The EU now has its 50th Notified Body under the Medical Device Regulations, NEOEMKI in Hungary, following the designation of the 49th, the Istituto Superiore di Sanita (ISS) in Italy being designated under the IVDR in September. NEOEMKI (Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság), based in Budapest, is the second designated under…
Perhaps the answer lies in the latest edition of TEAM-NB’s Code of Conduct which devotes a section to ‘structured dialogue’ for the first time, following the MDCG’s inclusion of the term in guidance documents MDCG 2022-14 and MDCG 2022-11 Rev. 1. As a reminder: MDCG 2022-11 Rev.1 states: “A proper assistance to manufacturers with regulatory…
Donawa Lifescience President, Maria E. Donawa, M.D., has authored a second ‘Regulatory Recap’ article on LinkedIn covering interpretational difficulties with requirements for Clinical Evaluation Plans (CEPs) under the EU Medical Device Regulation (MDR, 2017/745) titled: ‘CEPs: What Does “State of the Art” Modify?’ The topic arises because of confusion among manufacturers, notified bodies, and competent…
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published the user fees applicable to submissions, etc for fiscal year 2025, running from 1 October 2024 to 30 September 2025. The new fees represent a 12% increase over the 2024 fees. Further details are available from the FDA website….
The European Commission has published the final text of the Artificial Intelligence Act (AIA) which establishes a legal framework for “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing such products on the Community market. The AIA was published in…
The Competent Authorities for Medical Devices (CAMD) and the Heads of Medicines Agencies (HMA) have published a joint statement on the current status of the EU regulatory system for medical devices and in vitro medical devices. The statement, copy available from here, makes it clear that “there are challenges in applying the Regulations for all…
Regulation (EU) 2024/1860 includes changes to the device regulations in the areas of Eudamed roll-out, interruption of device supply, and transitional provisions for certain IVDs. The regulation (and it’s almost immediate corrigendum) were mentioned in a press release from the Council of the European Union published on 30 May 2024, which identified that the regulation…
The US Food and Drug Administration (FDA) has proposed a draft guidance that would give medical device manufacturers more leeway in responding to misinformation about their products. The guidance comes as the agency has spent the past few years trying to dispel COVID-era misinformation that may have caused thousands of deaths. On 8 July 2024,…
The following new guidance documents for device manufacturers placing devices on the European market have been published in recent weeks: MDCG 2024-1-5: Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence MDCG 2022-13 Rev.1: Designation, re-assessment and notification of conformity assessment bodies and notified bodies MDCG 2024-10: Clinical evaluation of…
The US Food and Drug Administration (FDA) has recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials. The draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” includes suggestions for companies and researchers conducting trials on how to…
