Swiss authorised representatives for medical device manufacturers
Have you heard about Swiss Authorised Representatives for medical device manufacturers yet? Here is all you need to know about it.
Replaces the previous version of 05.02.2021
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 the revised MedDO, medical device manufacturers who are not based in Switzerland, which now includes those based in EEA countries and those having a EU Authorized 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.
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. You can also find answers to frequently asked questions that we are currently receiving from various quarters as Decomplix provides Swiss Authorised Representative services.
- What has happened with medical devices in Switzerland? What is the MRA? What is the MedDO?
- What is a Swiss Authorised Representative?
- Is a Swiss Authorised Representative needed for all types of medical devices?
- What are the duties of the Swiss Authorised Representative?
- What UDI registration requirements apply to the Swiss Authorised Representative under the revised MedDO?
- Is the Swiss Authorised Representative also the Swiss Importer?
- Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?
- What happens with in-vitro diagnostic medical devices (IVD)?
- What happens with Procedure Packs and Systems?
- How is other EU legislation calling for CE-mark that might be relevant for medical devices affected?
- When do foreign manufacturers need to take action?
- What actions do foreign manufacturers need to take on the Swiss market?
- What requirements apply to foreign manufacturers during the transitional periods of the revised MedDO?
- How can Decomplix help?
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 (AIMD) 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 the 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 AIMD, 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 AIMD) 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.
What is a Swiss Authorised Representative?
Per the definition in Article 4 §1(g) of the revised 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.
Is a Swiss Authorised Representative needed for all types of medical devices?
The Swiss Authorised Representative is required under the revised MedDO for:
- all medical devices, including custom-made devices and products without a medical purpose listed in Annex 1 of the revised MedDO, but excluding in-vitro diagnostic medical devices, which are not concerned by the revised MedDO (see also: What requirements apply to 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 revised 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/AIMD.
What are the duties of the Swiss Authorised Representative?
Article 51 of the revised 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, 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.
Pursuant to Article 51 of the revised 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 labeling fulfils the requirements of the revised 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 revised 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 revised 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 revised MedDO.
In addition, Article 66 §2bis of the revised MedDO requires that the Swiss Authorized Representative be responsible for 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.
Also, per Article 55 §1 of the revised MedDO, the Swiss Authorized Representative needs to register for its economic operator role with Swissmedic and such 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. 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 revised 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 labels of the device units intended to be imported and made available in Switzerland. See also: Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?
Last, as required under Article 52 of the revised 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.
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 67c 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 revised MedDO. This article had been included in a preliminary draft of the revised 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 revised MedDO.
The duties of the Swiss Importer for medical devices are governed by Article 53 of the revised 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, custom 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.
The duties of a Swiss Importer per Article 53 of the revised MedDO are similar to those of the EU importer under the EU MDR. In addition, the Swiss Importer shall register with Swissmedic within 3 months of its first placing of devices on the Swiss market, per MedDO Article 55 §1. This entails obtaining the Swiss Registration Number (CHRN).
Do foreign manufacturers need to change the device labelling? Also for “legacy devices”?
The revised MedDO does not explicitly require that the Swiss Authorised Representative’s particulars appear on the device labelling.
Now, Article 6 §2 of the revised 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 revised 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/AIMD. And the Essential Requirements (ER) in Annex I of the MDD or Annex 1 of the AIMD also call for the authorized representative’s name and address to be mentioned on the device labelling, both on the package label and on the instructions for use. In Swissmedic’s information sheet of 17.06.2021 it is explicitly indicated that the Swiss Authorised Representative’s particulars are not required on the instructions for use, the device itself, or in the documents enclosed with the product (delivery note, commercial invoice).
Decomplix considers that:
- All units of the devices placed on the Swiss market under a Swiss Authorised Representative’s mandate should bear the Swiss Authorised Representative’s particulars. Therefore, the timelines for labelling would be de facto driven by the point in time when such device units under the Swiss Authorised Representative’s responsibility are imported into Switzerland. This would therefore be the case after the manufacturer has appointed the SAR.
- A permanent sticker with the Swiss Authorised Representative’s particulars added to the existing outer packaging of the unit of sale might suffice. The over-labelling could possibly be undertaken by the Swiss Importer.
The Swiss Authorised Representative’s particulars on the packaging must be preceded by either the new symbol below or any of the following texts: “CH authorised representative” / “CH-REP” / “Authorised representative for Switzerland”.
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 revised MedDO does not apply to in-vitro medical devices (IVD), with the exception of Articles 105 and 107. Specifically, Article 105 of the revised 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 revised MedDO. The “grace period” is similar to that for Class I medical devices (see: When do foreign manufacturers need to take action?) The revised 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 Manufacturer’s services. For this reason, Decomplix is currently delaying the offering for those 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:
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?
Immediately for any foreign manufacturer not eligible for the “grace periods” in Article 104a of the revised MedDO, i.e. manufacturers located outside EEA (which now includes the United Kingdom) who have not appointed a EU Authorised Representative. In this case, the need for a Swiss Authorised Representative applied from 26 May 2021. 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 apply:
- Class III & class IIb implantable devices: 31 Dec 2021.
- Class IIa & class IIb non-implantable 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/AIMD “legacy devices”.
What actions do foreign manufacturers need to take on the Swiss market?
The appointment of the SAR can happen anytime until the end of the corresponding “grace period”. However, it 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 the communication processes.
- 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 label, as required.
It is therefore recommended that manufacturers based in EEA countries or currently represented by a EU Authorised Representative not based in Switzerland start the process preparation as soon as possible. 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 revised MedDO, and build up stock at the Swiss distributor, who merely makes 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 revised MedDO?
Because of the “grace periods” in Article 104a of the revised 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:
- Vigilance reporting, under Article 55 of the revised MedDO. Until the Swiss Authorised Representative is appointed, such reporting would have to be undertaken by the foreign manufacturer directly, per Article 66 §1 of the revised MedDO, instead of by the Swiss Authorised Representative, per Article 66 §2.
This interim 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.
- Registration of Economic Operators (i.e. manufacturers or their SARs, and Swiss importers) within 3 months of their initial placing on the market of devices, per Article 55 §1 of the revised MedDO. This would be a matter of obtaining the Swiss Registration Number (CHRN) from Swissmedic by sending the completed CHRN request form via e-mail. Economic operator registration process is only intended for Swiss-based companies. A delayed registration of the Swiss Authorised Representative by virtue of the “grace periods” might result, for example, in the Swiss importer registering its activities for a same foreign manufacturer much earlier.
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.