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HighlightsHighlights Archive

MHRA increases UK assessment capacity for IVDs

MHRA has confirmed that UL International UK Ltd is now designated to assess most IVDs, increasing the UK’s capacity to process conformity assessments. UL International UK Limited have had their current designation as an approved body extended to include almost all Part IV In-vitro Diagnostics Medical Devices, adding to the capacity already provided for these types of products by BSI…
Ben Kemp
January 27, 2023
ConsultationsConsultations Archive

Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety

The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. They seek to improve the way they communicate with healthcare professionals. They want to hear from you to enable them to transform how they communicate with you and how they work together on your common goal of greater patient safety.…
Natalie Creaney
January 13, 2023
HighlightsHighlights Archive

MHRA to receive nearly £1m BEIS funding to unlock digital, data and scientific regulatory innovation

MHRA will receive the near £1 million support to fund three projects that aim to improve how patients can access life-changing treatments in clinical trials, find a way to introduce complex AI safely into front line clinical settings and make the UK the place to launch advanced microbiome products that can support the development of personalised medicine. The first project…
Natalie Creaney
January 13, 2023
HighlightsHighlights Archive

The MHRA add first post-Brexit UK Approved Body to certify medical devices

The MHRA have increased their capacity to process conformity assessments for medical devices with the addition of DEKRA Certification Ltd to their existing three UK approved bodies. This will ensure that safe and effective devices can reach the public faster. DEKRA has become the first organisation to complete the new designation process that any potential organisation must now go through…
Natalie Creaney
September 30, 2022
Membership NewsMembership News Archive

Help shape the development of the new regulatory management system at the MHRA!

In the summer, the MHRA launched a project to replace their existing regulatory management IT systems with new digital products. They state that this will help them to better protect public health by delivering an optimised IT infrastructure that improves their services and modernises their IT estate. Their new regulatory management system will provide modern technology to manage their processes…
Natalie Creaney
September 23, 2022
Regulatory Affairs Working PartyRegulatory Affairs Working Party Archive

MHRA to change method of reporting adverse events

On 18 August, MHRA held a webinar to explain what changes are coming in how adverse events vigilance reports should be submitted. The current MORE reporting system is being updated to a new MORE system. This means that adverse event reports must be submitted using this new system from November 2022 or via MHRA’s custom API for direct submission through…
Natalie Creaney
August 19, 2022
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