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CE Marking Articles



Eaar Member
EAAR MEMBER

ISO 9001:2001
ISO 9001:2001

MDD 93/42/ECC Article 4.4 excerpt

 
4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.

for a complete copy of the Directive, click here


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