Now that the world is done dealing with the Brexit drama, there is more on the plate for the EU Commission.
The EU Commission has a Mutual Recognition Agreement with the Switzerland Parliament to allow for Swiss-approved medical devices to be placed on the European market. This agreement allows for Switzerland to take over the EU system of compliance assessment and certification which is the EU Medical Device Directives.1
Now that we are just days away from the EU Medical Device Regulations implementation date, the industry stakeholders that manufacture their products in Switzerland and that have parts of their supply chain in Switzerland are concerned about their future operations. The Mutual Recognition Agreement between the EU and the Swiss needs to be updated to include the new EU MDR and because of the current political tension between the two countries, no agreement has been reached yet.
As a result of this, to regulate medical devices, Switzerland will become a third country on the date of application of the EU MDR. This means that Swiss manufacturers will have to set up an EU authorized representative and have their CE mark transferred to an EU Notified Body. Also each time an EU law is updated, Switzerland will be left out and fall within the third country category.2
There is no doubt that if an agreement is not reached in time, this will cause disruption for Swiss medical device manufacturers and they will have to make special arrangements to stabilize their EU distribution and supply chain channels. Whether this arrangement will be temporary or permanent, and what the new Swiss Medtech transition plan looks like for medical device industry stakeholders, will be discussed in part II of this blog.
Whatever the changes are, rest assured that EMMA International is here to assist you with all your compliance needs, call us today at 248-987-4497 or email us at firstname.lastname@example.org to learn more.
1Swissmedic(2019) Regulation of medical devices retrieved on 04/24/2021 from https://www.swissmedic.ch/swissmedic/en/home/medical-devices/regulation-of-medical-devices.html
2Bristows (2020) MDR postponement staves off Swixit – for now retrieved on 04/24/2021 from https://www.bristows.com/news/mdr-postponement-staves-off-swixit-for-now/