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Ben Kemp

Membership NewsMembership News Archive

Nominations for new BIVDA board members closed, candidates announced shortly

The nominations for candidates to be new BIVDA board members has now closed, with candidates to be announced shortly. This year there will six places available for election, who can be from either Full or Associate Member companies, voted for by our members. We will circulate a form shortly where members are able to vote for their preferred candidates. Please note,…
Ben Kemp
February 24, 2025
Membership NewsMembership News Archive

NICE joins international collaboration on HTA methods research

NICE have partnered with the USA-based Institute for Clinical and Economic Review (ICER) and the Canadian Drug Agency (CDA-AMC) to establish the Health Economics Methods Advisory (HEMA), a new international initiative to research and assess health technology assessment (HTA) methods. HEMA’s aim is to critically and independently research some of the most pressing topics in global health economics and health…
Ben Kemp
February 24, 2025
HighlightsHighlights Archive

Survey finds genetic testing to tailor medication use overwhelmingly supported by patients

New research shows almost 90% of people in England would agree to genetic testing to get the most effective medication and reduce the risk of side effects. Other statistics further confirm the overwhelming support of pharmacogenomic testing amongst the public. 85% thought that the NHS should offer pharmacogenomic testing to people with multiple health conditions. 58% of people thought that…
Ben Kemp
February 24, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

How to prepare for the new Post-market Surveillance Requirements in Great Britain

25 March 2025 | 09:00 and 16:00 GMT Join us for our PMS in Great Britain webinar on 25 March 2025 This insightful webinar will introduce the PMS requirements under the new regulations in Great Britain for Post-market Surveillance. Our speakers will provide an overview of the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR. In addition, an update/…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Join the RAPS Workshop: Cybersecurity for Medical Devices 

Cybersecurity remains a top priority for medical device manufacturers   Cybersecurity Unauthorized Attend from anywhere: 25 – 26 March 2025, 9 am - 5 pm ET   This interactive virtual workshop will provide crucial insights into navigating global cybersecurity regulations and developing effective strategies to strengthen your submissions and compliance processes.   After completing this two-day workshop, you will be…
Ben Kemp
February 21, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveRegulatory Affairs Working Party Archive

MDCG – 2019-6 Rev 5 Q&A: Requirements relating to notified bodies

EU MDCG have published the 5th Revision of the Q&A: : Requirements relating to notified bodies – MDCG 2019-6 Rev 5 Although applicable to EU Notified bodies, it is useful to see what the EU Competent authorities are asking notified bodies to require, and allows companies to prepare supporting evidence accordingly. The latest update includes improved content on structured dialogue,…
Ben Kemp
February 21, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Joint MedTech Europe/COCIR Reflection Paper on MDSAP

MedTech Europe and COCIR have jointly published their position paper asking for the UE to join as a full member of MDSAP (Medical Device Single Audit Program). This aligns with our own position that the UK should also join, and make MDSAP optional alongside the current ISO 13485 Certification program regarding Quality Management Systems certification. You can read it here.
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 16 Feb)

MHRA Real-World Evidence Scientific Dialogue Programme Page summary: A programme to help decision-making across the lifecycle of products, benefitting both regulatory and health technology assessment (HTA) evaluations. Change made: Changed to add download link to Expression of Interest for the MHRA Real-World Evidence Scientific Dialogue Programme pilot Time updated: 12:01am, 10 February 2025     Digital mental health technology: qualification…
Ben Kemp
February 21, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 16 Feb)

Visiting the UK as an EU, EEA or Swiss citizen Page summary: What you need to know about crossing the UK border and visiting the UK. Change made: Added details about who will need an electronic travel authorisation (ETA) from 2 April 2025, and who will not need an ETA. Time updated: 2:47pm, 10 February 2025
Ben Kemp
February 21, 2025
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