The IBMS, in collaboration with the Royal College of Pathologists (RCPath) and the Association for Clinical Biochemistry and Laboratory Medicine (ACB), has jointly produced a new national guidance on Point of Care Testing. Members are encouraged to review this guidance.
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Recently, BIVDA joined the Joint Trade Association, a collective of Trade Associations in the electronic space. This is in response to ongoing pressure with UK RoHS and the new fee associated with submitting applications of exemption under UK RoHS. We hope that by working with JTA, we will be able to support the BIVDA membership in submitting, or collating, UK…
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BSI have adopted IEC 61010-2-101:2018 as a British standard. BS EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment considers electrical safety requirements for IVD equipment, and should be considered for manufacturers with products in this space.
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UL have made available a 30 minute webinar on the upcoming UK Medical Device Regulation changes. This is a free webinar available from the UL website. It covers current timelines, expected requirements based on the MHRA consultation response, and transitional arrangements.
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A reminder that BSI have put a call out for those interested and knowledgeable in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017). This is to join their committee EPL/66, Safety of measuring, control and laboratory equipment’ in developing the above standard which is undergoing a revision.…
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Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…
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