In the light of the anticipated go-live of most of the European database on medical devices (EUDAMED) modules in 2025, MedTech Europe has summarised in a position paper its viewpoint on ensuring a smooth transition to its mandatory use, in which it calls for improved accessibility, efficiency and consistency through technical and regulatory measures in…
ECRI has issued it ‘Top Ten Health Technology Hazards Report’ for 2025, available from here. The report identifies potential sources of danger involving the use of medical devices and systems. Further, the report offers practical recommendations for reducing the identified risks, all with the goal of preventing harm. The List for 2025 is: 1. Risks…
The US Food and Drug Administration (FDA) has issued a much-anticipated final guidance document detailing how it plans to regulate changes to artificial intelligence (AI) enabled medical devices post authorization by using pre-determined change control plans (PCCPs), allowing manufacturers to update AI-enabled devices without filing an additional submission to the Agency. The document is titled…
One day after the European medtech industry proposed short and medium term actions needed to support public health, patient safety, and the future sustainability of Europe’s health systems, concluding that “broad and comprehensive reforms” were needed, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) meeting discussed similar measures proposed by several member states,…
The European Commission has published a Q&A on the obligation to inform about supply interruptions or discontinuations for specific devices, as required under the new Article 10a of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746). This obligation, introduced by Regulation (EU) 2024/1860, affects manufacturers by mandating notification…
The European Parliament has adopted a resolution to update the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to avoid potential product shortages in the region, sketching out a timeline for when such changes will be proposed. The move comes as manufacturers have continued to voice concerns about the ability to meet deadlines…
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…
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…
