European Medicines Agency’s Post

Regulatory News from 💧*Mexico: Cofepris improves transparency by publishing a guide for obtaining health registrations for medical devices.* Subscribe now to read the full story 👇: https://lnkd.in/dUiFxgap #cofepris #medizinprodukte #medicaldevices #dispositivosmedicos #dispositivimedici #dispositifsmedicaux #regulatoryaffairs

Are you a medical device manufacturer looking to expand into Mexico ? Dive into our blog post where we uncover the intricacies of Mexico's medical device registration pathways. Whether you're interested in standard or expedited review routes, we've got you covered! Discover Key Insights: · Understanding Mexico's regulatory landscape · Navigating standard registration processes · Exploring expedited review routes for faster market access · Key considerations for successful registration Don't miss out on this valuable resource! Read the full article here: https://lnkd.in/dbBY6Z5d #COFEPRIS #MedicalDevices #RegulatoryCompliance #MarketAccess #MexicoRegulations #HealthcareIndustry #MedicalDeviceRegistration #Blog #ArtixioInsights

Are Medical Device Suppliers Equipped for the Escalating Regulatory Landscape? The global medical devices market is projected to surpass $886 billion by 2032. As these devices become increasingly critical to patient outcomes, regulators are tightening their quality and safety expectations. But how well prepared are suppliers to meet these rising standards? We recently commissioned independent research to find out. The 2024 study surveyed 202 regulatory professionals at Class 2 and 3 medical device companies in Germany and the US. The findings highlight several key challenges and assess the current state of regulatory readiness among device suppliers. Read the article here: https://lnkd.in/ezWnaknB

#UK #MHRA News!! (Medical Devices Future Roadmap) Today (9/1) the MHRA has published the "MHRA Roadmap towards the future regulatory framework for medical devices". #medicaldevices #roadmap

I'm pleased to say that the study on the implementation of Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) has been published. S&P Global were part of a multinational team, led by Gesundheit Österreich GmbH, which carried out this study for the European Commission. The study evaluated how the provisions established in Article 17 MDR have been implemented and how such provisions function in practice across the EU-27, Iceland, Liechtenstein and Norway. This report highlights where the reprocessing of single use medical devices is permitted and where it is not and reports on the reuse of purchased reprocessed SUDs by health institutions. The report provides a series of conclusions and recommendations for optimising the implementation of Article 17 MDR in Europe. https://lnkd.in/eZNDK44g

Regulatory News from 💫Spain: AEMPS has launched a new consultation on the qualification and classification of medical devices and IVD💫 Subscribe now to read the full story: 👉 https://lnkd.in/dUiFxgap #regulatoryaffairs #medicaldevices #dispositivosmedicos #dispositifsmedicaux #aemps #medizinprodukte #medtech #dispositivimedici

Almost 10,000 products could still be waiting for certification under the new EU Medical Devices Regulation (MDR) according to The European Association of Medical devices Notified Bodies (TEAM-NB) Medical Device Survey 2023, published this May, which could cause shortages of life-saving devices. Find out why: https://hubs.li/Q02Hhrqy0 Farah Ahmed, Marta Villarraga, Michael Frohbergh, Grigoris Grigoriadis #Exponent #Alert #LifeSciences #RegulatoryAffairs #Biomedical #MedicalDevices #MedicalDeviceManufacturing #MedicalDeviceIndustry

Regulatory Pathway for Medical Devices Under the Medical Device Rules, 2017: From Development to Commercialization for Manufacturers and Importers The regulatory pathway for medical devices under the Medical Device Rules, 2017, entails a detailed process that manufacturers and importers must follow from the initial development stage to commercialization. This pathway ensures compliance with stringent standards for safety, efficacy, and quality.

IMDRF Submission Format for Medical Device The International Medical Device Regulators Forum (IMDRF) does not prescribe a specific submission format for medical devices but provides frameworks and guidance to harmonize regulatory practices across its member countries. Read more: https://lnkd.in/gW-y4k5M #eCTD #Regulations #IMDRF #ISOStandards #MedicalDeviceRegulation #RegulatoryCompliance #SubmissionGuidelines #MedicalDevices