Reintroduction of national regulation on medical devices

An amendment to the Act on Medicinal Products and Medical Devices reintroducing the national regulation of medical devices entered into force on 23 July 2020. This regulation was originally repealed effective from 26 May 2020, when the EU Medical Devices Regulation was scheduled to enter into force. The EU Medical Devices Regulation was postponed for one year due to COVID-19 pandemic, to which the Slovak legislator did not manage to react in time and, as a result, the medical devices area was without regulation in Slovakia for almost a month.

The provisions regulating definitions in the medical devices area, internet sales, registration and evidence of medical device manufacturers, clinical investigation of medical devices, placing of medical devices on the market and putting into service, procedures in case of wrongly affixed or missing CE marking, measures to protect health and safety of patients, confidentiality, recording ad evidence of accidents, malfunction or deterioration following placing of devices on the market, applying retroactively from 26 May 2020, until 26 May 2011, when the postponed EU Medical Devices Regulation shall enter into force, are included in the transitory provisions of the Act on Medicinal Products and Medical Devices, in Sections 143k to 143t.

With the amendment to the Act on Medicinal Products and Medical Devices, its implementing instruments were newly published and re-entered into force as well: Government Regulation Determining Details on Technical Requirements and Conformity Assessment Procedures for Medical Devices, and Government Regulation Determining Details on Technical Requirements and Conformity Assessment Procedures for Active Implantable Medical Devices.

Should you wish to learn more, please contact our colleagues Marek Holka and Tomáš Rybár.