Blog

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
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
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 Vice President of the Board

Webinar Announcement: Financing Conformity Assessment for Medical Devices

On June 13th (Thursday) at 12:00 PM, we invite you to a free industry webinar with consultations, organized together with Frontline Biosciences S.A...

Katarzyna Wesołowska Vice President of the Board

Participation in the International Clinical Trials Day Conference

Yesterday, our colleagues Katarzyna Szatraj, PhD and Ilona Korczak-Cegielska attended a very interesting conference on the occasion of International C...