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Nov 11, 2011 · How to obtain European CE marking for your medical device. CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. We have a detailed chart explaining the current European CE approval process for medical devices here. However, the ...

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In which countries is the CE marking required?

Apr 22, 2015 · The CE marking is currently required in the following countries: 1. Austria (since 1995) 2. Belgium 3. Bulgaria (since 2007) 4. Czech Republic (since 2004) 5. Cyprus (since 2004) 6. Denmark 7. Estonia (since 2004) 8. Finland (since 1995) 9. France 10. Germany 11. Greece 12. Hungary (since 2004) 13. Iceland 14. Ireland 15. Italy 16. Latvia ...

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The good news - The most obvious benefit is that the CE Marking on your product will gain you access to the European Economic Area (EEA). If the European product directives apply to your products and you want to continue to export to the European market (or introduce new products), then CE Marking is mandatory and therefore crucial to your success.

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Jun 16, 2020 · The Medical Devices Directive applies to products meant to protect the patient rather than the wearer. This includes medical masks and a range of other medical devices. Further, Medical Devices is classified as class I, II, and III. Class II and III require the involvement of a Notified Body. Laboratory testing requirements

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