{"id":1115,"date":"2019-09-03T13:40:37","date_gmt":"2019-09-03T11:40:37","guid":{"rendered":"https:\/\/unmz-wp.e-bs.cz\/?page_id=1115"},"modified":"2022-03-31T11:03:15","modified_gmt":"2022-03-31T09:03:15","slug":"medical-medical-media","status":"publish","type":"page","link":"https:\/\/unmz.gov.cz\/en\/statni-zkusebnictvi\/stanovene-vyrobky\/zdravotnicke-prostredky\/","title":{"rendered":"Medical devices."},"content":{"rendered":"

Conformity assessment of medical devices, including active implantable medical devices (hereinafter referred to as \"IMDs\"), is based on compliance with the requirements of the Regulation (EU) 2017\/745 of the European Parliament and of the Council<\/strong><\/a>\u00a0(\"MDR\") 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.<\/p>\n

The MDR replaces the previous Council Directive 93\/42\/EEC on medical devices.<\/p>\n

Act No. 89\/2021 Coll., on medical devices and amending Act No. 378\/2007 Coll., on pharmaceuticals and on amendments to certain related acts (Act on pharmaceuticals), as amended, Act No. 90\/2016 Coll., has been adapted to the MDR Regulation, Act No. 186\/2021 Coll., on the implementation of certain provisions of the Act on Medical Devices, Act No. 170\/2021 Coll., on the determination of the amount of reimbursement of expenses for professional acts performed by the State Institute for Drug Control pursuant to the Act on Medical Devices<\/p>\n

Unlike the previous Directive (93\/42\/EEC), the new Regulation is aligned with the principles of\u00a0the new legislative framework<\/a><\/strong> (NLF), requirements regarding economic operators, notified bodies, registration of devices, conformity assessment procedures, post-market monitoring, clinical trial obligations, etc. have been clarified. There have also been minor changes to the classification rules and some devices may therefore fall into a different risk class than under Directive 93\/42\/EEC. Annex XVI has also been added to define products that have no intended medical purpose but fall under the MDR. Thus, for example, non-prescription coloured contact lenses, subdermal implants, dermal fillers, liposuction devices, IPL epilators, transcranial (non-surgically invasive) stimulation and others are now covered by the Regulation. \"The 'General Safety and Efficacy Requirements' are set out in Annex I of the MDR.<\/p>\n

On the European Commission's FP website\u00a0https:\/\/ec.europa.eu\/health\/md_sector\/new_regulations\/guidance_en#sec3\u00a0<\/a>several documents are published to help navigate the changes related to the implementation of the new MDR and to comply with the MDR requirements<\/p>\n

Overview of notified bodies in the Czech Republic for the MDR Regulation <\/strong><\/p>\n

European Union<\/strong><\/p>\n