2021/0698/PL
EC/EFTA
PL Polen
  • S10S - Medizinprodukte
2022-02-07
2021-11-12

1. Medical devices, active implantable medical devices and accessories for medical devices and implantable medical devices regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, 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 (OJ EU L 117, 5.5.2017, p. 1, as amended)

2. In vitro diagnostic medical devices and accessories for in vitro diagnostic medical devices regulated by Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ EU L 117, 5.5.2017, p. 176, as amended)

Medical Devices Act

The Medical Devices Act comprehensively regulates issues related to medical devices and medical devices for in vitro diagnostics. The Act sets out, inter alia,

obligations of economic operators, public health institutions, medical practitioners, medical professionals and other entities in connection with the marketing and use of medical devices, their use, reporting of medical incidents. It also specifies the competence, powers, responsibilities and tasks of the authorities, including the types of decisions to be taken, as well as the administrative penalties (including their amount). The document regulates the rules and procedures for carrying out the clinical investigation of a medical device and the performance study of an in vitro diagnostic medical device. Another area governed by the Act is the amount and method of payment of fees, rules of use and maintenance of products, including their servicing. A separate chapter regulates the rules and procedures for carrying out inspections of a clinical investigation of a medical device and an inspection of the performance study of an in vitro diagnostic medical device. One of the areas that the EU regulations left to the Member States was the issue of advertising of medical devices, so the law also refers to the rules on advertising of devices and supervision of advertising. It also regulates all matters relating to the designation of notified bodies involved in conformity assessment procedures for medical devices.