MDR

Oct 7

Transition Guide to the MDR - new free publication

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

Sep 20

AI Act – Significant Change or Substantial Modification?

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.

Sep 12

Equivalent medical device and biological characteristics

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

Apr 7

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.

Apr 1

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....

Mar 19

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...

Mar 14

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...

Jan 8

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...

Jan 8

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...

Sep 17, 2023

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...