There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…
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TOPRA, The Organisation for Professionals in Regulatory Affairs, host a variety of training in the regulatory space that may be beneficial to BIVDA members. To encourage continued development of regulatory knowledge, we are partnering with TOPRA to offer a discount for BIVDA member organisations. A number of courses are planned this year, with a number involving BIVDA engagement: Regulation of…
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If you attended the BIVDA Spring Regulatory Seminar on 8 March, you are eligible for a CPD certificate. If you would like to receive a certificate for your CPD log, please contact Natalie to request one (natalie@bivda.org.uk).
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The Seminar covered the following topics: MHRA Software Roadmap with Johan Ordish (MHRA) MHRA IVD Roadmap, UKCA, and the Life Science Review with Ashleigh Batchen (BIVDA), Tom Beale (Agilent Technologies) and Camilla Fleetcroft MDCG Roadmap with Andrew Rutter (QuidelOrtho) Class D IVDs with Erica Conway (MCRA) BSI Standards with Rob Turpin (BSI) US Regulatory Process Stuart Angell (IVDeology) The event…
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