The field of medical devices and in vitro diagnostic medical devices has witnessed significant legislative changes in recent years. These changes came into effect in 2021 for medical devices and in 2022 for in vitro diagnostic medical devices (IVDs) in the EU. This new legislation completely transformed the perspective on the notification of medical devices and IVDs, introducing new obligations for manufacturers of these devices to demonstrate effectiveness, safety or performance. Simultaneously, the new legislation brought about significant changes related to the creation of documents for the notification process. These new requirements are putting pressure on manufacturers, as all new notifications and renewals of existing notifications require implementing these new procedures.

In an effort to assist manufacturers in preparing notification documents and researching the efficacy, safety or performance of their medical devices and in vitro diagnostic medical devices, MeD Services, in cooperation with its sister organization Prague Clinical Services, has prepared a unique service that fully reflects the requirements of the new European Union regulations - Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).

To ensure the provision of these services at the highest professional level, MeD Services has assembled a specialized team of experts in legislation, writing notification documents, and statistics. This team is capable of preparing the offered services and guaranteeing their accuracy. The results of their work can be documented in prepared notifications and upon their unobjectionable acceptance by the Czech regulatory authority, the State Institute for Drug Control.

MeD Services approaches each project with a highly individualized perspective.