In Switzerland the Medical Devices Ordinance, in force since 1st January 2002, integrates the European medical devices directives on active implants, medical devices and in vitro diagnostic medical devices into Swiss law.
With the entry into force on May 26th 2017 of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR), a revision of the Medical Device Ordinance was required to cover all points arising from these new Regulations. The latest revision was adopted by the Swiss Federal Council on 25th October 2017 and applies as of 26th November 2017.
By aligning to the EU legislation Switzerland ensures that Swiss patients can also benefit from the intended improvements in patient safety as well as from the new information transparency with regards to medical devices set forth by the new EU Regulations. At the same time it allows Switzerland to continue to participate as an equal partner in the European internal market for medical devices.
What does this mean to you?
These rapid adjustments ensure that the Mutual Recognition Agreement and bilateral agreements relating to medtech are not put into question and that the Swiss conformity assessment bodies, two at this point in time (SQS, Zollikofen; and QS Zurich AG), are able to apply for designation as “EU notified bodies” under the MDR/IVDR as of November 26th 2017.
For Swiss manufacturers the access to the European internal market remains ensured.
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