EU Declaration Of Conformity (DOC)
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). It is required to keep signed and dated DOC for MDs / IVDs that have affixed the CE Mark (Conformité Européenne).
EU Declaration of Conformity, also known as DOC is a document in which the manufacturer declares that the Medical Device/In-Vitro Diagnostic Device complies with the requirements of MDR/IVDR and all the Union legislation applicable to the device. The DOC needs to be continuously updated by the manufacturer.
The DOC EU must be prepared as per MDR 2017/745, article 19 & annexe IV for Medical Device and IVDR 2017/746 article 17 & annex IV for Diagnostic Devices.
The DOC should be translated into an official EU language or languages required by the Member State(s) in which the device is made available. DOC should be maintained by the manufacturer for 10 years after the last device has been placed on the market and for an implantable device for 15 years after the last device has been placed on the market.
Importance of CE Declaration Of Conformity for Medical Devices
- An important part of the product’s technical documentation /technical file.
- Requires during EU Registration
- Needs at Port of Entry
- Your buyer needs it
Contents of Medical Device EU Declaration of Conformity
The following are the important contents in the Declaration of Conformity which is an integral part of the Technical Documentation for any class of device. The DOC must be in company official letterhead.
- Name and full address of the manufacturer.
- Medical Device Name.
- Brand Name ( If applicable model / variant).
- Device Risk Classification.
- List of Harmonized Standards applied.
- Declaration statement.
- European Authorized Representative Name, full address and contact information
- Notified Body name and Address (Not applicable for Class I devices).
- Name and designation of the person authorized to sign.
- Signature of authorized person.
- Date and place of signing the DOC.
Buy ready-to-use EU Declaration of Conformity Template
Easy to edit and use word files suitable for MDR & IVDR technical Files. Customers have the choice to purchase specific templates based on the class and device. The supplied documents must be edited according to suitability and specific device characteristics and standards. Customers have the choice to purchase specific templates based on the class and device. The supplied documents must be edited according to suitability and specific device characteristics and standards.
Note: Purchased templates will be sent by mail with a link to download the file within 6 hours time manually. DOC Templates are developed by an in-house team based on guidance documents and experience. No complaints and moneyback requests entertained for electronic document sale.
|MDD Class I DOC: 75 USD
Template ID: I3C-TEM-62
|MDR Class I DOC: 150 USD
Template ID: I3C-TEM-63
|MDD Class Is / Im / IIa / IIb / III DOC : 100 USD
Template ID: I3C-TEM-64
|MDR Class Is / Im / Ir / IIa / IIb / III DOC : 175 USD
Template ID: I3C-TEM-65
|IVD Class A DOC: 75 USD
Template ID: I3C-TEM-66
|IVD Class B / C / D DOC : 175 USD
Template ID: I3C-TEM-67
DOC Drafting Service as per MDR & IVDR
We develop High-Quality DOC’s for all class of device in 1-2 working days for very economic fees. Customers must provide product-specific standards.
|Class I & A||Class Is/ Im/Ir /IIa & B||Class IIb/III & D/C|
|450 Euros||650 Euros||850 Euros|
Above fees applicable for single Construction /Design