The Czech Standardization Agency & Porta Medica published "Transition Guide to the MDR" that explains key changes in the MD regulation.

Certain entities will be subject to new obligations under Regulation (EU) 2023/1115.

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.

We present you with a summary of the newly published Q&A addressing the practical aspects of fulfilling the manufacturer's new obligation.

Amendments to EU regulations will be approved, mandating earlier Eudamed use. Gradual use starts Q4 2025, fully by Q4 2027.

“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g....

In January, the European Commission published a proposal for another amendment to the MDR and IVDR, which brings a number of major new...

On Friday, 19 January 2024, the Ministry of Health held a meeting of the Stakeholder Platform on the issue of medical device regulation....

On 2 February 2024, the Belgian Presidency announced that the representatives of the EU Member States had already agreed on a final...

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...