Hi,
Yes, it's effective since yesterday, the "D-Day", and you can find it here, but only in the official languages of the Confederation :
RO 2020 2977 - Ordonnance sur les dispositifs médicaux (ODim) (admin.ch), means in French, German & Italian, but I'm quiet sure that an non official translation should exist, I will try to find it.
Because now Switzerland is considered as a 3rd country, companies who wants to make business with Swistzerland need a Swiss Representative, but the official law is basically build on the MDR 2017/745.
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Joël Kler
Regulatory Affairs & Quality Manager
Sonceboz
Switzerland
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Original Message:
Sent: 26-May-2021 19:18
From: Rashmi Pillay
Subject: Swiss law for medical devices
Hi,
Are the Swiss laws for medical devices already effective ? What are the mandates for the non-EU manufacturers?
Thanks & Regards,
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Rashmi Pillay
Regulatory Affairs Manager
Ellex – Lumibird Medical group
3-4 Second Ave, Mawson Lakes SA 5095 Tel. +61 8 7074 8105
Email rpillay@ellex.com
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