The most important legal regulations of medical devices

The purpose of the legal regulations for medical devices in force in Poland and Europe is to ensure that only those devices that meet the highest standards are placed on the market – and thus ultimately in the hands of patients and medical professionals. The regulations were created to ensure that products placed on the market are properly controlled – therefore, the requirements regarding clinical trials of products and the presence of units responsible for control during the process of contract manufacturing of medicines must be met.

What is a medical device?

What is a medical device? According to Art. 2 MDR, a medical device is an article intended by the manufacturer to be used for human beings for specific medical purposes, such as:

• diagnosis, prevention, monitoring, treatment, or alleviation of disease;
• diagnosis, prevention, monitoring, treatment, alleviation, or compensation for an injury or disability;
• investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state;
• control of conception.

Importantly, a medical device does not achieve its principal intended action by pharmacological, immunological, or metabolic means in or on the human body, but it may be assisted in its function by such means.

What important elements of the production and distribution of medical devices are regulated by the currently applicable documents?

• implementation of an appropriate product conformity assessment procedure,
• the need to draw up an EU declaration of conformity
• obligation to obtain a certificate of conformity before placing the product on the market,
• the issue of placing the CE mark on the product,
• other activities directly related to ensuring the safety of the use of medical devices by patients and healthcare professionals.

Legal regulations for medical devices can be divided, among others, according to the sources of legal acts. These are:

• European Union regulations
• Regulations of the Republic of Poland

Regulations on medical devices in Poland – Polish law

Until now, the most important Polish documents regulating the production and distribution of medical devices were the Act of 20 May 2010 on medical devices, but 2022 brought very important changes in the legal regulations concerning medical devices in Poland. Currently, the key is:

• Act of 7 April 2022 on medical devices (Journal of Laws of 2022, item 974).

Important: The Act of 7 April 2022 entered into force on 26.05.2022 and is a completely new legal act. It was created as part of a government bill on medical devices, which was aimed at implementing European Union law – in particular, adapting Polish law to the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, which entered into force on 26 May 2021. All information about the latest act can be found on the website of the Journal of Laws: Journal of Laws of 2022, item 974. A full list of documents related to the legal regulations for medical devices is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in the Polish Regulations tab.

The most important European legal regulations for medical devices

The most important documents issued by the European Union – also indirectly regulating Polish law – include:

• 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 L 117, 5.5.2017, p. 1, OJ L 117, 3.5.2019, p. 9, OJ L 334, 27.12.2019, p. 165, OJ L 130, 24.4.2020, p. 18 and OJ L 241, 8.7.2021, p. 7);
• 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 L 117, 5.5.2017, p. 176, OJ L 117, 3.5.2019, p. 11, OJ L 334, 27.12.2019, p. 167 and OJ L 233, 1.7.2021, p. 9);
• Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

A full list of EU legal acts regulating the production and distribution of medical devices is available on the URPL website in the EU Regulations tab.

Learn more about the production of medicines and supplements, their safe use, and related legal regulations from other articles published on our blog! We encourage you to read the entry Production of dietary supplements and consumer safety.