With the transition from MDD to MDR and IVDD to IVDR, manufacturers of medical devices face a number of challenges. One of the most...

We have prepared an overview of the areas we consider CRITICAL in preparing for the transition from MDD to MDR. The selection is based on...

Porta Medica, in cooperation with the Czech Agency for Standardization, published in 2022 both a book (printed) and an electronic version...

On 25 July 2023, the European Commission published a Notified Bodies Survey on certifications and applications (MDR/IVDR). The data...

On Monday 19 June 2023, another meeting of the platform at the Ministry of Health took place, where representatives of regulators, health...