Genelife Clinical Research4d ago

We wrote about medical device clinical trial design in 2011.

The problem we identified then: no perfect control, operator dependency, trial outcomes that don't match real-world practice.

Fifteen years later — same problems. Dramatically better toolkit.

Is your clinical program designed for the regulatory environment that exists today?
https://genelifecr.blogspot.com/2026/06/clinical-research-in-medical-devices.html

#MedicalDevices #ClinicalTrials #EUMDR #FDA #ClinicalResearch #RealWorldEvidence #CRO

Clinical Research in Medical Devices: Revisiting Innovative Design — Fifteen Years On

Explore advances in medical device clinical trials, including adaptive designs, RWE, EU MDR, and digital innovation.

Genelife Clinical ResearchJun 15

The era of minimal pre-market device evaluation is over. The question for every device company now is whether their clinical program is designed for the regulatory environment that actually exists — or for the one that existed a decade ago.

#MedicalDevices #ClinicalResearch #MedicalDeviceTrials #EUMDR #FDA #CDSCO #ClinicalTrialDesign #RealWorldEvidence
https://genelifecr.blogspot.com/2026/06/clinical-research-in-medical-devices.html

Clinical Research in Medical Devices: Revisiting Innovative Design — Fifteen Years On

Explore advances in medical device clinical trials, including adaptive designs, RWE, EU MDR, and digital innovation.

BVMedMar 19, 2025

Die 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 MEPMar 23, 2023

RT @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

Peter Liese MEP (@peterliese)

RT @MCBeeres: Die strukturellen Probleme der #EUMDR bleiben ungelöst. Die Verordnung muss strategisch weiterentwickelt werden. Der @BR24-Fi…

Nitter
Peter Liese MEPMar 6, 2023

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

MedTech-News

In dieser Woche wird zum Tag der gesunden Ernährung wieder viel über Nahrungsmittel gesprochen. Was wenige wissen: Wir haben in Deutschland...

RegulatoryDadDec 19, 2022
So 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
Guidance for the Interpretation of Significant Change of a Medical Device - Canada.ca

2003 (revised 2011) Health Canada guidance document

RegulatoryDadDec 19, 2022
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
Peter Liese MEPNov 24, 2022

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

#MDR #EUMDR #Medicaldevices #EPlenary

🐦🔗: https://nitter.eu/peterliese/status/1595737486613180417

European doctors ask European Commission to ensure availability of medical devices in Europe

CPME.eu