Question
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
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...
The most common nonconformity identified by reviewers of a CE Marking submission is an inadequate or missing clinical evaluation report (CER). Preparing a CER is time consuming, but if you have a good protocol and procedure the process does not need ...
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...
Since the EN version of ISO 14971 was released in 2012 I have received lots of requests from clients to help address nonconformities from Notified Body auditors. In the past year the frequency of this nonconformity has increased substantially.The FDA...
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...
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,...
If you have a moderate risk device you probably will submit a 510(k) before applying for CE Marking, because some of the requirements for a technical file are more challenging than European requirements.Risk Management FileThe FDA only requires docum...
