CE Mark Labeling Requirements for a Class II Medical Device

[Dylansnow]

Is it mandatory to have the Manufactured symbol and date of manufacture on a CE marked class IIa device that has an expiry date. The expiry date is will be displayed.

Regards

Dylan

[pkost]

In short...No it isn't necessary


ER13.3(l) states: year of manufacture for active devices other than those covered by
(e). This indication may be included in the batch or serial number;

(e) states: where appropriate, an indication of the date by which the device
should be used, in safety, expressed as the year and month;




You specify a useby date so therefore you are ok not to include the manufacture date.

[Alexisss]

It depends on your product.

You shall place date of manufacture if the product is aging and its properties are affected as time passes during storage. For example, products containing natural rubber or adhesives or sterile packaging.

Even for rubber products, it is a delicate issue because it is different when you have medical gloves, for example, and different when you have a rubber part in a product.

[Dylansnow]