Eu Mdr Declaration Of Conformity Template

The documents also must contain the contact details of the manufacturer the authorised representative and the notified body if applicable as well as the product details and where appropriate a reference to.

Eu mdr declaration of conformity template. Eu declaration of conformity regulation eu 2017 745 of the european parliament and. Prior to placing a device on the market manufacturers shall undertake an assessment of the conformity of that device in accordance with the applicable conformity assessment procedures set out in annexes ix to xi of eu 2017 745 medical devices regulation. The manufacturer shall continuously update the eu declaration of conformity. I know when you read the requirements this looks easy. The eu declaration of conformity doc is a mandatory requirement according to the new medical device regulation mdr and the in vitro diagnostic device regulation ivdr.

On grounds of this declaration a medical device manufacturer may attach the ce marking on the device. This is if i may say a pillar on the medical device regulation process. The eu declaration of conformity shall as a minimum contain the information set out in annex iv and shall be translated into an official union language or languages required by the member state s in which the device is made available. The doc must be drawn up in one of the official languages of the european union. Mon feb 17 00 00 00 cet 2020 created by grow ddg1 b 1 publication date.

So below is the example content. Mdr documentation submissions revision 2 may 2020 page 3 of 41. At the same time it is an assurance for doctors patients users and third parties that the particular medical device meets the existing requirements. An eu declaration of conformity doc is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the eu requirements. Mon feb 17 16 31 05 cet 2020.

The word declaration of conformity is written 38 times on the eu mdr 2017 745. N a last update. In this article i have explained how to fill a declaration of conformity in compliance with eu mdr accordingly the way manufacturer updates it. Eu declaration of conformity template proposed by ped adco document date. It is required to keep signed and dated doc for medical devices ivds that have affixed the ce mark conformité européenne.

The declaration of conformity must be kept for ten years from the date of placing the last product on the market unless the relevant ce directives provide for any other duration. It s just a document that you sign to congratulate yourself of the great job you have done and to swear that you have respected all the laws. You must refer article 19 and annex iv for eu declaration of conformity.