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The regulatory landscape for medical devices and in vitro diagnostic medical devices is continuously evolving, with the introduction of new technologies like Artificial Intelligence (AI) adding layers of complexity.
The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).
In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.
The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms." This document, published in June 2025, clarifies the regulatory obligations for all parties involved in bringing MDSW apps to the EU market, with a particular emphasis on online platform providers. This article provides a concise overview of its key takeaways for regulatory professionals.
The European Commission has released a new version of the Manufacturer Incident Report (MIR) form-MIR 7.3.1-which will become mandatory for all medical device and IVD manufacturers from November 2025. This update is a significant step in harmonizing and streamlining incident reporting processes across the European Union, in line with the MDR and IVDR requirements.
The European Commission is hosting a free, hybrid EUDAMED workshop in Stuttgart on May 21, 2025, designed to support the onboarding of all actors involved with the European Database on Medical Devices (EUDAMED).
The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the Medical Device Regulation (MDR, EU 2017/745). The latest update, formalised through Commission Implementing Decision (EU) 2025/681, introduces new harmonised standards covering medical gloves for single use, sterilisation of medical devices, and patient handling equipment in ambulances.
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.