MedTech Market Access Insight
MDR Regulator
Medical Devices ?? In vitro diagnostic medical devices ?? Personal protective equipment (PPE) ?? Certification process
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 act. As part of the Commission's better regulation agenda, citizens and other stakeholders can provide feedback on the draft text of an implementing act for Common Specifications of IVDs for 4 weeks before the relevant committee votes to accept or reject it (till 16th of September).
The US FDA updated the list of AI/ML-Enabled Medical Devices, authorizing 950 devices
The US Food and Drug Administration (FDA) updated list of of authorised AI/ML-Enabled Medical Devices. This marks a significant 37% increase from last year (692 devices). The majority of the approved devices (750 out of 950) are designated for radiology, with cardiology following at 98 devices and neurology at 34. The FDA emphasizes that the list isn't exhaustive but covers AI/ML devices across medical disciplines based on marketing authorization document summaries.
European Commision 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 devices, notified bodies establish lists of their standard fees for the conformity assessment activities that they carry out and make those lists publicly available.
What's new in our group?
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 signifies our commitment to advancing the integration of artificial intelligence in healthcare. We look forward to collaborating with other industry leaders to drive innovation and improve patient outcomes.
Postgraduate program in collaboration with TUV NORD Polska and the Politechnika Bia?ostocka
We are thrilled to announce that MDR Regulator and Pure Clinical are proud partners of a new postgraduate program in collaboration with TUV NORD Polska and the Politechnika Bia?ostocka. This specialized course, focused on the certification and market introduction of medical devices, is designed for professionals eager to advance their careers in the medical industry.
Upcoming Events
Conference of the Polish Society for Biomaterials
10-13.10.2024 Rytro
The Conferences on Biomaterials in Medicine and Veterinary Medicine are held every year and address both fundamentals and clinical applications of carbon, metals, polymers, ceramics and composite biomaterials. Their aim is to present the latest results of scientific research as well as to exchange ideas, knowledge and experience of scientists, researchers and clinicians in the field of biomaterials.
Attenders:
Adam Sobantka
International Conference Clinical Research is WE!
10-11.10.2024 Warsaw
One of the main topics will be an update to the GCP ICH E6 (R3) guidelines, which introduce a number of new rules for quality management and decentralization of clinical trials. These changes are designed to improve the flexibility and efficiency of research while ensuring the highest ethical and scientific standards.
Attenders:
Katarzyna Weso?owska
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Regulatory Affairs | Clinical Trials | Laboratory Testing