A major issue for healthcare providers is the application of Article 5(5) of the IVDR. The issue is that in many cases clinical...

We can infer where the medical device market will go in 2024 from the previous year's news. At least partially. The year 2023 would...

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...

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...

When discussing medical device regulation, it is often said that Class I and IIa devices do not need to be accompanied by instructions...

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...

For a long time, nothing has been heard about the consultation process for clinical investigation of high-risk devices. As a reminder,...

There is a growing tendency in the field of medical device to shift responsibilities from the manufacturer to the rest of the...