The Swiss Federal Council, has request that Swiss law be updated to reflect the EU IVDR Transition timelines, to avoid loss of devices from the Swiss market. You can read more here.
Ben KempAugust 21, 2024
Thursday 14th November - SEC Arena, Glasgow Join for a full day conference on the 14th November from 9am until 5pm. They will be bringing to you educational presentations, interactive discussion sessions and a product fair from a wealth of Point of Care manufacturers. Industry delegates are welcome to join and the registration fee is £125.40 including VAT. Please ensure…
Ben KempAugust 21, 2024
This study reveals cyber vulnerabilities in the EU healthcare sector and further highlights the challenge of characterising cyber incidents in regard to their health consequences. Hurdles are a lack of consistent evaluation and reporting criteria and a lack of frameworks for assessing causality. We alert that such tools need to be developed in order to prepare for the rising risk…
Ben KempAugust 21, 2024
Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: Added the following to the ‘List of medical devices given exceptional use authorisations’:Dolphin Fluid Immersion Simulation SystemAxiomTM Total Blood Typing Solution/Gene Titan™ Multi-Channel…
Ben KempAugust 20, 2024
Please see the EU Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law. Note that that the UK is a Council of Europe member state.
Ben KempAugust 20, 2024
FDA have updated their classification codes for devices intended: To detect and identify nucleic acid targets including SARS-CoV-2 in respiratory specimens (Class II with special controls), To detect and identify selected microbial agents that cause acute febrile illness (Class II with special controls)
Ben KempAugust 20, 2024
The World Health Organization (WHO) has released a draft version of its updated guideline on practices for national regulatory authorities’ (NRAs) implementation of collaborative registration procedures (CRP) to facilitate the marketing authorization of new medical products within their jurisdictions for products that have either been WHO-prequalified or approved by a stringent regulatory authority. Read more here.
Ben KempAugust 14, 2024
"(EU) 2024/2120 - renewing the designation of issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices" published. This reestablishes the following four entities as UDI issuing entities. GSI HIBCC ICCBBA IFA
Ben KempAugust 14, 2024