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
The EU Commission has released a Q&A document regarding the Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices or In-Vitro Diagnostic Devices, a measure first introduced in the amendment (EU) 2024/1860. To offer some background to this document, earlier this year, an amendment to the IVDR and MDR, dubbed … Read more
The regulatory status of ethylene oxide (EtO) for sterilizing single-use medical devices during manufacturing has been examined within the scope of the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). EtO is widely used to sterilize various medical products, including medical devices, in vitro diagnostic medical devices (IVDs), medicinal products, and combination products. … Read more
There has been an update to the guidance document MDCG 2022-5 concerning guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices. The update includes the addition of products specifically intended for the cleaning, disinfection or sterilisation of medical devices in section 1.2.6.1 to the list of examples of … Read more
The EU Parliament has adopted a resolution to revise the MDR and IVDR to address the ongoing challenges regarding implementation and support patient access to essential medical devices by 2025. The EU Parliament’s proposed amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are timely, balancing much-needed reform with a commitment … Read more
To provide some context, a harmonized standard is a European standard developed by recognized European Standards Organizations such as: These standards are created based on a formal request from the European Commission. They are crucial for manufacturers, economic operators, and conformity assessment bodies, as they offer a recognized way to demonstrate compliance with relevant EU … Read more
The MDCG has recently published a guidance concerning the qualification of in vitro diagnostic medical devices. The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) or an accessory to an IVD. For a product to qualify as an IVD or … 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
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