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    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2020
    A Harder-To-Get CE Mark
    FDA detractors have long complained it's faster and easier to earn a Conformité Européen (CE) mark versus FDA clearance. Is that about to change? Maybe, in light of revised text for new regulations proposed by the European Commission. You can partial...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    April 2020
    Is a CE mark "good enough"?
    As you know, medical devices sold in America require FDA clearance.Is gaining FDA clearance more stringent than obtaining a CE mark? And a question for regulatory experts in our group: Is it defensible for your sales reps to say to a prospect, "Well,...
    Ong Kean Seng
    Senior Manager Regulatory Affairs at InQpharm
    September 2018
    Is QMS certification an EU must to obtain CE marking
    I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certi...
    Antonia Trevisan
    regulatory engineer presso Lima Corporate
    August 2018
    MDR: Are custom-made devices exempt from CE marking?
    I have a question on MDR implementation: Is it confirmed that custom-made devices are exempt from CE marking?According to MDR art.20 par.1, and art.52 par.8, I believe that custom-made devices are exempt from CE marking. Are there any conflicting int...
    Ilan Goldberg
    Sr. QA/RA Expert at Physio-logic Ltd.
    November 2017
    Indicating CE Marking on product' catalogue
    Our product received CE certification. In addition to the product labels and IFU, We would like to indicate in our product' catalogue the CE Marking with N.B number. Is it allowed? Please explain/Make citation.Thank you.source: https://www.linkedin.c...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    November 2016
    Can we consider Israel representative as a part of EU representative for CE marking ?
    As originally asked by Divya G. EU representative for CE marking: is Israel consider an European address in your point of view? Julie Omohundro Principal Consultant at Class Three, LLC Divya, just put your cursor over Stacy's name next to her comment...
    Fiona Dunlevy
    Medical writer and science communicator at Axcience
    September 2016
    Where to find a list of CE marked devices?
    Hello, I'm wondering if there's a centralized publicly available list/ database of medical devices that have received the CE mark in Europe?Thanks for helping!Fiona
    Arthur Brandwood
    Medical devices and IVD regulatory expert with a global perspective
    August 2016
    Brexit and the CE mark. Where now for the UK's MHRA and the British Notified Bodies?
    The UK's MHRA has been a leading influence in the European regulation of devices. What does Brexit mean for UK Medtech - and the broader regulation of devices in Europe?Brexit and the CE Mark - implications for European regulation of medical devicesT...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    July 2016
    Easier to obtain CE Mark approval than FDA clearance?
    How do you see this changing going forward?Study: Initially CE Marked medical devices have higher recall rateU.S. medical devices which won CE Mark approval in the European Union prior to gaining FDA clearance have a nearly 3 times higher rate of saf...
    Julie Omohundro
    Principal Consultant at Class Three, LLC
    June 2016
    Impact of Brexit on CE Marking?
    Anyone here have any initial thoughts about the potential impact of Brexit on CE Marking?What is likely to happen with CE certifications issued by BSI or other MHRA-designated notified bodies?Is Brexit likely to have an impact on the process for fina...
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