerous products or non-conformities and in the context of enforcement.
Examples of documents accompanying the device: delivery note, warranty certificate, customs documents, invoice, a sticker on the packaging or instructions for use.

Note that the Swiss Authorised Representative’s labelling requirement applies to any device unit placed on the Swiss market, not for a device model. As such, it is required for new devices as well as for refurbished devices that are assigned a new serial number or UDI-PI.

In the cases where the Swiss Authorised Representative’s particulars must appear on the device labelling, Decomplix considers that a permanent sticker with the Swiss Authorised Representative’s particulars would suffice, and the sticker should be affixed to the existing packaging element that requires such labelling. The over-labelling could be undertaken by the Swiss importer.

When required on the labelling, the Swiss Authorised Representative’s particulars must be preceded by either the new symbol below or any of the following texts: “CH authorised representative” / “Authorised representative for Switzerland” / “CH-REP”.

The new Swiss Authorised Representative (CH-REP) symbol.

According to Article 16 §2 of the MedDO and Article 15 §2 of the IvDO relative to language requirements that apply to labelling, the first two texts would require translation in German, French and Italian. Conversely, the use of the “CH-REP” symbol or text would not. As to the actual address, according to Swissmedic’s explanation on its CH-REP webpage, the main requirement is that the address “must enable contact to be established”. Decomplix considers that it is not necessary to translate the city in the Swiss Authorised Representative’s address into other Swiss languages as addresses within Switzerland are driven by the postal code.

Also, from Swissmedic’s perspective, it is acceptable not to explain the meaning of this Swiss-specific CH-REP symbol in the instructions for use.

What happens with Procedure Packs and Systems?

Assemblers of medical device kits that correspond to the definition of Procedure Packs, per Article 2(10) of the EU MDR, or Systems, per Article 2(11) of the EU MDR, also need to appoint a Swiss Authorised Representative, per Article 51 §5 of the MedDO. This might come as a surprise to non-EEA Procedure Pack or System producers because there is no similar requirement at the EU level.

Swissmedic’s Information Sheet on Procedure Packs and Systems clarifies that a Swiss Authorised Representative must be mandated for every individual medical device or IVD from a foreign manufacturer that is part of a System or Procedure Pack. It is also important to note that the particulars of the Swiss Authorised Representative must appear on the label or the IFU even for “legacy” Systems or Procedure Packs.

Procedure Packs and Systems from foreign assemblers also need a Swiss Authorised Representative.

How is other EU legislation that might be relevant for medical devices affected by the MRA?

Similar to the situation of medical devices and IVDs,  as long as the EU legal act in the scope of Annex 1 of the MRA does not change, the mutual recognition remains valid because the MRA has not been withdrawn.

Annex 1 of the MRA covers the following product sectors:

As long as the EU legal act in the scope of Annex 1 of the MRA does not change, the mutual recognition remains valid.

Out of these, some might apply to medical devices beyond Chapter 4, e.g. machinery, personal protective equipment, radio equipment, equipment for use in potentially explosive atmospheres, and it is important for foreign manufacturers to monitor any upcoming changes that might entail the repeal of the existing EU legislative acts. The next one to be affected might be the Machinery Directive (i.e. Dir. 2002/46/EC), which shall be replaced by the new Regulation (EU) 2023/1230 in January 2027. If by then the MRA is not reinstated, Swiss Authorised Representatives will also be required under this new regulation.

What actions do foreign manufacturers need to take on the Swiss market?

The appointment of the Swiss Authorised Representative does not happen overnight. Even once the manufacturer has identified the most convenient entity in Switzerland, the designation process entails, at a minimum:

• Swiss Authorised Representative mandate review and, where necessary, negotiation of the related contractual clauses. This might be very time-consuming, particularly for EEA-based manufacturers who are not familiar with the requirements of a EU Authorised Representative and for foreign manufacturers who have not read the MedDO/IvDO.
• Setting up internal procedures in the foreign manufacturer’s Quality Management System to describe, for example the communication processes, the Swiss-specific Vigilance requirements, the labelling requirements, and the availability of the Technical Documentation in English or a Swiss national language within 7 days of a Swissmedic’s request.
• Agreeing on the logistics to ensure the most suitable means of sharing information and documents.
• Undergoing the initial verification of compliance by the Swiss Authorised Representative, which might result in a rejection of the Swiss Authorised Representative mandate, which is a legal obligation under Article 11(3)(h) of both the EU MDR and IVDR. Such a rejection would imply that the foreign manufacturer would have to seek another Swiss Authorised Representative and start the process over, without guarantee of a more successful outcome.
• Implementing the Swiss Authorised Representative’s particulars on the device labelling or on accompanying documents, as required.

Note that a foreign manufacturer may appoint more than one Swiss Authorised Representative to cover its portfolio intended to be sold in Switzerland, which might make sense for big corporations with independent divisions. However, the designation of each Swiss Authorised Representative must be effective at least for all devices of the same generic device group sold in Switzerland.

How can Decomplix help?

Decomplix offers Swiss Authorised Representative services  since May 2021, is duly registered with Swissmedic, and already represents numerous foreign manufacturers of different sizes all over the world.
Our services include instructions and checklists for your understanding of the applicable requirements. 

If you are interested in Decomplix’ Swiss Authorised Representative services, please contact us via this form and send us the relevant data mentioned there.

Further reading

• Regulatory guide to Procedure Packs, Systems, IVD Kits, and Configurable devices
• Swiss medical device importers – regulatory requirements
• Is my product a medical device in Europe? How to determine if your product requires medical device CE marking
• Requirements for medical device and IVD distributors in the EU
• “Legacy” medical devices and IVDs under EU legislation

This article has been updated with information on the upcoming swissdamed’s UDI module, Swissmedic’s position on CH-REPs for Procedure Packs and Systems, as well as with the latest information on the negotiations between Switzerland and the EU to reinstate the Mutual Recognition Agreement (MRA).