MDR

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.

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....

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...

Do hospitals really want to produce in-house devices according to the MDR?

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

Here comes 2024: What is on the horizon?

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...

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...

Critical Areas for Transition from MDD to MDR (updated)

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...

English commentary on MDR release is planned for autumn, followed by a commentary on IVDR

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

New survey on the capacity and experience of notified bodies

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

Instructions for use - software and sterile devices

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