The latest amendment to ISO 15223-1:2021 (Amd 1:2025) has been published, introducing crucial updates to enhance global compliance, clarity, and consistency in medical device labelling. As regulatory requirements evolve, these changes are essential for manufacturers, authorised representatives, and other stakeholders to ensure seamless international acceptance of their products. The key updates include: The updated standard … Read more
The EU Commission has published the draft regulation regarding the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles. The aim of this regulation is to resolve the implementation issue concerning the registration of UDI-DI data elements in EUDAMED for the mentioned devices, similar to what was done for contact … Read more
The guidance document MDCG 2019-6 Rev5 Questions and answers: Requirements relating to notified bodies has been updated. To offer some background to this document, initially released in 2019, this guidance document was released to provide a compilation of questions and answers regarding the requirements for notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) … Read more
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
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
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
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
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 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
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