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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 13 Mar)

Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
admin
March 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Consultation response on legislative proposals for clinical trials published by MHRA

MHRA has published the consultation response on their proposals for legislative changes for clinical trials. "We will introduce new legislation and guidance as part of a swathe of new measures that represent the biggest overhaul in UK clinical trials regulation in over 20 years. These bold new measures will make the UK one of the best countries in the world…
admin
March 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA request to engage earlier for safety issues

MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety. Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD…
admin
March 17, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 6 Mar)

Please note this is an extract of the original bulletin. Advisory Group Reform Proposals Page summary: Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. Change made: First published. MHRA fees Page summary: Fees payable to the MHRA for 2022 to 2023 Change made: Added link to application form to ‘apply for Small and Medium Company…
admin
March 17, 2023
Membership NewsMembership News Archive

The Budget: BIVDA Briefing and Reaction

The Chancellor, Jeremy Hunt, set out his inaugural Budget on Wednesday with three key aims in mind: improving growth, getting people back to work and controlling the UK’s debt. While it remains to be seen whether these grand goals will be achieved, there was plenty else of interest for IVD companies wondering what the Government will do to help them…
Natalie Creaney
March 17, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Feb)

Please note this is an extract of the original bulletin. MHRA Graduate Scheme Page summary: Information about the MHRA’s Graduate Scheme and how to apply. Change made: First published.   Working for MHRA Page summary: Information on how to apply for jobs, workplace benefits and skills development at the Agency. Change made: Added link to MHRA graduate Scheme.   Medical…
admin
March 9, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (20 Feb)

Please note this is an extract of the original bulletin. Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Page summary: The EU Commission has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates Change made: First…
admin
March 9, 2023
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA held joint workshop with MHRA on IVD Roadmap

Dear members, BIVDA held a joint in-person workshop with the MHRA on the future IVD Roadmap. This took place on 10 February at the MHRA offices. The aims of this were to understand: The IVD ecosystem The gaps in the landscape MHRA’s role in this The needs for pre-market support The barriers and enablers for market access The workshop was…
Ben Kemp
February 24, 2023
ConsultationsConsultations Archive

Consultation response – Proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees

The MHRA led on a joint consultation on proposed amendments to the MHRA’s statutory fees with the Department of Health in Northern Ireland, in accordance with Section 45(1) of the Medicines and Medical Devices Act 2021. The consultation ran between 31 August and 23 November 2022 to seek views on proposals to update the statutory fees charged for the MHRA’s…
Natalie Creaney
February 3, 2023
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