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#EUMDR #MedicalDevices #RegulatoryAffairs #RoyedTraining
BVMedDie EU-Kommission plant die praxisuntaugliche EU-Medizinprodukteverordnung (#EUMDR) zu evaluieren und zu verbessern. 🛠️ Dass das wichtig und richtig ist, zeigen aktuelle Herausforderungen und Warnsignale durch die MDR. Sie machen aber auch deutlich: Wir benötigen zusätzlich dringend kurzfristige untergesetzliche Maßnahmen. 📢
📰 Mehr: bvmed.de/pm2025
Peter Liese MEPRT @MCBeeres: Die strukturellen Probleme der #EUMDR bleiben ungelöst. Die Verordnung muss strategisch weiterentwickelt werden. Der @BR24-Film gibt Einblicke in die Praxis der #Orthopädie und #Kinderkardiologe. @peterliese nimmt ebenfalls klar Stellung. @BVMed @BVMed_MDR
🐦🔗: https://n.respublicae.eu/peterliese/status/1638822584195358720
RT @BVMed: Unsere #MedTech-Themen im neuen BVMed-Newsletter:
➡ #Mangelernährung und #Ernährungstherapien bei Krebs
➡ @StephPilsinger beim BVMed zur #Krankenhausreform
➡ #IPCEI-Anhörung im Wirtschaftsausschuss mit @DorotheeStamm
➡ @peterliese zur #EUMDR
https://www.bvmed.de/de/bvmed/publikationen/bvmed-newsletter/medtechnews-230306
🐦🔗: https://n.respublicae.eu/peterliese/status/1632681633382903809
RegulatoryDadSo tying it all together, why would Canadians or other countries be concerned about #EUMDR? Well, the TL;DR is that smaller markets like Canada often share #MedicalDevice economies of scale by holding close or identical product offerings across #Regulatory jurisdictions. In Canada, our #MedTech regulator, #HealthCanada has #SignificantChange requirements which could be downstream of major markets like the European one. As a result, some companies must make difficult decisions in response to #MDR with unexpected downstream impacts, especially when it triggers retesting and refiling of submissions for legacy technologies. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html
Continuing on the #MedicalDevice #Regulatory theme of #EUMDR, European Council Members are in support of a proposal to extend the tightening of EU #MedTech regulations for 3 more years. Stay tuned in the new year for details and specifically the legal text from #EPSCO. https://data.consilium.europa.eu/doc/document/ST-15520-2022-INIT/en/pdf
RT @CPME_EUROPA: 📢 European doctors are concerned about availability of medical devices and ask European Commission to take necessary action
👉 Our letter to @EU_Commission: https://www.cpme.eu/news/european-doctors-ask-european-commission-to-ensure-availability-of-medical-devices-in-europe