Swiss authorised representatives for medical device manufacturers

Have you heard about Swiss Authorised Representatives for medical device manufacturers? If you are not familiar with the role and requirements of the appointment of a Swiss Authorised Representative for foreign medical device manufacturers, read on.

Replaces any previous versions before 10.09.2021

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 for medical devices on 26 May 2021, date of application of the new Regulation (EU) 2017/745 on medical devices (EU MDR). As a result, Switzerland is now considered a third country to the effects of the EU MDR. On the same date, Switzerland enacted a revised version of its Medical Device Ordinance, SR 812.213 (MedDO), adapted to the new situation. Amongst the new requirements in this revised MedDO, medical device manufacturers who are not based in Switzerland, which now includes those based in EEA countries and those having a EU Authorised Representative in a EEA country, require a Swiss Authorised Representative (in German: Schweizer Bevollmächtigter, and in French: mandataire suisse) to continue placing their CE-marked medical devices on the market in Switzerland. 

You can also find answers to frequently asked questions that we are currently receiving from various quarters, as Decomplix provides Swiss Authorised Representative services.

Content:

What has happened with medical devices in Switzerland? What is the MRA? What is the MedDO?

Similar to the situation in the United Kingdom after BREXIT, the requirements for non-Swiss manufacturers of CE-marked medical devices got a little more complicated after 26 May 2021.

Importing CE-marked medical devices 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) and 90/385/EEC on active implantable medical devices (AIMDD) were fully adopted under the former Swiss Medical Device Ordinance (MedDO, SR 812.213), based on the Mutual Recognition Agreement (MRA) between Switzerland and the EU. This is no longer the case. 

As communicated in the Notice to Stakeholders issued by the EU Commission, the MRA ceased to apply for medical devices on 26 May 2021, date of application of the new Regulation (EU) 2017/745 on medical devices (EU MDR). As a result, Switzerland is now considered a third country to the effects of the EU MDR. On the same date, Switzerland enacted a revised version of its Medical Device Ordinance, SR 812.213 (MedDO), which has introduced additional requirements to account for the absence of an updated MRA. Per Article 51 of this revised MedDO, medical device manufacturers established in EEA countries, or established elsewhere and represented by EU Authorised Representative located in a EEA country, now need a Swiss Authorised Representative to sell their CE-marked devices in Switzerland, just like medical device manufacturers from outside the Union market. 

Furthermore, because the new EU MDR has repealed the former MDD and AIMDD, the existing MRA covering medical devices (including active implantable medical devices) is obsolete, and a Swiss Authorised Representative is required both for medical devices CE marked under the new EU MDR and for so-called “legacy devices”. Legacy devices are those that have been CE marked under the previous Directives (MDD or AIMDD) and benefit from the transitional provisions in Article 120 of the EU MDR.

In order to revert the situation, the MRA would need to be updated, which is unlikely to happen anytime soon as the EU Commission will not negotiate or update the MRA until an agreement between both parties has been established. Switzerland’s decision to not sign and to stop the process of the institutional agreement (InstA) unilaterally, has wide-ranging and long-term consequences. The current political situation in Switzerland makes it thus highly unlikely that there will be a solution  in the foreseeable future.

Without an updated MRA, Switzerland will remain as a “third country” to the effects of the EU MDR, and EEA countries will remain as “third countries” under the Swiss legislation on medical devices. 

Decomplix_224.dng

The appointment of an authorised representative cannot happen overnight.

What is a Swiss Authorised Representative?

Per the definition in Article 4 §1(g) of the Swiss MedDO, a Swiss Authorised Representative for a foreign medical device manufacturer 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”.

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. Moreover, per Article 51 §2 of the Swiss MedDO, 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?

