In addition to the shortage of medicines in Switzerland, medical devices are also in short supply in some cases. The main reason: the EU’s stricter authorisation requirements. | Have you had any experiences with this?

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>”We have weekly enquiries due to delivery problems and have to look for alternatives,” explains Severine Dziergwa. Dziergwa is Team Leader of Interventional Radiology at the University Hospital Basel. Catheters, for example, are required for many minimally invasive procedures.

>However, these and many other products are becoming increasingly difficult to obtain. “It takes a lot of effort to get hold of other products. And it requires a high degree of flexibility from employees,” says Dziergwa.

>__Stricter EU regulation__

>The main reason for the shortage: the Medical Device Regulation, or MDR for short, introduced by the EU in 2017 in response to defective breast implants. It is intended to increase patient safety. This is why all medical devices – including those that have already been authorised – must be re-examined.

>To make matters worse, there are fewer testing centres in the EU, which massively increases the waiting time for approval.

>__Swiss companies are moving to North America__

>The new EU regulations also have an impact on Swiss medtech companies. For example, Stimit AG, a start-up that wants to revolutionise artificial respiration for patients in intensive care units with its innovative ventilator. The product was developed in Switzerland, the first clinical trials were carried out here and it is also manufactured here. And yet it is currently in the process of being approved for Canada and the USA.

>The effort required for a European authorisation would be too high, explains Managing Director Ronja Müller-Bruhn. It would be almost impossible to get an appointment for authorisation and “a lot more documents and studies would be needed overall. I would have to calculate three to five times the budget that I did a few years ago,” says Müller-Bruhn.

>__Politicians demand a solution – implementation is stalling__

>Several years ago, Damian Müller, member of the Lucerne Council of States and President of Swiss Medtech, therefore submitted a motion calling for products authorised outside the EU to be able to be used in Switzerland. Parliament approved the motion a year and a half ago – but it has not yet been implemented. “It’s simply taking far too long. Together with the industry, we now need a pragmatic way to ensure security of supply and patient safety,” criticises Müller.

>The Federal Office of Public Health is in charge of implementing the initiative. On request, the FOPH writes that the authorisation systems outside the EU are currently being examined “to determine how this motion can be implemented without jeopardising patient safety”. However, it is not yet possible to say when an amendment can be expected.