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Coronavirus Test Device Approvals Transition

The UK Coronavirus Test Device Approvals function is currently managed by UKHSA. The MHRA will take over this function from 24 May 2023. A guidance confirming the changes to process management will be published by the MHRA on 24 May. The MHRA have provided the following information: The UK Coronavirus Test Device Approvals regulatory regime is one of the most…
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May 12, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 May)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration…
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May 12, 2023
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MHRA survey on PMS costs – deadline 17 May

To better understand the implications of proposed Post Market Surveillance (PMS) to manufacturers of medical devices, the MHRA would like to be provided with data on firms' expected cost of compliance with PMS regulations so far. This survey covers total costs of setting up a PMS system across an organisation, and the cost of maintaining a PMS. This firm level…
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May 5, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 17 Apr)

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…
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April 28, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA extends MORE portal deadline to 31 August

MHRA have extended the deadline for their new MORE portal to 31 August. It was initially intended to be mandatory for vigilance reporting to MHRA from April. MHRA have provided the following information: The MHRA has been listening to feedback and engaging with device manufacturers and stakeholders since the new MORE portal was launched in November 2022. We understand that…
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April 21, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 3 Apr)

Please note this is an extract of the original bulletin. MHRA fees Page summary: Fees payable to the MHRA for 2023 to 2024 Change made: Updated MHRA fees for 2023 – 2024 New statutory fees for MHRA services introduced from 1 April 2023 Page summary: Changes have been designed to ensure the agency is resourced to provide patients, the public…
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April 14, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Mar)

Please note this is an extract of the original bulletin.   Export medical devices Page summary: Order a certificate of free sale to export medical devices outside the UK. Change made: Updated ‘Certificates of Free Sale for Medical Devices’ PDF.   Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines…
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April 6, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 Mar)

Please note this is an extract of the original bulletin.   Consultation on proposals for legislative changes for clinical trials Page summary: We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines Change made: Government response…
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March 31, 2023
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MHRA has confirmed EU amendment to MDR will apply in Northern Ireland

MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…
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March 31, 2023
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