EC Declaration of Conformity
Template

Courtesy of M. Devices Ltd. You are freely licensed to use
our suggested template for your EC Declaration of Conformity for
Class I, IIa, IIb & Class III devices.

Your Company name & logo

EC Declaration of Conformity (Name the conformity route chosen) to Medical Devices Directive 93/42/EEC
Manufacturer:    Your Company Name
Manufacturer's Address: Your Company Address

Device/s:  Your device/s title
Description: Describe the type of your device/s
EC Product Class:  List class/es under Annex IX rules

Declaration of Conformity

(Your Company name) declares that device/s (titles) listed on the attached Device Schedule conform/s to the relevant provisions of the EC Council Directive 93/42/EEC dated 14 June 1993 and is in accordance with (the Annex selected, EN46001 or EN46002 Quality Management System if relevant), as implemented by the European Union's Medical Devices Regulations, (any statutory Instruments) (as verified by the your named Notified Body if not a Class I non measuring, non sterile device/s).

(Your Company name) confirms that no other application has been lodged with another Notified Body for the same device related Quality Management System (if relevant).

(Your Company name) agrees to develop, implement and maintain a formally-recognised Quality Management System to ensure continued adequacy and efficacy (if relevant).

(Your Company name) agrees to develop, implement and maintain a documented post-production experience monitoring process, including the notification of reportable events under the European Medical Device Vigilance System Guidelines.

(Your Company name) confirms that no medicinal products/drugs are incorporated in any devices covered by the Device Schedule.

(Your Company name) agrees to inform the appointed Notified Body of any planned or unplanned substantial change to the Quality Management System (if relevant).

(Your Company name) agrees to inform the appointed Notified Body of any planned or unplanned significant change to the Device Schedule, including significant design change to devices (if relevant).

(Your Company name) has appointed M. Devices Ltd as our EU Authorised Representative of :

 Marlborough House, Riding Street, Southport, PR8 1EW, UK.
Tel: +44 1704 544 944 Fax: +44 1704 544 050 E-Mail : eurep@mdevices.net







Signed by the (Your Company's Name) designated representative:

Name: ____________________________________      Title: ________________________________     Date: _____________