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 European Commission has initiated a public consultation and call for evidence as part of a targeted evaluation of the EU legislation on medical devices and in vitro diagnostic medical devices. This consultation offers stakeholders the chance to share their views on the effectiveness of the current regulations and identify any potential shortcomings. The regulations … Read more
Pursuant to the Q&A document published by the EU Commission, the manufacturer (or any relevant actor on behalf of the manufacturer) will need to inform the competent authority of a interruption or discontinuation of supply of certain medical devices and certain in vitro diagnostic medical devices using a form referred to as the ‘Manufacturer Information … 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
A New consolidated version of the MDR has been published in .html format with the inclusion of Article 10a. The .pdf version is expected to be released in January 2025. The .html version can be accessed using the following link
As a reminder, we would like to highlight to all clients the dates for our annual Christmas and New Year office shutdown period. We will close for the festive period on Friday 20th December 2024 at 14:30 hrs central European time. Reopening on Monday 6th January 2025 at 09:00 hrs central European time. Therefore, time … Read more
We would like to inform our clients that the Maltese Competent Authority, the Malta Medicines Authority (MMA), has introduced a new dedicated email address for vigilance communications. The updated email address is: mdvigilance.medicinesauthority@gov.mt Please be aware that the official Vigilance contact points list published by the European Commission (available at this link) has not yet … Read more
A guidance document has been released on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. To offer some background to this guidance document, Article 77(5) of the MDR mandates that sponsors submit a clinical investigation report to the Member States where the clinical investigation was conducted within one … Read more
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