The 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, but excluding in-vitro diagnostic medical devices, which are not concerned by the MedDO (see also What happens with in-vitro diagnostic medical devices (IVD)?),
  • 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 Swiss market, within the meaning of Article 4 §1(b) of the MedDO. Note that the requirement applies equally to devices placed on the market in compliance with the EU MDR and to “legacy devices” that may remain on the market in compliance with the former MDD/AIMDD, including Procedure Packs or Systems still covered under the MDD.

What are the duties of the Swiss Authorised Representative?

Article 51 §3 of the MedDO describing the Swiss Authorised Representative’s duties calls out Article 11 of the EU MDR on EU Authorised Representative. Consequently, the Swiss Authorised Representative role for medical devices is analogous to that of the EU Authorised Representative under the EU MDR. Similarly, per Article 51 §4 of the MedDO, 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.

It is however important to highlight a significant difference between the role of EU Authorised Representative under the EU MDR and that of Swiss Authorised Representative under the MedDO: as previously indicated, according to Article 51 §2 of the MedDO, 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 yet that allows clarifying this difference, the level of responsibility of the Swiss Authorised Representative appears to be higher than that of its EU counterpart.

Pursuant to Article 51 §3 of the MedDO, respectively Article 11 of the EU MDR, the duties of a Swiss Authorised Representative 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 labelling fulfils the requirements of the MedDO.
  • 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, 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.
  • 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, Article 66 §2bis of the MedDO requires that the Swiss Authorised Representative be 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.

This responsibility 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. (For more details, please consult Swissmedic’s Vigilance webpage.)

Also, per Article 55 §1 of the MedDO, the Swiss Authorised Representative needs to register for its economic operator role with Swissmedic and its initial registration must be completed at the latest 3 months after the first placing of devices on the Swiss market, which involves obtaining a Swiss Registration Number (CHRN) from Swissmedic. Any subsequent changes to the SAR information notified to Swissmedic (e.g. additional SAR mandates) shall be submitted by the SAR within 1 week. (For more information on timelines, see also When do foreign manufacturers need to take action?)

There are certain manufacturer’s obligations that could not be delegated to the Swiss Authorised Representative, 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.

Because Article 6 §1 of the MedDO requires compliance with the General Safety and Performance Requirements (GSPR) in Annex I of the EU MDR, and GSPR # 23.2(d) requires that the particulars of the EU Authorised Representative be indicated on the device label, the Swiss Authorised Representative’s name and address must appear on the device labelling. (See also Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?)

Last, as required under Article 52 of the MedDO, 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.

You can find more about the role of a PRRC under the MDR in this blog.

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

EUDAMED not being accessible to Swissmedic as the competent authority of a “third country” for the effects of the EU MDR, the registration of UDI core data elements required under Article 29 of the EU MDR will be implemented in Switzerland via the country-specific medical device information system, according to Article 62c of the Swiss Therapeutic Product Act (TPA, SR 812.21). This system is still under development. The details of such registration will be governed per the yet-to-be-enacted Article 17 §5 in the MedDO. This article had been included in a preliminary draft of the MedDO but was replaced in the final version by “to be enacted at a later stage” because it referred to EUDAMED. At this stage, it is not known when and how the Swiss medical device information system will be implemented.

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.

The duties of the Swiss Importer for medical devices are governed by Article 53 of the MedDO and, although they 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, 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 per Article 53 of the MedDO are similar to those of the EU importer under the EU MDR. Like the Swiss Authorised Representative, the Swiss Importer shall register with Swissmedic within 3 months of its placing of devices (MDR compliant or “legacy” devices) on the Swiss market for the first time after 26-May-2021, per MedDO Article 55 §1.

In addition, per Article 53 §2 of the MedDO, the Swiss importer’s particulars must appear on the device, its packaging or an accompanying document (which can be the shipping documents). (See also Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?)

DCX

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 does not explicitly require that the Swiss Authorised Representative’s particulars appear on the device labelling. 

