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Medical devices. Group of oxygene ventilators.

Changes in MDCG guidance – borderline products: medical devices & medicinal products

On October 29, the Medical Device Coordination Group (MDCG) published an updated guidance document, "MDCG 2022 – 5 Rev. 1," which provides essential u...

Agnieszka Czajkowska

MHRA: Changes in Post-Market Surveillance of medical devices

The UK government is set to introduce new, strengthened Post-Market Surveillance (PMS) requirements for medical devices, emphasizing patient safety an...

Papers on table showing reports

MedTech Europe Report 2024: Insights into Europe’s Medical Technology Sector and Poland’s Role

In July 2024, MedTech Europe released its highly anticipated "Facts & Figures 2024" report. This comprehensive document provides in-depth insights int...

Invitro process

Transitional provisions for the certification of Class D in vitro diagnostic (IVD) medical devices under the IVDR

The document MDCG 2021-4 Rev. 1, published by the Medical Device Coordination Group (MDCG), provides detailed guidelines on the transitional provision...

Changes in Code of Conduct for Notified Bodies according to MDR and IVDR – harmonization of activities in the EU

Team NB has released an updated version of the Code of Conduct for Notified Bodies, introducing key changes in line with current EU regulations on med...

Katarzyna Wesołowska Vice President of the Board
European Union Flag

European Commission published Notified Body list of standard fees for MDR and IVDR related services

In accordance with Article 50 of Regulation (EU) 2017/745 on medical devices and Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical...

Adrianna Pyrzanowska Regulatory Affairs Associate
Asian scientist looking at a microscopic sample of experimental cyan is doing an in vitro vaccine experiment in a science lab

You can give your feedback to EC about the draft of Common Specification for highest risk in vitro diagnostic medical devices!

Primary responsibility for implementing EU law lies with EU countries. However, some important areas like health the Commission adopts an implementing...

Katarzyna Wesołowska

MDR Regulator Joins the AI in Health Coalition as a Supporting Member

We are excited to announce that MDR Regulator has joined the AI in Health Coalition as a supporting member! Our involvement in this coalition signifie...

Katarzyna Wesołowska Vice President of the Board

Webinar “Innovative Medical Technologies” Recap!

On July 16th, an exceptional webinar organized by Izba Polmed and our partners: MedTech Polska, AI w Zdrowiu, MDR Regulator, and Pure Clinical took pl...

Katarzyna Wesołowska Vice President of the Board