As is now widely known, as of 26th May 2021, Switzerland became a Third Country for the EU, following Medical Devices Regulatory MDR (EU) 2017/746 full application and in the absence of an institutional agreement between Switzerland and Europe.
The regulatory system for Medical Devices has changed in Switzerland, in particular with the Medical Devices Ordinance MedDO SR 812.213.
As a consequence, EU Manufacturers who wish to market their own Medical Devices in Switzerland are faced with numerous new tasks to be carried out, in compliance with progressive deadlines. In this process of adaptation to the new requirements for Switzerland, it is crucial to follow very specific steps and to make sure that these steps are carried out correctly.
What to do and how to do it best?
Explaining what Thema can do for you, we have drawn up a small guide to help you in the preparation phase for marketing Medical Devices in Switzerland.
1. Swiss Authorised Representative or CH REP Nominee
Medical Devices and IVDs Manufacturers who are not based in Switzerland must appoint a Swiss Authorised Representative or CH REP in order to export their own Medical Devices in Switzerland:
- From 31st December 2021 for class III devices, class IIb implantable devices and implantable active Medical Devices;
- From 31st March 2022 for class IIb non-implantable devices and class IIa devices;
- From 31st July 2022 for class I devices, systems, and procedural packs.
The Swiss Authorised Representative takes care of formal and safety-related issues regarding the device marketing; therefore, they play a regulatory role with important responsibilities.
❌ Be careful! Companies that do not have a registered office in Switzerland or do not meet the requirements cannot provide the CH REP service.
✅ Thema can provide the CH REP service in full compliance with the Regulation.
2. Person Responsible for regulatory Compliance (PRRC) Nominee
The Swiss Authorised Representative has to appoint a person responsible for regulatory compliance within their company namely Person Responsible for regulatory Compliance (PRRC).
❌ Not everyone can play the Role of Person Responsible! Whoever occupy this position, indeed, must have a high school diploma or a degree in one of the following disciplines: law, medicine, pharmacy, engineering, or another scientific-related discipline such as biomedical engineering, biology, chemistry, or biotechnology. Furthermore, the PRRC must be aware of legislative and applicable regulatory aspects, as well as at least one year’s experience in the field if they have a degree, otherwise 4 years of experience.
✅ With Thema’s CH REP service, PRRC’s role is carried out in accordance with the requirements by professionals with all the qualifications and the experience necessary to undertake and supervise CH REP regulatory experience.
Three steps to follow in order to activate the service
Thema’s CH REP service involves the following steps which guarantee full compliance with Swiss regulation:
1. Technical documentation and Quality Management System (QMS) documentation revision.
In this first stage the Manufacturer has to send the technical documentation to Thema experts. Subsequently, a sampling check based on the amount of technical documentation and the type of Medical Devices will be carried out. This control is essential, because it is necessary to ensure that the documentation is adequate, accurate and faultless.
2. Mandate activation for CH REP nominee.
Thema charges an annual fee which does not depend on the number of devices or technical documentations but is dictated by the customers’ highest class of Medical Device.
3. CH REP service post-Mandate activities, in compliance with MedDO articles 51 and 52 and MDR art. 11.
Within 3 months after first placing on the market, Thema as CH REP deals with:
✅ Registering the Manufacturer with Swissmedic.
✅ Registering the Manufacturer’s devices with Swissmedic.
✅ Notifying themselves as CH REP for the reference Manufacturer.
Choose Thema as your CH REP!
You can rely on us!
Thanks to 15 years of experience and to a solid organisational structure, Thema can ensure you compliance with the regulation for accessing the Swiss market.
Thema experts are available to provide you with a reliable, worry-free service performed at the highest level.
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