September 26 this year Katarzyna Wesolowska, President of MDR Regulator, co-hosted a webinar organized by SNITEM (French medical devices association) in cooperation with Valians International entitled: “Medical sector in 2023: Market description, main opportunities in Poland and regulatory aspects”.
The meeting was attended by more than 130 representatives of companies from France. – We see a very high interest of foreign companies in topics related to the registration of medical devices on the Polish market. Of key importance here are the changes in Polish legislation, i.e. the Law on Medical Devices, which introduced additional regulations related to: clinical trials, advertising, list of distributors, as well as information provided with medical devices,” says Katarzyna Wesołowska.
During the webinar, many interesting questions were raised. Attendees discussed how clinical trials are conducted in Poland, what are the registration opportunities and transition periods, as well as many other topics.
In addition, Katarzyna Wesołowska focused on providing a regulatory perspective on the current regulations (MDR and IVDR), additional requirements in the Polish Medical Devices Act and the reimbursement process.