Swiss Authorised Representatives for medical device manufacturers

Have you heard about Swiss Authorised Representatives for medical device manufacturers yet?

Suppose you have been following the recent developments in the negotiations between Switzerland and the EU concerning the institutional agreement (InstA). In that case, you might have heard about the role of the so-called Swiss Authorised Representative. The agreement between Switzerland and the EU covers different bilateral agreements, including the single market access based on the mutual recognition of conformity assessments. Because the current Mutual Recognition Agreement (MRA) that includes medical devices does not cover the upcoming Regulation (EU) 2017/745 on medical devices, access to the markets could become considerably more difficult.

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

Content:

Why is this a problem, who is affected and what is the impact?

Under the existing Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) that governs the mutual access of medical devices to the markets, the current European Directives 93/42/EEC concerning medical devices (MDD), 90/385/EEC on active implantable medical devices (AIMD) and 98/79/EC on in-vitro diagnostic medical devices (IVD) are fully adopted under the Swiss Medical Device Ordinance (MedDO, SR 812.213). This is why importing CE-marked devices into Switzerland is today indistinguishable from importing them into any other EU Member State or EFTA country. This might no longer be the case after 26 May 2021.

The existing MRA does not cover the upcoming European Regulation (EU) No. 2017/745 on medical devices (EU MDR), which shall replace the MDD and AIMD and become applicable on 26 May 2021. The MRA needs to be updated, and this is unlikely to happen in time as the EU Commission has stated that it will not negotiate or update existing MRAs until the institutional agreement (InstA) has been concluded. The current political situation makes it highly unlikely that the InstA and the MRA will be updated before 26 May 2021. It is worth noting that the negotiations are stalled on aspects that have nothing to do with mutual recognition of conformity assessment and are political points of contention, such as wage protection, state aid, and the extent to which EU immigrants can benefit from the Swiss social system.

Without an updated MRA, Switzerland would be viewed as a “third country” under the new EU MDR, and EU/EFTA countries would be viewed as “third countries” under Swiss legislation on medical devices. In 2020, Switzerland already revised its medical device legislation to be prepared for alignment with the EU MDR, and to have it apply simultaneously, on 26 May 2021. Under this revised version of the Swiss Medical Device Ordinance, manufacturers located outside of Switzerland need a Swiss Authorised Representative (in German: bevollmächtigte Person, and French: personne mandatée). The revised version of the Swiss MedDO (SR 812.213 of 1-Jul-2020) is only available in German and French for now. Suppose the EU MDR enters into application in the absence of an updated MRA and Switzerland maintains the entering into force of the revised MedDO on the same date. In that case, medical device manufacturers established in EU/EFTA countries or established elsewhere and represented by EU Authorised Representative will 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 will repeal the current MDD and AIMD, the existing MRA will be obsolete, and a Swiss Authorised Representative will be 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.

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The appointment of an authorised representative cannot happen overnight.

What are the possible scenarios and their implications?

As long as the negotiations’ outcome is unclear, the industry has to prepare for different regulatory requirements based on what is known so far, which is admittedly little and somewhat shaky due to the continually changing situation during the pandemic. Switzerland continues to prepare a new version of the revised Swiss MedDO that should provide more details about this situation. The new version will shed light on the requirements applicable to the Swiss Authorised Representative that are insufficiently addressed in the current version. Although at this point of time a new postponement of the EU MDR due to the Covid-19 pandemic cannot be completely ruled out, all stakeholders recognize it is important for foreign manufacturers to start preparing for the likely need of a Swiss Authorised Representative from 26 May 2021, to ensure there is no commercialization disruption.

This leaves the industry with the following three possible regulatory scenarios:

TEMPORARY UPHEAVAL

If:

  • the EU MDR enters into application on 26 May 2021 (i.e. the date is not postponed again, as it was last year due to the COVID pandemic situation) plus the revised MedDO comes into force on the same day, and
  • the MRA can be expected to be updated at a later date.

Then:

  • a Swiss Authorised Representative would be needed, from 26 May 2021 (or after a grace period, if introduced in the updated version of the revised MedDO) and for as long as the MRA is not updated, which could take a few years.

PERMANENT UPHEAVAL

If:

  • the EU MDR enters into application on 26 May 2021 (i.e. the date is not postponed again, as it was last year due to the COVID pandemic situation) plus the revised MedDO comes into force on the same day, and
  • the MRA will not be updated at all or will be withdrawn.

Then:

  • Switzerland will undoubtedly establish its own regulatory basis for medical device clearance, similar to what the UK has done post-BREXIT, which would involve another revision of the relevant legislation, and could take several years. Therefore, the need for a Swiss Authorised Representative would become permanent and supplemented with the requirements imposed by Switzerland’s regulatory clearance path.

TEMPORARY HOPE

If:

  • the EU MDR’s date of application is postponed again for one year (e.g., due to the COVID-19 pandemic situation), making the EU MDR become applicable at the same time as the IVDR, i.e. Regulation (EU) NO. 2017/746 on in-vitro diagnostic devices.

Then:

  • the MRA could possibly be updated in the interval. Therefore, a Swiss Authorised Representative would not be needed, at least in 2021.

This last scenario is purely speculative but not completely impossible. The EU MDR implementation delays on many fronts (e.g., Notified Body designation, Harmonised Standards under EU MDR, MDCG guidance documents, EUDAMED) would be arguments in favor of a new postponement. Decomplix closely monitors any signs of such a possibility and keeps this blog post updated accordingly.

What is a Swiss Authorised Representative?

Per the definition in Article 4, paragraph 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 authorities, and becomes legally liable for defective devices, on the same basis and jointly and severally with the manufacturer. Article 51 of the revised Swiss MedDO describing a 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.

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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 authorities.

What are the duties of the Swiss Authorised Representative?

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 blogpost. The duties of a Swiss Authorised Representative set forth in Article 51 of the MedDO call out those of an EU Authorised Representative in Article 11 of 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 under Article 12 of the EU MDR.

Per Article 51 of the MedDO, respectively Article 11 of the EU MDR, the duties of a Swiss Authorised Representative include:

  • To comply with the registration obligations in Switzerland under the revised MedDO.
  • 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.
  • To verify that the device labelling fulfills the requirements of the MedDO.
  • To keep available a copy of the Technical Documentation, the EU 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).
  • Upon request from the competent authority, 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 by the competent authority for samples, or access to a device and to verify that the competent authority receives the samples or is given access to the device.
  • To cooperate with the competent authority 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.

There are certain manufacturer’s obligations that cannot 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.

Like for the EU Authorised Representative, the Swiss Authorised Representative’s particulars are expected to be required on the device labeling of the units intended to be imported and made available in Switzerland. However, the specific requirements are not described in the current version of the revised Swiss MedDO. This is anticipated to be addressed in the new version that is not yet published.

When do foreign manufacturers need to take action?

The appointment of an authorised representative 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 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 (including the medical device’s Technical Documentation).
  • Implementing the Swiss Authorised Representative’s particulars on the device labelling, as required.

It is therefore recommended that manufacturers based in EU/EFTA countries or currently represented by an EU Authorised Representative not based in Switzerland start the process preparation as soon as possible while keeping the implementation phase for a later stage, once it is clear that the EU MDR will not be postponed again and the revised Swiss MedDO will become applicable simultaneously, as planned, on 26 May 2021.

What can I do now?

Decomplix is preparing the offering of all-encompassing Swiss Authorised Representative services. The services include instructions and checklists for your understanding of the applicable requirements. In addition, Decomplix will provide contract templates and standard operating procedures to make the process as swift and smooth as possible.

If you are interested to know more, please contact us here

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