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The Medical Device Coordination Group (MDCG) published Revision 4 of its guidance document MDCG 2020-16, titled "Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746". This updated version provides further clarification on the application of the classification rules outlined in Annex VIII of the IVDR.
The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices in Great Britain. The document, titled "The Medical Devices Post-Market Surveillance Requirements (Amendment) Great Britain Regulations 2024: Guidance on Implementation," provides clarification and details on fulfilling the regulatory obligations for manufacturers.
The International Organization for Standardization (ISO) has recently amended ISO 15223-1:2021, introducing a change from "EC-REP" to "EU-REP" for the European Authorized Representative symbol.
Swissmedic, the Swiss Agency for Therapeutic Products, has released findings from a recent focused action, underscoring the critical importance of robust Post-Market Surveillance (PMS) for all medical devices, including those classified as Legacy Devices (LDs). The review emphasizes that manufacturers must actively monitor the performance and safety of their devices throughout their lifecycle.
The In Vitro Diagnostic (IVD) expert panel of the European Commission has released new scientific advice regarding SARS-CoV-2. The panel notes that, while the virus can still cause serious illness, it no longer poses a life-threatening risk with a significant mortality rate for the general European population.
The European Commission has launched a public consultation as part of its targeted evaluation of the EU rules on medical devices and in-vitro diagnostics. This initiative is focused on assessing the effectiveness, efficiency, relevance, and coherence of the current regulations. It aims to ensure that the regulatory framework continues to support innovation, public health, and safety in the rapidly evolving medical technology sector.
The European Commission has released the second revision of the MDCG 2023-3 guidance document in January 2025. This update includes important clarifications in line with Regulation (EU) 2024/1860, affecting the implementation of Eudamed, post-market surveillance, and reporting timelines. Below, we summarize the key changes:
The European Commission has issued the revised MDCG 2022-4 guidance, focusing on appropriate surveillance during the transition from the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to the Medical Device Regulation (MDR).
We're pleased to provide you with important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607. As the landscape of medical device regulations continues to evolve, it's crucial for stakeholders to remain informed and compliant.