It is there now, 26 May 2021. The new Medical Device Regulation in Europe (MDR, Regulation (EU) 2017/745) and the new Medical Devices Ordinance in Switzerland (MedDO, SR 812.213) are mandatory from now on. We in Switzerland are now also confronted with a (still) not fully functional MDR in Europe and a not completely identical implementation of EU law at the Swiss ordinance level. The latter disclosed now the suspected serious import barriers for EU manufacturers. In the context of the previous discussions on the future third country status of Swiss manufacturers, these new obstructions are to be classified as reactive measures. Unfortunately, they further worsen the already tense supply situation during the introduction of the new regulations. In addition, the mentioned escalation has certainly also contributed to the fact that European trade barriers currently apply to all Swiss medical devices that are to be brought into the EU area. It is therefore also not really a surprise that the facilitations discussed between the EU and Switzerland shortly before the date of application for the trade in old-regulated products – in accordance with the previous directives and already placed on the market outside Europe – can hardly be successfully concluded.

In the current delicate situation, it is therefore essential for Swiss medical device manufacturers and export organisations to prepare well and as comprehensively as possible for the current situation and for any difficulties that may arise. At the same time, however, it would be desirable if they could also lobby through their representatives (i.e., specifically their associations) for the entry into force of a version of the ordinance that meets their needs. After all, the sooner Switzerland has a robust MedDO, the less potential collateral damage there will be. The fact that adjustments can be made very quickly if necessary is shown by the most recent amendment to the foreseen new version of the MedDO, which has been announced since mid-2020. One week before the date of application of the MDR, this one had to be quickly adapted and adopted, due to the unresolved relationship issues with the EU..

Risk Assessments are Key
Even after 26 May 2021, much remains unclear, also within the EU. For example, the EU Commission, through its technically responsible directorate, DG Sante, has not yet officially commented on a recommendation on the Swiss products affected by the new import barriers. Apparently, the EU also has some respect for officially communicating to its member states its extreme interpretation of the applicability of the technical trade agreement, the MRA Switzerland-EU. Until now, the EU Commission has strictly followed an interpretation according to which the agreement for medical devices, with repealed EU directives, would no longer be applicable in principle. A controversial position under international law (at least according to some legal experts).

Ultimately, of course, the EU hopes that a breakthrough can still be achieved in the institutional framework agreement with Switzerland, the actual reason for the currently suspended barrier-free trade in medical devices. Therefore, before resorting to further escalation steps, feasible negotiation options should possibly be exhausted first.

For Swiss economic operators, this means that, because the relationship between Switzerland and the EU has still not been conclusively clarified and the legal issues surrounding the MRA are still open, it is not only interpretations of legal and treaty texts that need to be considered. It is equally important to plan and carry out EU exports considering an assessment of further potential risks. This is the way to determine and quantify conceivable risks. For example, how important a product intended for export may be for the destination markets or what local intervention possibilities might be.

MDR helps…
From the date of application of the MDR, EU Member States would also have to follow the principles of their EU Regulation set out in Section 3 when carrying out market surveillance.

The national competent authorities for market surveillance would therefore have to differentiate between ‘unacceptable risks to health and safety’ (MDR, Art 95 and 96) and ‘other risks’ (MDR, Art 97) in the case of identified non-compliances. The unacceptable risks are even specified as “…may present….to the health or safety of patients, users or other persons, or other aspects of the protection of public health” (MDR, Art 94a). The national competent authorities would also have to enforce their corrective measures in a differentiated manner, along the lines of classified risks.

It cannot be in the spirit of Section 3 of the MDR if a national competent authority would classify an identified non-compliance in the fulfilment of third country requirements as an unacceptable risk. Rather, the national competent authorities would have to require the relevant economic operators to put an end to identified non-conformities within a period proportionate to the non-conformity (i.e., applying the MDR, Art 97, para 1). As ‘proportionate’ will certainly also be determined by the demand for such non-conforming products (at the time of the market surveillance carried out), the period for ending the identified non-conformities may vary from one Member State to another. In extreme cases, there may even be an import blockade or rejection of these products at individual import borders. All these aspects must be taken into consideration as far as possible in the risk assessment.

As long as Member States react with their individual approaches to imported products from Switzerland and a re-applicability of the MRA remains unclear, all CE-marked products from Switzerland should be switched to third country requirements. Nevertheless, in conjunction with the most comprehensive risk assessment possible, even the export of products that have not yet been fully converted to the requirements of third countries would not necessarily have to be stopped completely under the MDR. This is particularly the case if a clear and time-limited conversion plan can be submitted on request for all these products.

Author: Peter Studer (Senior Advisor)