Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, we have a Class IIb, non-active implantable device and I have been asked to provide the regulatory pathway for marketing (through a distributor) in Switzerland.  Since Switzerland is not part of the EU, but seems to follow the MDR to some degree, I am confused as to whether or not CE mark is required and what the actual process is to get devices into this country.  I did review this: Regulation of medical devices

Swissmedic		remove preview
Regulation of medical devices Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For these devices, Switzerland has taken over the European Union (EU) system of compliance assessment and certification, based on bilateral agreements. Compliance with internationally valid norms is evaluated by private entities. Medical devices are attributed to various categories that require varying assessment procedures. View this on Swissmedic >

but again, it seems to follow MDR. Can someone provide refer to or provide me with a reg. pathway? Thank you,

Good morning

Switzerland is considered a 3rd country to the EU since 26 May 2021 because the Mutual Recognition Agreement was not fully renewed to cover the MDR. However, Swiss law (the Medical Devices Ordinance, MedDO) was built up in a way it's equivalent to the MDR. You can find it here: SR 812.213 - Medical Devices Ordinance of 17 October 2001 (MedDO) (admin.ch)

Since products that are CE marked in the EU can also be placed on the market in Switzerland, this is the least burdensome approach. Anyway, there are a few specifics, e.g. that MedDO requires foreign manufacturers to nominate a Swiss Authorized Representative (CH REP). More information regarding this can be found here: Swiss authorised representative (CH-REP) (swissmedic.ch) Furthermore you need to have your instructions for use available in 3 official languages (German, French, Italian) etc.

Please reach out to me if you need more information.

Cheers, Beat

------------------------------
Beat Steffen
Founder & CEO
Oberkirch
Switzerland
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Original Message:
Sent: 09-Jul-2021 12:10
From: Anonymous Member
Subject: Device Regulations in Switzerland

This message was posted by a user wishing to remain anonymous

Hello, we have a Class IIb, non-active implantable device and I have been asked to provide the regulatory pathway for marketing (through a distributor) in Switzerland.  Since Switzerland is not part of the EU, but seems to follow the MDR to some degree, I am confused as to whether or not CE mark is required and what the actual process is to get devices into this country.  I did review this: Regulation of medical devices

Swissmedic		remove preview
Regulation of medical devices Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For these devices, Switzerland has taken over the European Union (EU) system of compliance assessment and certification, based on bilateral agreements. Compliance with internationally valid norms is evaluated by private entities. Medical devices are attributed to various categories that require varying assessment procedures. View this on Swissmedic >

but again, it seems to follow MDR. Can someone provide refer to or provide me with a reg. pathway? Thank you,

Original Message:
Sent: 7/9/2021 12:10:00 PM
From: Anonymous Member
Subject: Device Regulations in Switzerland

This message was posted by a user wishing to remain anonymous

Hello, we have a Class IIb, non-active implantable device and I have been asked to provide the regulatory pathway for marketing (through a distributor) in Switzerland.  Since Switzerland is not part of the EU, but seems to follow the MDR to some degree, I am confused as to whether or not CE mark is required and what the actual process is to get devices into this country.  I did review this: Regulation of medical devices

Swissmedic		remove preview
Regulation of medical devices Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For these devices, Switzerland has taken over the European Union (EU) system of compliance assessment and certification, based on bilateral agreements. Compliance with internationally valid norms is evaluated by private entities. Medical devices are attributed to various categories that require varying assessment procedures. View this on Swissmedic >

but again, it seems to follow MDR. Can someone provide refer to or provide me with a reg. pathway? Thank you,