TuV SUD Denmark becomes the 45th Notified Body to be designated under the MDR, and is the first from Denmark. This compares with there now being 12 Notified Bodies designated under the IVDR. The announcement for TuV SUD Denmark follows a few weeks after a second Swedish Notified Body was designated under the MDR, this…
The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is the first time the Commission has proposed updating the guidelines since they were released in 2019. The proposed update was published on 21 March 2024 by the Commission and its Scientific…
The European Commission has recently published its annual report on devices subject to the clinical evaluation consultation procedure (CECP), available from here. Titled ‘Commission Staff Working Document: Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices (July 2022-June 2023)’, the report identifies…
MDCG has published its updated schedule for MDR/IVDR guidance documents, revealing that more than 50 are scheduled to be released before the end of 2024. Copies are available from this web address.
The International Medical Device Regulators Forum (IMDRF) has now released the ‘Outcome Statement’ from its latest meeting, held 11-15 March 2024 in Washington DC, USA. Copies of the report are available from here, which include a note of the decisions made by the ‘regulators only’ closed session, during which eight revised guidance documents were approved…
The US Food and Drug Administration (FDA) has outlined a standardized approach for collecting and reporting on race and ethnicity data in clinical trials and studies in a new draft guidance document. “Using standardized terminology for race and ethnicity helps ensure that data are collected and reporting consistently in submission to FDA,” the agency wrote…
At the MDCG Subgroup on Standards (WG 2) held on 19 January 2024, it was confirmed that for all industrial sectors, the accepted symbol for ‘Authorised Representative’ would change from ‘EC¦REP’ to ‘EU¦REP’. It has been proposed that a two-year transition period would be allowed for product labeling to be brought into line with the…
Misuse of medical devices at home is the most pressing health technology safety hazard, nonprofit patient safety organization ECRI reports. ECRI’s list of the top 10 safety hazards related to medical technology also includes concerns about AI and data security. Since 2008, ECRI has issued its list of the top 10 safety hazards related to…
The US Food and Drug Administration (FDA) has published its long-awaited Quality Management System Regulation (QMSR) final rule that harmonizes its requirements with the International Organization for Standardization (ISO) standard ISO 13485. The agency said the rule will ensure consistency in regulatory expectations for device makers across regulatory regimes, while saving industry hundreds of millions…
The European Commission has proposed to accelerate the timeline for complying with EUDAMED requirements by making the use of finalized modules mandatory on a gradual basis. Under the current regulations, EUDAMED will not become mandatory until all six of its modules are in place; however, under the proposed revisions, EUDAMED compliance would be rolled out…
