Medical devices.
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 ("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.
The MDR replaces the previous Council Directive 93/42/EEC on medical devices.
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
Unlike the previous Directive (93/42/EEC), the new Regulation is aligned with the principles of the new legislative framework (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.
On the European Commission's FP website https://ec.europa.eu/health/md_sector/new_regulations/guidance_en#sec3 several documents are published to help navigate the changes related to the implementation of the new MDR and to comply with the MDR requirements
Overview of notified bodies in the Czech Republic for the MDR Regulation
European Union
- European Commission website for FP
- Notified persons in the EU - List of notified bodies for the MDR
- Harmonised standards - harmonised European standards under the MDR
Czech version of relevant EU regulations
32017R0745 Regulation (EU) No 2017/745 of the European Parliament and of the Council
Act No. 89_2021 Coll.
Act No. 90_2016 Coll.
Decree No. 186_2021 Coll.
Decree No. 170_2021 Coll.
According to Article 120 of the MDR, transitional provisions, a device with a valid Declaration of Conformity or a valid certificate issued in accordance with Government Regulations No. 54/2015 Coll. or No. 55/2015 Coll. (Council Directive 93/42/EEC) may be placed on the market until the certificate is valid, but no later than 26 May 2024.
List of entities authorised to carry out conformity assessment activities for medical devices, which from 26. 5. 2021 can only supervise the certificates issued by them: