Medical Device -Declaration of Conformity for CE Marking

A Declaration of Conformity (DOC) is a declaration made by the manufacturer of Medical Device that, Medical Device is in conformity with the Essential Requirements of the European Medical Device Directive (93/42/EEC). All manufacturers of medical devices whether  self-declare or require Notified Body must prepare a DOC, a legally binding document that should be signed by Authorized Representative. It should be in the company letterhead and the DOC must be written in one of the official language of the European Union.DOC is mandatory in the technical file preparation for CE Marking

The declaration of conformity for CE Marking must contain the following;

• Name of the Medical Device
• Class and rule of the Medical Device that mentioned  the directive.
• The name and address of the manufacturer and, the name and designation of the representative
• The issue date of the declaration
• CE Mark with the number of Notified Body
• Name of the  Notified Body ( if applicable)
• EU representative name and contact details
• The list the directives and standards that your Medical Device conforms to product identification
• CE Certificate number ( if applicable)
• The list of Medical Devices covered in the Declaration of conformity

Malesh M

Regulatory Consultant

 I 3 Consulting

+91 9900 3218 14