Blog

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 Board Member
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 Board Member

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 Board Member
Doctor in an abstract image with health icons in circle

Regulation (EU) 2024/1860- the latest changes to MDR and IVDR

On 9 July 2024, regulation (EU) 2024/1860 was published regarding a gradual roll-out of Eudamed, the obligation to inform in case of interruption or d...

Agnieszka Czajkowska Senior Regulatory and Clinical Affairs Consultant
In vitro diagnostic process

MDCG 2020-16 Rev.3- updated IVDR classification guidelines

The Medical Device Coordination Group (MDCG) has published the third version of the MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnos...

Clinical Evaluation of Orphan Medical Devices: New Guidelines

The new guidelines introduced by the European Commission address the clinical evaluation of orphan medical devices under the MDR, recognizing their un...

Guiding Principles for Transparent Machine Learning in Medical Devices

The FDA, Health Canada, and the UK's MHRA have established guiding principles to enhance transparency in machine learning-enabled medical devices (MLM...

Katarzyna Wesołowska Board Member