Authorised Representatives
What makes Switzerland significant for Medical Device Manufacturers?
Switzerland is a premier destination for medical device manufacturers relying on sophisticated micromanufacturing or advanced precision techniques. This appeal is evident in Switzerland's choice of EMEA headquarters for industry leaders. The country boasts one of the...
Nomenclature of Medical Devices
‘Medical devices’ is an umbrella term that includes products for the prevention, diagnosis, and treatment of numerous diseases. Medical devices require an internationally accepted naming to identify the various types and categories. Nomenclature of medical devices helps understand the medical device’s risk class, definition, and use.
Labelling Requirements – Swiss Authorized Representative
Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of...
Swiss Manufacturer Obligations
1. Manufacturers outside Switzerland will need to appoint Swiss AR. 2. The Manufacturer will use commercially reasonable efforts to update its technical documentation for the devices, to comply with the requirements of the ordinance, and to complete a conformity...
Switzerland AR Responsibilities
Obligations of the Switzerland AR Responsibilities 1. Verify the DoC and technical documentation have been drawn up and where necessary conformity assessment procedure has been carried out. 2. Keep available a copy of the technical documentation, the declaration of...
Swiss Regulation QA WHITE PAPER
MEDICAL DEVICE REGULATION UPDATE IN SWITZERLAND 1. Who is responsible for medical device regulation in Switzerland? The Swiss Agency regulates medical devices for Therapeutic Products (Swiss medic) 2. Which current Switzerland medical device regulations need to be...
Switzerland Medical Device Regulations
Switzerland Market Situation As the Institutional Agreement is missing (InstA) is missing, the EU has not updated the Mutual Recognition Agreement (MRA) No barrier-free access to the EU internal market Swiss has been downgraded to the third country Swiss manufacturers...
Switzerland Authorised Representative
Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturer Responsibility Ensuring medical devices are placed on the market is in accordance with the requirement of the medical device ordinance. Affixing the conformity mark and carrying...