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
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
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
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
We are thrilled to share some exciting news! We will be attending three of the most prestigious healthcare events in Dubai, and we would love to meet you there! These globally recognized fairs are a hub for innovation, networking, and discovering the latest advancements in healthcare and medical technologies. Here’s where you can find us: Whether … Read more
There has been an update to the guidance document MDCG 2023-3. Originally published last year, this document provides clarification on key terms and concepts outlined in Section 2, Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Its purpose is to establish a … 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
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