MRA between EU and Switzerland: Does it continue to apply or not?
Our last news on the MRA between the EU and Switzerland was entitled: “Mutual Recognition Agreement between Switzerland and the EU falls through.”
In the meantime, there is disagreement among prominent players in the Swiss medtech industry about the legally valid cessation of the old agreement. In addition, industry representatives on both the German and Swiss sides have spoken out in favour of cooperation that the EU Commission does not envisage.
Who says what?
First, there seems to be agreement that the Mutual Recognition Agreement (MRA) between EU member states and Switzerland has not been updated. As a result, the Swiss medical technology industry lost access – also according to the view held by reuschlaw – to a state that was put on an equal footing with the EU member states when the EU Medical Technology Regulation (MDR) came into force. Switzerland became a “third country” with all the attendant adverse consequences for economic actors in the EU and Switzerland.
The Swiss Federal Office of Public Health (FOPH) and the Swiss regulatory authority Swissmedic still take the position that the old MRA is not longer applicable because no update has been made.
The Swiss Federal Council takes the opposite view. In its view, the old MRA continues to apply even though it has not been updated. An answer of the Federal Council of 13 December 2021 to a question submitted to the National Council reads verbatim as follows: “The Mutual Recognition Agreement (MRA) continues to apply”.
The view of the Swiss Federal Council is shared in particular by the Swiss industry association Swiss MedTech, which on the one hand had consistently vehemently advocated the updating of the MRA and on the other hand persistently emphasised the multitude of consequences associated with the “third country status” for economic actors. A legal opinion commissioned by Swiss MedTech comes to the conclusion – as does the Swiss Federal Council – that the old MRA is still valid and applicable. “It was neither terminated nor suspended by means of notification”. The expert opinion can be accessed via the Swiss MedTech homepage.
Bilateral cooperation between Switzerland and Germany?
In a press release dated 26 May 2021 the EU Commission informed that following the failure of negotiations to update the old MRA between the EU and Switzerland, “mutual recognition and related trade facilitation for medical devices between the EU and Switzerland will no longer apply as of 26 May. This is related to the new Medical Devices Regulation, which comes into force in the EU on the same day”.
The proposal to provide for a limited amendment to the Mutual Recognition Agreement as a precautionary measure to allow a transition period for existing Swiss certificates of conformity until (at most) 26 May 2024, during which time existing certificates issued in the EU would also remain valid, was not implemented until 26 May 2021. As a result, the EU Commission concluded, among other things, that existing certificates (so-called “SQS certificates”) issued by a notified body domiciled in Switzerland would no longer be recognised by the EU.
As stated above, the Swiss industry association Swiss MedTech (as well as the Swiss Federal Council) is of the opinion that the old MRA is still valid and should be applied. But then the EU Commission violates the applicable law with regard to existing SQS certificates: Assuming the validity of the MRA, the existing certificates are to be recognised regardless of the date of application of the MDR in the EU member states.
Swiss MedTech’s position is supported among others by renowned German industry representatives, first and foremost BVMed. According to Swiss MedTech, BVMed has contacted the AG MP (Medical Devices Working Group of the Supreme State Health Authorities). The board of the ZLG is concerned with problems of the enforcement of medical device law and here in particular with the coordination of the cooperation of the countries. According to the assessment of the Working Group, the SQS certifications of the Swiss bodies still notified in accordance with Directives 90/385/EEC and 93/42/EEC (PDF) continue to be valid until the deadlines set out in Article 120(2) MDR. This means that Swiss manufacturers may continue to sell their MDD products with SQS certificates in Germany. However, an EC REP must be appointed for these products as a prerequisite.
Thus, it seems clear (for the time being) that “special conditions” apply to the cooperation between Switzerland and Germany. One consequence of this is that this exception cannot automatically apply to the other EU member states, which contradicts the idea of harmonisation and the principles of the free internal market per se. It remains to be seen what result the European Court of Justice, which has already dealt with the question of the continued validity of SQS certificates in all member states, will come to.
Recommendation for action
Based on a failure of the MRA, reuschlaw’s recommendation for action to distributors of medical devices manufactured in Switzerland was to be aware that they could (unintentionally) become importers and would have to comply with the legal obligations of importers of medical devices. Conversely, European manufacturers of medical devices and distributors with sales activities in Switzerland were advised to seek and mandate a Swiss Rep within the applicable designation period. This is still a possible option.
On the other hand, economic actors are in quite prominent company with the Swiss Federal Council, Swiss MedTech and a supplementary legal opinion when they take the position that the old MRA still applies and hence the known legal framework continues to apply to the cooperation of Swiss companies and economic actors of EU member states.
To end in the words of Swiss MedTech: “Each company must examine [pending the ECJ’s decision] for itself the extent to which it takes into account the official position of the Federal Council as well as the available legal opinions in its business decisions”.back