As the European and overall worldwide regulation strives to become clearer, unambiguous, harmonised and as a result, more restrictive and demanding, this tendency still seems to leave behind the post-marketing studies for medical devices.

The European Union Medical Device Regulations 2017/745 entered into force in May 2021 and significantly improved the clarity about the expectations imposed on manufacturers in the post-marketing period.

The MDR’s increased requirements for clinical evaluation aim to ensure safer medical devices for consumers and users. However, this in parallel, leads manufacturers to new challenges related to the preparation of robust Clinical Evaluation Reports for their medical devices.

The possibility of some undesired consequences for the European market is a highly discussed topic, as for some manufacturers, the cost of generating the required clinical data will outweigh the potential return on investment. Consequently, the manufacturers may discontinue certain medical devices or remove them from the EU market, leading to a device shortage.