Now, Article 6 §2 of the MedDO 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, and GSPR # 23.2(d) requires that the product label bears the name and address of the EU Authorised Representative. This applies by analogy, specifically because MedDO Annex 2 lists the correspondence of terms between the EU MDR and the MedDO. Amongst them, “Union” would correspond to “Switzerland”. Therefore, GSPR #23.2(d) should be “translated” to the effects of MedDO 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, they can remain on the Swiss market (if they are subject to a valid EC certificate or if they are Class I devices that should be upgraded to a higher class under the EU MDR) provided they continue to comply with the requirements of the MDD/AIMDD. And the Essential Requirements (ER) in Annex I of the MDD or Annex 1 of the AIMDD also call for the authorised representative’s name and address to be mentioned on the device labelling.

Swissmedic has taken a definite position regarding labelling requirements in version 2 of its Information Sheet on the Obligations of Economic Operators, published on 31-Dec-2021, as follows:

Type of device Economic Operator Labelling requirement
EU MDR compliant
Class I devices
CH-REP Until 31-Jul-2023: either on the label or on a document accompanying the device. (*)
After 31-Jul-2023: On the label.
Swiss Importer On the device or on the packaging or on a document accompanying the device. (*)
EU MDR compliant
Class IIa, IIb & III devices
CH-REP On the label
Swiss Importer On the device or on the packaging or on a document accompanying the device.(*)
MDD/AIMDD compliant devices that have a EEA-based legal manufacturer or EC-REP CH-REP MDD: On the label or in the instructions for use or on a document accompanying the device. (*)
AIMDD: On the commercial packaging and in the instructions for use or on a document accompanying the device. (*)
Swiss Importer On the device or on the packaging or on a document accompanying the device. (*)
MDD/AIMDD compliant devices that do not have a EEA-based legal manufacturer or EC-REP CH-REP MDD: On the label or instructions for use.
AIMDD: On the sales packaging and instructions for use.
Swiss Importer Recommended from 26-May-2021 and required from 31-Jul-2022:
On the device or on the packaging or on a document accompanying the device. (*)

(*) 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 (Swiss importer and, if applicable, CH-REP), 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.

Now, from the information provided by Swissmedic during its online event on 2-Sep-2021, the labelling of “legacy device” units that had been imported into Switzerland prior to 26-May-2021 and might still be in the Swiss importer warehouse do not need to be retrospectively amended to include the Swiss Authorised Representative’s particulars. Such units are considered to have been placed on the market in EU context according to the former legislative provisions.

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 (see above the differences for EU MDR compliant devices). 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 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 Authorized 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 in-vitro diagnostic medical devices (IVD)?

Because the MRA has not been withdrawn (it has just not been updated on the chapter about medical devices), EU Directive 98/79/EC on in-vitro diagnostic medical devices (IVDD) remains mutually recognized. Per the footnote on page 1 of the Notice to Stakeholders issued by the EU Commission on 26-May-2021:

“It is noted that the medical devices chapter of the EU-Switzerland MRA also covers trade of in-vitro diagnostic medical devices, based on the Directive 98/79/EC and the corresponding Swiss legislation. This part of the chapter continues to apply until the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices.”

The MedDO does not apply to in-vitro medical devices (IVD), with the exception of Articles 105 and 107. Specifically, Article 105 of the MedDO indicates that, until the new Swiss In-Vitro Diagnostics Ordinance, IVDO (under consultation at the moment), is enacted, IVD remain subject to the previous version of the MedDO, where the appointment of a Swiss Authorized Representative is not required for EEA-based manufacturers or foreign manufacturers with a EU Authorised Representative in a EEA country. It is however important to know that the current draft IVDO does not contemplate any “grace periods” for appointing a Swiss Authorised Representative for IVD manufacturers. Neither are any extended timelines allowed for the registration with Swissmedic of Swiss Authorized Representatives as economic operator. Therefore, IVD manufacturers should be ready with their Swiss Authorised Representative appointment and labelling by 26 May 2022 at the latest.

What happens with Procedure Packs and Systems?

