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Concept of MDR Medical Device Regulation.

MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

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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

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MHRA Publish Revised Roadmap for Implementation of Medical Devices Future Regime

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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

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MHRA trials five innovative AI technologies as part of pilot scheme to change regulatory approach

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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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Christmas & New Year Shutdown Period

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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

Technology Tracking System

New Malta Medicines Authority’s Email address for Vigilance

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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

Concept of MDR Medical Device Regulation.

MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED

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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

Concept of MDR Medical Device Regulation.

MDCG 2024-14 Guidance on the implementation of the Master UDI-DI solution for contact lenses

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The MDCG has recently published a guidance document regarding the implementation of the Master UDI-DI solution for contact lenses. To offer some background to this document, the Unique Device Identification (UDI) system, outlined in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR), is designed to ensure robust identification and traceability of medical devices. … Read more

EU Commission Release Q&A regarding Gradual Rollout of EUDAMED

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The European Commission has recently released a comprehensive Q&A document designed to assist manufacturers and other stakeholders in understanding the new amendment concerning the phased implementation of EUDAMED. This amendment, introduced through Regulation (EU) 2024/1860, was published in mid-June and addresses three key areas within the framework of the Medical Device Regulation (MDR) and In … Read more

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Advena at MEDICA 2024

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As many of our clients are aware, in November we had the privilege of exhibiting our services at MEDICA in Dusseldorf. Over the four days of the exhibition, the halls of MEDICA were filled with dynamic conversations and meaningful exchanges. We had the privilege of meeting with manufacturers from across the globe, each driven by … Read more

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Advena Ltd

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BKR 4013. Malta
Reg. in Malta No. C 76865

Advena Services Ltd

Registered Address:
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BKR 4013. Malta
Reg. in Malta No. C 103067

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Reg. in the UK No. 13789474

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20122 Milan
Italy
Company No: MI-2785259

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