The new regulations for medical devices in the European Union, implemented through Regulation (EU) 2017/745, introduce significant changes that aim to enhance product quality, safety, and traceability. These changes impact various aspects of the medical device industry, affecting manufacturers, importers, distributors, and other market participants. Notable modifications include the introduction of unique identification codes (UDI) for devices, stricter conformity assessment procedures, and an electronic database called Eudamed for improved information exchange. The regulations also redefine classification rules, resulting in some devices being assigned to higher classes, necessitating compliance with higher quality requirements. The new Polish Medical Devices Law, implemented in alignment with the EU Regulation, clarifies obligations, administrative penalties, clinical trial procedures, and advertising regulations. Polish companies can smoothly adapt to the new requirements by considering outsourcing certain tasks, such as compliance evaluation, technical documentation preparation, market surveillance planning, and employee training. Overall, the changes emphasize the industry's commitment to enhancing safety standards for medical devices.
The regulation for medical devices in the European Union has been relatively unchanged since the 1990s, but as of May 26, 2021, the deadline for the application for new medical devices changed and extensive legal modifications resulting from Regulation (EU) 2017/745 of the European Parliament and of the Council occurred, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (i.e., the so-called MDR - Medical Devices Resolution or Regulation) of April 5, 2017 on medical devices, which also occurred in Poland with the Law of April 7, 2022.