Assemblers of medical device kits that correspond to the definition of Procedure Pack, per Article 2(10) of the EU MDR, or System, per Article 2(11) of the EU MDR, also need to appoint a Swiss Authorised Representative, per Article 51 §5 of the MedDO. The “grace period” is the same as that for Class I medical devices (see When do foreign manufacturers need to take action?). The MedDO does not provide any further details on the implications. Neither has Swissmedic provided guidance on its expectations yet. For example:

  • What exactly should the Swiss Authorised Representative verify?
    Should the verification be limited to the statement under Article 22 of the EU MDR? Should it include the verification of proof of mutual compatibility and/or verification of the conformity of the individual products contained in the Procedure Pack or System?
  • Is the Swiss Authorised Representative of a Procedure Pack or System expected to become also the Swiss Authorised Representative of the individual CE-marked devices therein?
    Or is the Swiss Authorised Representative of a Procedure Pack or System expected to verify that a Swiss Authorised Representative exists already for each individual CE-marked device therein?
    And what happens if any of such individual devices is an IVD, which does not yet require a Swiss Authorised Representative?
  • Is the Swiss Authorised Representative of a Procedure Pack or System expected to coordinate Vigilance reporting with the Swiss Authorised Representatives of the individual CE-marked devices therein?

In the absence of clarification there is a significant risk of uneven interpretation of the requirements and chaotic implementation across the entities offering Swiss Authorised Representative’s services. For this reason, Decomplix currently exerts extreme caution in endorsing the Swiss Authorised Representative role for Procedure Pack or System assemblers who are not also the legal manufacturer of the individual CE-marked devices therein, until Swissmedic brings clarity to this topic.

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

On 26 May 2022, Directive 98/79/EC on in-vitro diagnostic devices (IVDD) which is covered in the MRA will be replaced by the new Regulation 2017/746 (IVDR). In the absence of an updated MRA, IVD will no longer be covered by the MRA and will follow the same path as non-IVD medical devices. (See also What happens with in-vitro diagnostic medical devices (IVD)?)

Similar to the situation of IVD, it is safe to surmise that 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:

 2021-06-20 um 16.17.19

On 26 May 2022, Directive 98/79/EC on in-vitro diagnostic devices (IVDD) which is covered in the MRA will be replaced by the new Regulation 2017/746 (IVDR)

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), as there is a EU Commission proposal for a new Regulation. There is no information for now as to how Switzerland will prepare for it.

When do foreign manufacturers need to take action?

For EEA-based manufacturers, and manufacturers outside the EEA with a EEA-based EU Authorised Representative, the following “grace periods” for the appointment of a Swiss Authorised Representative were set forth in Article 104a of the MedDO:

  • Class III & implantable class IIb devices: 31 December 2021.
  • Non-implantable class IIb & class IIa devices: 31 March 2022.
  • Class I medical devices, Procedure Packs and Systems: 31 July 2022.

There are no differences in “grace periods” between EU MDR and MDD/AIMDD “legacy devices”.

As for foreign manufacturers located outside EEA (incl. the United Kingdom) who had not appointed a EU Authorised Representative, the need for a Swiss Authorised Representative applied already since 26 May 2021. 

As these “grace periods” are being reached, the affected devices can no longer be placed on the Swiss market if their manufacturer does not have a Swiss Authorised Representative.

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

The appointment of the SAR cannot happen overnight. Even once the manufacturer has identified the most convenient entity in Switzerland, the designation process entails, at a minimum:

  • Contract negotiation.
  • 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 mandate and the need for the foreign manufacturer to seek another Swiss Authorised Representative.
  • Implementing the Swiss Authorised Representative’s particulars on the device labelling, if and when required.

