Transition Guide to the MDR - new free publication
The Czech Standardization Agency & Porta Medica published "Transition Guide to the MDR" that explains key changes in the MD regulation.
top of page
Aleš Martinovský
Sep 20
AI Act – Significant Change or Substantial Modification?
We know very well what a significant change of (medical) devices is in the scope of the MDR since the publication of MDCG 2020-3 Rev1.
Gabriela Charvátová
Apr 8
The official version of the Eudamed database will be launched module by module
Amendments to EU regulations will be approved, mandating earlier Eudamed use. Gradual use starts Q4 2025, fully by Q4 2027.
Gabriela Charvátová
Apr 2
Electronic instructions for use of medical devices: what you need to know
“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g....
Jakub Král
Mar 19
Amendment Regulation updating the MDR and IVDR soon to be adopted
In January, the European Commission published a proposal for another amendment to the MDR and IVDR, which brings a number of major new...
Jakub Král
Feb 16
The Platform of the Ministry of Health addresses comments on the methodology for inclusion of the ZUM in the VZP-ZP Reimbursement Catalogue
On Friday, 19 January 2024, the Ministry of Health held a meeting of the Stakeholder Platform on the issue of medical device regulation....
Aleš Martinovský
Feb 16
European AI regulation agreed
On 2 February 2024, the Belgian Presidency announced that the representatives of the EU Member States had already agreed on a final...
Jakub Král
Jan 8
2023: What happened in the field of medical devices?
The turn of the year is always accompanied by some kind of taking stock of what has happened in the past year. As far as the medical...
Jakub Král
Jul 19, 2023
The Ministry of Health held another meeting on price and reimbursement regulation
On Monday 19 June 2023, another meeting of the platform at the Ministry of Health took place, where representatives of regulators, health...
Veronika Moravová
Mar 31, 2023
The European Commission's document on the new MDR transition periods addresses some contentious issues
On 20 March 2023, Regulation (EU) 2023/607 of the European Parliament and of the Council came into force, amending the MDR and IVDR. The...
bottom of page