Find out here what is meant by specialists in this context and what they have to bear in mind when procuring foreign medical devices.
Find out here what is meant by specialists in this context and what they have to bear in mind when procuring foreign medical devices.
Provisions of the MepV
The Swiss Medical Devices Ordinance (MepV) serves to align Swiss law with the European Medical Devices Regulation (MDR) and enables professionals to procure foreign CE-marked medical devices directly abroad and use them nationally. This means that no national testing, registration and documentation requirements apply when sourcing abroad.
In Switzerland, there are significant deficits in the supply of medical devices, which are caused by the existing regulatory system, according to a study. One regulatory challenge, for example, is the new European Medical Device Regulation (MDR), which introduces a wide range of regulations for the approval and sale of medical products. Switzerland’s high dependence on foreign suppliers for medical products is another reason for the supply deficits.
Placing on the market medical devices
The Swiss Medical Devices Ordinance (MPV) allows professionals to procure medical devices abroad and use them nationally without the need to place them on the market in Switzerland.
But what exactly is meant by this type of procurement by professionals?
Professionals can procure foreign CE-marked medical devices directly abroad and use them nationally without this resulting in a placing on the market in Switzerland. Procurement activities can be carried out by the professionals themselves, or delegated to third parties. However, they bear a great responsibility in doing so, as they must ensure that the procured products comply with the requirements of the MDR.
Professionals can procure medical devices abroad and use them nationally without having to place them on the market in Switzerland.
Continuity of supply
The responsibility of the professionals also relates to the documentation of the procurement processes as well as to the monitoring and tracking of the products to ensure continuity of supply. To minimize potential impacts on supply continuity, professionals sourcing medical devices abroad should carefully check that the products meet MDR requirements and that suppliers are reliable and certified.
Legal requirements
Overall, sourcing CE-marked medical devices abroad is a way for professionals to meet their needs and avoid supply shortages. However, it is important that professionals comply with the legal requirements and fulfill their responsibilities to ensure the safety and efficacy of the procured products. Failure to comply with legal requirements can result in consequences such as liability suits or restrictions on product approvals.
Support direct procurement
Do you need support with the direct import of CE-marked products or are you looking for a competent partner for the distribution of your brand in Switzerland? Through the distribution and marketing of our own brands, we can look back on many years of experience in sales and marketing. We are happy to pass on this experience to you.
If you have any questions, please feel free to contact us by phone or e-mail or simply fill out our contact form.