It is therefore recommended that manufacturers based in EEA countries or currently represented by a EU Authorised Representatives not based in Switzerland start the process preparation immediately

In case a foreign manufacturer considers there is a risk to run out of time in the designation of a Swiss Authorised Representative (e.g. a risk of mandate rejection), there might be a possibility to place the devices on the Swiss market via the Swiss Importer prior to the end of the “grace periods” per Article 104a of the MedDO, and build up stock at the Swiss distributor, who would then merely make available the devices on the market, as defined in Article 4 §1(a) of the MedDO.

What requirements apply to foreign manufacturers during the “grace periods” of the MedDO?

Because of the “grace periods” in Article 104a of the MedDO relative to the designation of a Swiss Authorised Representative, the following MedDO requirements cannot be expected to be immediately fulfilled by a Swiss Authorised Representative:

  • Responsibility for Vigilance reporting, under Article 66 of the MedDO.
    Until the Swiss Authorised Representative is appointed, such oversight role would have to be undertaken under the exclusive responsibility of the foreign manufacturer, per Article 66 §1 of the MedDO, instead of under the responsibility of the Swiss Authorised Representative, per Article 66 §2bis. This solution is also stated in the explanatory report on the MedDO revision issued by the Swiss Federal Office of Public Health (FOPH), which is only available in German, French or Italian. For now the Vigilance reporting channels remain via e-mail, using the appropriate forms (e.g. MIR or FSCA form) and the details on how to proceed are well described in Swissmedic’s Vigilance webpage.
    Moreover, per the information in this webpage and in Swissmedic’s Information Sheet on the Obligations of Economic Operators, the actual Vigilance report submission could be undertaken by either the foreign manufacturer of the Swiss Authorised Representative, and the Swiss Authorised Representative would retain responsibility for ensuring that such reporting happens.
  • Registration of Economic Operators within 3 months of their placing on the market of devices for the first time, per Article 55 §1 of the MedDO.
    Only after having accepted a foreign manufacturer’s mandate and starting placing devices on the Swiss market, would a Swiss Authorised Representative be in a position to send the initial request to Swissmedic in order to obtain a Swiss Registration Number (CHRN). Due to the “grace periods”, the registration of the Swiss Authorised Representative might occur later than that of the Swiss importer for a same foreign manufacturer.

What are the implications for Swiss Importers?

The Swiss Importer role is similar to the EU importer role and the MedDO has merely adapted to Switzerland the EU MDR’s duties of this economic operator. 

Although the Swiss Importer duties should be relatively straightforward, there was some confusion on how labelling and registration requirements have to be implemented. Swissmedic’s Information Sheet on the Obligations of Economic Operators and online event of 2-Sep-2021 have helped clarify.

On labelling requirements, per Article 53 of the MedDO, the Swiss Importer particulars must appear on the device or on the packaging or in a document accompanying the device. (For more details, see Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?)

In the absence of more specific guidance from Swissmedic, Decomplix recommends the use of the term “CH IMPORTER” in German, French and Italian, as follows : “CH IMPORTEUR / IMPORTATEUR / IMPORTATORE”, and to avoid the use of the importer symbol of ISO 15223-1, which could be mistaken for EU importer.

On the registration of Swiss Importers with Swissmedic, i.e. as economic operators, so to obtain a CHRN:

  • If the importer places EU MDR-compliant or “legacy” devices on the Swiss market for the first time after 26 May 2021, the registration must be done within 3 months.
  • If the importer had already placed EU MDR-compliant devices on the Swiss market for the first time before 26 May 2021, then they must register before 26 November 2021.
  • If the importer had already placed “legacy” devices on the Swiss market for the first time before 25 May 2021, there is no obligation to register.

Another very important aspect, as mentioned earlier, is that an entity becomes the Swiss Importer “by action” (i.e. by placing a medical device from abroad on the Swiss market) as opposed to by explicit designation of the foreign manufacturer. In practice, this restricts the possibility of a foreign manufacturer to ship goods directly to distributors or retailers, if such companies are not ready to endorse the duties of a Swiss Importer.

How can Decomplix help?

Decomplix offers Swiss Authorised Representative services. The 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.

More articles