We manufacture a Class I medical device. Can anyone please tell me where the size of the CE mark is specified?

I've seen references that it's to be 5 mm or larger, and also seen places where it says "size not specified" and I'm trying to find the standard that has the size information.

Thanks.

We manufacture a Class I medical device. Can anyone please tell me where the size of the CE mark is specified?

I've seen references that it's to be 5 mm or larger, and also seen places where it says "size not specified" and I'm trying to find the standard that has the size information.

Thanks.

Glenn,

CE Mark (http://en.wikipedia.org/wiki/CE_mark).

More about the CE Mark (http://www.berr.gov.uk/dius/innovation/regulations/cemark/page11646.html).

Stijloor.

Does anyone know the size requirements off hand?

Does anyone know the size requirements off hand?

It can be proportional.

Stijloor.

Thanks Stijloor,

That was just what I was looking for. :agree1:

Annex XII of MDD 93/42/EEC states:

The various components of the CE marking must have substantially vertical dimension, which may not be less than 5 mm.

This minimum dimension may be waived for small-scale devices.

Cool. Better yet. Thanks for the help. :cool:

Glenn

To add on from the official Council Decision 93/465/EC. Annex B(d) (http://ec.europa.eu/enterprise/faq/ce-mark.htm), the CE Guidelines are as follows -

1. The CE conformity marking must consist of the initials 'CE' taking the following form:

If the CE conformity marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

2. Where the directive concerned does not impose specific dimensions, the CE marking must have a height of at least 5 mm.

3. The CE marking must be affixed to the product or to its data plate. However, where this is not possible or not warranted on account of the nature of the product, it must be affixed to the packaging, if any, and to the accompanying documents, where the directive concerned provides for such documents.

4. The CE marking must be affixed visibly, legibly and indelibly.

Most importantly, for Class I Medical Devices (other than measuring function and sterilised product) that do not have any intervention from a Notified Body, the CE Mark should be just plain CE and MUST not carry any digit number of a Notified Body! For example, 0038. 0088 (Lloyds); 0086 (BSI); 0120 (SGS); 0123 (TUV PS); 0426 (ITALCERT), 0843 (UL, UK), etc.