Swiss Liberal Councilor Damian Müller (Source: Swiss Federal Assembly)wiss
The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators, such as the US Food and Drug Administration (FDA) to be marketed in Switzerland. Currently, only EU-certified products are allowed on the country’s internal market based on a mutual recognition agreement between Switzerland and the EU.
On 28 November, the lower house of the Swiss Federal Assembly, also known as the National Council, approved a motion that mandates the Swiss Federal Council to develop regulations to allow medical devices approved by non-EU regulators into the country. The motion had already been approved by the upper house, also known as the Council of States, on 30 May.
The Federal Council now must adapt its national law and present an implementation proposal to allow non-EU regulated medical devices for use in Switzerland, which could open the door to allowing FDA-approved devices onto the market.
The motion was first introduced into the Swiss parliament by Liberal Councilor Damian Müller in May 2020. He argued that the EU Medical Device Regulation (MDR), Switzerland’s own legal requirements for medical devices and the country’s limited resources have created serious hurdles for medtech manufacturers that could deprive patients of treatments.
Peter Biedermann, managing director of the lobby group Swiss Medtech, called the decision “forward-thinking” in a press release.
“It is a response to circumstances that could no longer be ignored,” he said. “Specifically, problems with the implementation of the new European medical device regulation and the negative consequences concerning availability, product range, and quality of medical devices throughout Europe.
“As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best,” he added.
By allowing products into the Swiss market that had already been vetted in the US, proponents argue that manufacturers will have easier access to the Swiss market, while the public can have confidence in the safety and efficacy of the products that have been reviewed by US regulators.
“The problems associated with the implementation of the new European Medical Device Regulation (MDR) are becoming increasingly apparent – throughout Europe,” Sandra Rickenbacher-Läuchli, legal counsel at Swiss Medtech told Focus. “The additional administrative workload leads to cost increases for medtech companies and ties up a lot of research and development capacities at the expense of innovations.”
The group says more than 1,000 of the approximately 5,000 foreign medtech manufacturers have already stopped supplying products to Switzerland. The lobby group Medtech Europe also says that according to its survey, half of medtech manufacturers in Europe say they plan to reduce their portfolio due to the added burdens from the MDR.
“Due to its size, Switzerland is – like other countries – not in a position to supply itself with all the medical devices it needs and is therefore dependent on imports,” said Rickenbacher-Läuchli. “At the moment, only medical devices with an EU certificate are allowed on the Swiss market.”
Rickenbacher-Läuchli did not address whether there are potential local legal hurdles the Swiss government may face trying to implement the decision and whether it would apply not just to FDA-approved products but also those that have been cleared or otherwise authorized by the agency. She said that for now, the Swiss government has two years to implement the proposal which will be written by the responsible administrative bodies. The issue will be examined by stakeholders in more detail in the coming months, she added. It also remains to be seen whether the proposal applies to any other foreign regulators besides FDA.
Rickenbacher-Läuchli added that Swiss Medtech plans to stay engaged to bring the industry perspective to policymakers as they go through the implementation process.
On 28 November, the lower house of the Swiss Federal Assembly, also known as the National Council, approved a motion that mandates the Swiss Federal Council to develop regulations to allow medical devices approved by non-EU regulators into the country. The motion had already been approved by the upper house, also known as the Council of States, on 30 May.
The Federal Council now must adapt its national law and present an implementation proposal to allow non-EU regulated medical devices for use in Switzerland, which could open the door to allowing FDA-approved devices onto the market.
The motion was first introduced into the Swiss parliament by Liberal Councilor Damian Müller in May 2020. He argued that the EU Medical Device Regulation (MDR), Switzerland’s own legal requirements for medical devices and the country’s limited resources have created serious hurdles for medtech manufacturers that could deprive patients of treatments.
Peter Biedermann, managing director of the lobby group Swiss Medtech, called the decision “forward-thinking” in a press release.
“It is a response to circumstances that could no longer be ignored,” he said. “Specifically, problems with the implementation of the new European medical device regulation and the negative consequences concerning availability, product range, and quality of medical devices throughout Europe.
“As innovations are increasingly being introduced first to the market in the USA, new products reach Europe with a delay, at best,” he added.
By allowing products into the Swiss market that had already been vetted in the US, proponents argue that manufacturers will have easier access to the Swiss market, while the public can have confidence in the safety and efficacy of the products that have been reviewed by US regulators.
“The problems associated with the implementation of the new European Medical Device Regulation (MDR) are becoming increasingly apparent – throughout Europe,” Sandra Rickenbacher-Läuchli, legal counsel at Swiss Medtech told Focus. “The additional administrative workload leads to cost increases for medtech companies and ties up a lot of research and development capacities at the expense of innovations.”
The group says more than 1,000 of the approximately 5,000 foreign medtech manufacturers have already stopped supplying products to Switzerland. The lobby group Medtech Europe also says that according to its survey, half of medtech manufacturers in Europe say they plan to reduce their portfolio due to the added burdens from the MDR.
“Due to its size, Switzerland is – like other countries – not in a position to supply itself with all the medical devices it needs and is therefore dependent on imports,” said Rickenbacher-Läuchli. “At the moment, only medical devices with an EU certificate are allowed on the Swiss market.”
Rickenbacher-Läuchli did not address whether there are potential local legal hurdles the Swiss government may face trying to implement the decision and whether it would apply not just to FDA-approved products but also those that have been cleared or otherwise authorized by the agency. She said that for now, the Swiss government has two years to implement the proposal which will be written by the responsible administrative bodies. The issue will be examined by stakeholders in more detail in the coming months, she added. It also remains to be seen whether the proposal applies to any other foreign regulators besides FDA.
Rickenbacher-Läuchli added that Swiss Medtech plans to stay engaged to bring the industry perspective to policymakers as they go through the implementation process.
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