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...
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 Board Member
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
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...
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
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
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...
