Swiss Medtech calls for revision of the national Medical Devices Ordinance
This year’s Swiss Medtech conference on medical device regulations will focus on the realities of third-country status – concerning its most important trading partner the European Union (EU) – which has applied for the Swiss medical technology industry since last May. What are the consequences of the blockade with the EU for the Swiss medtech industry; a sector that has historically been so successful? What are the most pressing problems and how can they be solved? Over 500 industry representatives are meeting today to discuss the situation, and possible solutions.
Exports: The industry has adapted well
The industry had largely anticipated the third-country scenario and spent two years painstakingly preparing for the additional requirements needed to guarantee seamless export of goods to the EU. These include the appointment of an authorised representative in the EU area – responsible for product relabelling, and the assumption of specific tasks and joint product liability on behalf of the manufacturer. Today, almost all companies meet these conditions. The legal situation is clear: anyone wanting to export ¹MDR products to the EU must fulfil third-country requirements. In contrast, legal uncertainty regarding medical devices with existing certificates (so-called ²MDD products or old-law products) continues. Can they benefit from the transitional period until the end of 2024 or not? The EU says no, Switzerland says yes. Currently, companies are forced to evaluate their own risks within a state of legal limbo.
Imports: Alarming situation – patient care at risk
With the implementation of the national Medical Devices Ordinance (MepV) on 26 May 2021, the Federal Council increased the import criteria for foreign manufacturers. In doing so, the Swiss authorities are not only harming the domestic medtech industry but are also endangering the health care of their own population. Industry surveys show that one in eight medical products currently used in Switzerland will no longer be available in the future. The reason: not all foreign manufacturers are prepared to meet additional requirements solely for the small Swiss market. «At the moment we are aware of isolated disruptions in supply. From the second half of next year, noticeable gaps will become apparent across the board,» Dr Daniel Delfosse, Head of Regulatory Affairs at Swiss Medtech, is convinced.
Already in spring of this year, the association, together with other healthcare stakeholders, drew attention to the alarming situation in an open letter to the Federal Council. Without success: the MepV, including its high import hurdles, was formally introduced.
The association is aware that the Swiss Federal Council is not the only entity with influence over the ³MRA update and also does not have sole control of the mutual free trade in goods. The EU must be open to discussions as well. «It is therefore all the more important that the Federal Council uses its power to unilaterally formulate the MepV with import regulations beneficial to Switzerland, independent of the EU. This has not happened so far,» says Delfosse. By accepting the MepV, Switzerland has made the law adopted by the EU (MDR) even stricter (Swiss Finish). «The proposal does not function in real terms and we call for immediate changes. The impending supply problems could be reduced significantly with just a few adjustments to the regulation, and the Swiss government has the power to do so in its hands,» says Delfosse.
The future: A solid foundation for relations with the EU
In addition to the short-term negative consequences, the long-term damage to Switzerland as an attractive medtech location should not be forgotten. «Many decision-makers do not seem to be aware of how the blockade with the EU has already damaged, and will continue to diminish, Switzerland’s attractiveness as a centre of business and research. The association will therefore continue to work with partners and in alliances with unwavering commitment to ensure that Switzerland’s relationship with the EU is placed on a solid and lasting footing,» says Beat Vonlanthen, President of Swiss Medtech.
Brief review of European medtech policy
26 May 2021 was the cut-off date for the medtech industry: the new European ¹Medical Device Regulation (MDR) replaced the old EU Directives (²Medical Device Directive, MDD). The national Medical Device Regulation (MepV) came into force. The Federal Council broke off negotiations on the Institutional Framework Agreement with the EU, and abruptly lost the chance for a timely update of the ³Mutual Recognition Agreement (MRA) for bilateral free trade of medical devices. The absence of an MRA amendment relegated the Swiss medtech sector to third country status. The EU Commission announced that, effective immediately, Swiss certificates would no longer be recognised in the EU and that products with existing certificates issued by an EU body would no longer benefit from the transitional period lasting until May 2024.
Swiss Medtech represents more than 750 members in its role as industry association for Swiss medical technology. With 67,500 employees and a contribution of 11.5% to the positive trade balance, medical technology is an economically significant sector in Switzerland. Swiss Medtech advocates for conditions that enable the medtech industry to perform at peak capacity and provide first-class medical care.