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Ben Kemp

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Mpox declared a public health emergency by WHO

The World Health Organisation (WHO) have declared a public health emergency of international concern (PHEIC) following a rise in mpox cases in the Democratic Republic of the Congo (DRC) and a growing number of other African countries. The declaration follows advice of an IHR Emergency Committee of independent experts who met last week to review data presented from the WHO…
Ben Kemp
August 20, 2024
Membership NewsMembership News Archive

Health Secretary commends BIVDA’s work to tackle NHS challenges

Health and Social Care Secretary Wes Streeting responded to BIVDA's letter welcoming him to his role following last month's general election by recognising BIVDA's ongoing work. Mr Streeting called out our engagement with the MedTech and Innovation Directorate to tackle NHS challenges and welcomes BIVDA's ability to support his department's continued engagement with industry. He was eager to stress the…
Ben Kemp
August 20, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO consults on collaborative registration procedures guideline

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 Kemp
August 14, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

(EU) 2024/2120 published

"(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 Kemp
August 14, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

17 Oct deadline for member states to implement EU Directive 2022/2555

17th October 2024 is the deadline for EU member states to implement the EU Directive 2022/2555 EUR-Lex - 02022L2555-20221227 - EN - EUR-Lex (europa.eu) on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) 910/214 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). NIS 2 widens the scope of services covered…
Ben Kemp
August 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 12 Aug)

Notify MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: New section ‘Regulatory advice meetings’ added to this page. Time updated: 11:45am, 5 August 2024 Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of…
Ben Kemp
August 14, 2024
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