As many of our readers are aware, during the end of January and beginning of February, Advena had the opportunity to visit a number of fairs being held in Dubai: Arab Health, Medlab Middle East, and AEEDC. These prestigious exhibitions provided an excellent opportunity for us to connect with industry leaders, explore the latest innovations, … Read more
The Latest version of the IVDR has been published in HTML format. The .pdf version is expected to be released in the near future. To access the latest consolidated version of the IVDR, click on the following link
The MDCG guidance document MDCG 2023-3 has been updated. Originally published in 2023, this document aims to clarify key terms and concepts outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Establishing a shared understanding of these terms … Read more
Attending Arab Health 2025 in Dubai was an exceptional experience, offering a unique platform to connect with a diverse array of manufacturers from around the world. The event facilitated meaningful interactions, allowing us to assist numerous companies in navigating the intricate landscape of EU regulations. For those who were unable to meet with us at … 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 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
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