The European Commission has launched a review of the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The aim is to reduce the administrative and financial burden, which in practice mainly affects smaller manufacturers and hinders innovation. The Czech Republic actively participated in the consultations and sent its comments and suggestions for improvement to Brussels.

March 2 is approaching, bringing with it the obligation to review and confirm their data in the ISZP system.

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

The application of the principle of equivalence to the clinical evaluation of medical devices is particularly challenging.

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.

The use of clinical data of a "similar" medical device based on the principle of equivalence is highly problematic.

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...