Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

New Regulation of Medical Devices in Switzerland

Dr. Esrin Rasmussen (Abschlußjahr: 2022)

Summary
Language: English
Many new requirements have arisen with the entry into force of the revised Swiss MedDO in May 2021, which is based on the European MDR. New tasks have appeared both for Swiss companies and for European companies that have places of business in Switzerland. Manufacturers and other companies that import medical devices from third countries, which includes Europe since the failure of the MRA update, must register with Swissmedic as importers, require a Swiss authorised representative and a PRRC. Together with the new European based stipulations, these mentioned additional requirements have created immense challenges for companies in Switzerland that import medical devices and where the headquarters are based in Europe.
In general, the economic operators (manufacturer of the medical devices, importer, authorised representative, supplier) and the PRRC must register with Swissmedic and each function receives its own CHRN.
In the end, all Swiss companies, regardless of whether they import medical devices or market only those, they manufactured in Switzerland or do both, they have to comply with many requirements covering many areas. This thesis considered those new obligations that have arisen in vigilance and post-market surveillance, where providing of PSURs and trend reporting have now become mandatory; and labelling where the packages have to be provided with additional information, such as the authorised representative and the UDI.
The high requirements and obligations have contributed to the fact that many importers of medical devices have been challenged to many decisions. With the number of products companies have in their portfolio, there is more work to be done by the companies and their employees. Companies have had to weigh up whether to remove medical devices from their portfolio or to hire new employees who can perform the new tasks.
Pages: 65
Annexes: 02, Pages: 04