CEPK

Medical device registration 🇬🇧 The updated guidance for registration of medical devices in Great Britain and Northern Ireland now includes clarification on requirements in case of changed device characteristics, references to IVDR transitional guidance, and clarifications to requirements for Northern Ireland based authorised representatives. https://lnkd.in/dDfseeT #Medicaldevices #Diagnostics #UnitedKingdom #Regulatory #Requirements

🌷Adverse event reporting🌷 The updated IMDRF guidance on terminology and codes for adverse event reporting is now available. Annex A to G have been updated and are now included in a single file (rather than multiple separate files). The annexes include terms and codes to identify medical device problems, investigate causes and determine the health effects of the problems. https://lnkd.in/dsK-kVDN #Medicaldevices #Diagnostics #Regulatory #Requirements #Compliance

Machine learning-enabled medical devices ⭐ The 🆕 guidance for machine learning-enabled medical devices (MLMD) provides an overview of information to include in applications submitted to Health Canada. This includes information required on good machine learning practice (GMLP), design, data selection, data management, development, training, testing, evaluation, clinical validation, transparency and post-market monitoring. https://lnkd.in/duBcs8JB #Medicaldevices #Artificialintelligence #Software #Regulatory #Requirements

CE marked medical devices in the UK 🌸 The new guidance from the Medicines & Healthcare Products Agency (MHRA) outlines registration requirements for medical devices that are CE marked under the transitional provisions from EU MDD to MDR. The guidance contains 6 specific scenarios, outlining the necessary steps for registration with the MHRA. #Medicaldevices #UnitedKingdom #Regulatory #Requirements #Compliance

Multinational clinical studies 🌐 For sponsors of MDR or IVDR clinical studies planned in more than one member state, the new pilot project for coordinated assessment is now accepting applications - the deadline is 30 June 2025. The purpose of the coordinated assessment is to allow sponsors to submit a single application to reduce the administrative workload and ensure a consistent assessment process across member states who participate in the project. The full eligibity criteria for applicants are included in the announcement from the European Commission: https://lnkd.in/da4WURZd #Medicaldevices #Diagnostics #EuropeanUnion #ClinicalTrials #Compliance

Congratulations to NCPS, Spain - the latest IVDR notified body 🌼 https://lnkd.in/e5iwED33 #Medicaldevices #Diagnostics #EuropeanUnion #Regulatory #Compliance

ℹ️Software & artificial intelligence (AI) as a medical device🌸 The updated guidance includes information on medical device qualification and classification for software, post-market surveillance and vigilance requirements, and information specific to artificial intelligence enabled devices, e.g. principles on good machine learning practice (GMLP). https://lnkd.in/g_qkHtkT #Software #Artificialintelligence #Medicaldevices #UniteKingdom #Requirements

🌸MDR and IVDR vigilance🌸 The MDCG guidance on vigilance terms and concepts has been updated to align with Eudamed requirements and to include reference to the post-market surveillance and vigilance module. https://lnkd.in/dP3su5Qv #Medicaldevices #Diagnostics #EuropeanUnion #Data #Analysis

𝓔𝓾𝓭𝓪𝓶𝓮𝓭 - 𝓰𝓻𝓪𝓭𝓾𝓪𝓵 𝓻𝓸𝓵𝓵-𝓸𝓾𝓽 🦋 The new guidance contains questions and answers regarding the gradual roll-out of the Eudamed database. This includes information on the mandatory use of each module 6 months after the publication in the Official Journal of the European Union confirms the functionality of the module in question. https://lnkd.in/dfuJC5mx #Medicaldevices #Diagnostics #EuropeanUnion #Regulatory #Requirements

✨UK Medical Devices Regulations✨ The Medicines and Healthcare products Regulatory Agency (MHRA) has published an open consultation for the upcoming UK regulations for medical devices and in vitro diagnostic devices. The consultation covers topics such as international reliance (access to the UK market if already approved in other territories), UKCA marking, and assimilated EU law. The deadline for feedback is 5 January 2025. https://lnkd.in/da-mUgRa #Medicaldevices #Diagnostics #UnitedKingdom #Regulatory #Requirements