Jan 22, 2020

With a Mutual Recognition Agreement (MRA) necessary for the free movement of medical devices between the European Union and Switzerland still under negotiation for the Medical Devices Regulation (MDR), manufacturers should take steps now to ensure ongoing market access once the new Regulation comes into force in May 2020.

Mutual Recognition Agreement (MRA)

Switzerland is not an EU Member State, but it is linked to EU via bilateral treaties. From 2014 to 2018 the EU and Switzerland worked out a proposal which would involve free movement of persons, air transport, carriage of goods and passengers by rails and road, trade in agricultural products and mutual recognition of standards.

In these fields EU law would become applicable in Switzerland, with the European Court of Justice having the final word. However, the free movement of persons was voted down in a referendum, and it has not been possible so far to find a compromise in the current draft agreement.

Within that overarching agreement, Mutual Recognition Agreements (MRA) can be signed. The current Medical Device Directives are covered by such agreements, but the MRA for the MDR can only be signed if there is an agreement on the bigger treaty. This may take a while.

No clarity from Swiss authorities yet

At this moment the Swiss Competent Authority Swissmedic does not communicate anything about the consequences of not having the MDR MRA in place. There are two reasons for that.

The first is that the Swiss can allow marketing of devices CE-marked in accordance with the MDR independently. There is not an urgent problem regarding the availability of devices yet. On the longer term Switzerland may run into problems because they may also lose access to Eudamed and other EU communication channels, which would limit their market surveillance capabilities.

The second reason is that they may not be fully aware of the consequences because the current MRA regarding the Directives has recently been updated to cover Chapter IV of the MDR. A Swiss government representative has told Emergo that they expect there will be no problem to extend this MRA with the rest of the MDR as well. However, Chapter IV of the MDR covers Notified Bodies and how they are designated. It would make sense to allow Swiss organizations to become designated before the Date of Application; therefore this chapter was added to the current MRA. The fact that the rest of the MDR was not added in the same move suggests that the EU wants to keep these separate and covered under a new agreement.

The EU and the MRA problem

From a regulatory point of view the situation after the May 26, 2020 application date is clear: the MDR applies, there is no MRA with Switzerland covering the MDR, and therefore Switzerland becomes a “third country” from the EU’s perspective.

This means that Swiss manufacturers must have an Authorized Representative (AR)–with a Person Responsible for Regulatory Compliance (PRRC)–and an importer based in the EU. This concerns all devices, including devices relying on certificates issued under the Directives, as confirmed by industry association Swiss Medtech. For non-EU manufacturers relying on a Swiss AR, this means those companies will have to find a new AR, or their AR needs to move their location to an EU Member State. In all these situations the labelling needs to change. If these measures are not taken, it may no longer be possible to place such devices on the EU market. This may cause disruptions in the continuity of care in the EU.

Manufacturers may have to make changes in their quality systems because of the extra economic operators involved in distribution. In theory this may be considered a change in the quality system that would have an impact on CE Mark certification, but it would of course be better if Notified Bodies would not consider this a requisite for recertification.

What if the MRA should be signed?

The MRA may be signed in the future. This may be well after May of 2020. In that case a Swiss manufacturer will have access again to the EU market and will no longer have to depend on an AR and importer. This means their labelling will not be in compliance with the MDR and they will have to make additional changes. It is not clear what kind of transitional arrangements will be allowed. Manufacturers should therefore keep their alternative labelling design available and up to date, so they can launch this on short notice.

Because there is no information regarding the requirements for placing medical devices on the Swiss market as a non-Swiss manufacturer, it is also not possible to indicate what the consequences of the signing of the MRA would entail.

What to do?

For Swiss manufacturers exporting into the EU:

  • Appoint an AR with a PRRC that is independent of that manufacturer and based in the EU;
  • Appoint an importer;
  • Change labels and/or packaging so the details of the AR and the importer are presented in line with the MDR requirements.

For non-EU manufacturers importing into the EU, relying on Swiss ARs and/or importers:

  • Either move the address of the AR and/or importer to a Member State of the EU;
  • Or appoint a new, EU-based AR and/or importer;
  • Change labels and/or packaging so the new situation is presented in line with the MDR requirements.

For EU-based manufacturers exporting into Switzerland the situation is not clear. The Swiss authorities have so far not presented what they expect and how they will control access of medical devices to their market. Emergo consultants will provide further updates on the situation in Switzerland as we learn them.

Additional European MDR compliance resources: