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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...
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,...
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...
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...
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...
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...
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
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...
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...
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...
