A new UK Approved Body has been designated. The mew UK Approved body is Eurofins E&E CML Limited and isbased in Ellesmere Port UK. The current list of UK Approved Bodies can be seen in the table below, that being said, please be aware that the list is always being updated. UK Approved Body Number … Read more
The medical device scope of the UK Approved Body BSI Assurance UK Ltd and DEKRA Certification UK Ltd havebeen updated. In addition, DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope. The current list of UK Approved Bodies can be seen in the table below, that being said, please be aware that the list is … Read more
The MHRA has released a guidance document regarding the Post-Market Surveillance. To offer some background to this newly released guidance document, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 updates the UK Medical Devices Regulations (MDR) 2002 by introducing a new section (Part 4A) that outlines post-market surveillance (PMS) obligations for medical … Read more
The MHRA has recently updated the roadmap which outlines for Implementation of Medical Devices Future Regime. This provides a further update on the intended timelines to implement the future medical device regulations. The updated revision provides updates in 4 key areas: Progress of Post-Market Surveillance (PMS) Statutory Instrument (SI) in Legislation The Post-Market Surveillance (PMS) … Read more
The Medicines and Healthcare products Regulatory Agency (MHRA) has selected five innovative technologies for its AI Airlock pilot scheme. This initiative aims to explore how AI-powered medical devices can be regulated in a way that ensures they reach the NHS and patients quickly and safely. The chosen devices have the potential to greatly enhance the … Read more
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government body tasked with ensuring the safety and effectiveness of medical devices for patient use. Medical devices encompass a wide range of products and equipment designed for medical purposes, including diagnosing, preventing, monitoring, or treating diseases or injuries. Examples include pacemakers, artificial hips, blood … Read more
In addition to the consultation on the future regulation of medical devices in the UK, the government plans to introduce legislation in 2024 that will strengthen Post-Market Surveillance (PMS) requirements in Great Britain ahead of broader regulatory reforms. This initiative reflects the government’s commitment to enhancing patient safety as part of the upcoming medical device … Read more
The MHRA has released a draft policy concerning recognition of international regulators’ approvals of medical devices. The policy describes how the MHRA will be able to use the expertise and decision making of other regulatory partners for the ultimate benefit of patients. That being said, the MHRA will retain the authority to reject applications at … Read more
In early March, the MHRA presented a webinar to discuss the upcoming changes to the Medical Device regulations for the UK. From the webinar, it is quite clear that the MHRA is doing their best to align the new regulations with the MDR and IVDR. Various topics were discussed in this webinar and will be … Read more
LNE-GMED (8521) and Scarlet (8536) have just been given approved body status by the Medicines and Healthcare Products Regulatory Agency (MHRA). These new additions bring the total number of UK approved bodies to 9. The full scope of LNE-GMED can be accessed using the following link The full scope of Scarlet can be accessed using … Read more
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