If the medical device is legally CE Marked according to the MDD, the answer is no. A medical device that has a Declaration of Conformity states the device is compliant with all regulatory requirements of the MDD and any associated standards. If the medical device has a valid CE Certificate from a Notified Body, this is also approved in the European Union.
However, if you have an approved medical device that is being used for an indication outside of the Declaration of Conformity (as stated in the labelling and technical documentation) or outside of the CE Certificate than it may be considered an investigational device. Though "off-label" use is not quite monitored in Europe (at the moment) and/or the indications for use if general enough may not push the indications outside of the Declaration or approved CE Mark.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 02-Nov-2018 16:53
From: Anonymous Member
Subject: CE marked device for investigational use
This message was posted by a user wishing to remain anonymous
Hello,
A CE marked medical device is also being used for a clinical trial in Germany. Noting that it is CE marked - do we still need to label it "for investigational use only" when we send the device to the investigational site?
Thanks in advance!