Hello,
My recommendation is following how the device actually conforms to the requirements/regulations. Because your Class I non-sterile, non-measuring device is self declare, you need a quality management system, technical documentation, and declaration of conformity. The declaration of conformity is exactly that, declaring the device conforms with MDD 93/42/EC. Be careful about saying statements like approved or accepted, because there is no independent review - maybe use words like 'CE Marked in conformity with MDD 93/42/EEC' or 'compliant with requirements of MDD 93/42/EEC for CE Marking'. Just note as of 26 May 2021, those Class I devices need to be compliant to the EU MDR 2017/745 as the date of application will then apply; so making statements about compliance to MDD 93/42/EEC after May this year might not be good either.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 04-Feb-2021 02:23
From: Britta Cyron
Subject: Class I CE mark - Market Announcement
Hi,
since with a class I device you yourself declare conformity with the relevant directives and regulations (CE-marking) your statement might better point in a slightly different direction. Maybe something like "our device is now cleared for the european market"
Hope this helps
Britta
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Britta Cyron
Bochum
Germany
Original Message:
Sent: 03-Feb-2021 12:37
From: Anonymous Member
Subject: Class I CE mark - Market Announcement
This message was posted by a user wishing to remain anonymous
Hi RAC community,
We have a Class I device non-measuring, non-sterile, and non-reusable as per 93/42/eec. The product is self-declared and we are in the process of registering the device with a Competent Authority. I would like your feedback on how to announce to the market that the device is CE marked.
For e.g. can we release a statement stating "Device XYZ has achieved/gains/obtains CE mark". As the device is not assessed by the NB, what would be the appropriate wording to announce a CE mark.
Thanks