Hi
This is a case with all the applied standards of your product. Every time a standard is revised, you have to perform a gap analysis and comply with the new standard. If your gap analysis indicates that you do not have to perform new studies, you have to justify your selection.
In any case, your CE mark is still valid, but the Notified Body will check your compliance.
Hope that helps
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Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
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Original Message:
Sent: 21-Mar-2019 12:31
From: Anonymous Member
Subject: CE Mark
This message was posted by a user wishing to remain anonymous
Hi Everyone,
If your EC certificate hasn't expired and you have not tested medical devices for the latest IEC 60601-1 3.1 edition and EMC 4th edition, can you still affix CE mark to your products?
Thanks