 |
 |
 |
|||||||||||||||||||||||
   |
 |
||||||||||||||||||||||||
 |
|||||||||||||||||||||||||
 |
|||||||||||||||||||||||||
|
|||||||||||||||||||||||||
 |
|||||||||||||||||||||||||
|
|
 |
 |
|
|
||||||||||||||||||||
What is the EU/EC Declaration of Conformity for CE Marking (CE mark)?
|
|||||||||||||||||||||||||
| Are you ready for Brexit? Do you have a Brexit contingency plan?
You may need either an EU/EC European authorized representative based in EU-27 countries or a UK authorised representative based in UK, or may even need both EU & UK representatives, depending on different brexit scenarios. Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland). Wellkang team can help you under all Brexit scenarios! Click here to get FREE Guide Now! |
What is the EU/EC Declaration of Conformity for CE Marking (CE mark)?
Definition:
The EC declaration of conformity is the written statement and the a single declaration drawn up by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a product bearing the CE marking he has manufactured. The declaration shall be in respect of all Community acts applicable to the product containing all information required for the identification of Community harmonisation legislation to which the declaration relates.
This declaration must cover one or more products manufactured, clearly identified by means of product name, product code or other unambiguous reference and must be kept by the manufacturer, or his European Authorised Representative if the manufacturer is based outside the EU.
Required content (template)
for the CE marking EC Declaration of Conformity
The newest required (minumum) content for Declaration of Conformity (DoC) according to the EU Official Journal published in August 2008 are:
-----------------------------------------------------------
EC DECLARATION OF CONFORMITY
1.
No xxxxxx (unique identification of the product):
2.
Name and address of the manufacturer and/or his authorised representative:
3.
This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
4.
Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate):
5.
The object of the declaration described above is in conformity with the relevant Community harmonisation legislation: ………
6.
References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:
7.
Where applicable, the notified body ... (name, number)… performed … (description of intervention) … and issued the certificate: ….
8.
Additional information:
Signed for and on behalf of: ………………………….
(place and date of issue)
(name, function) (signature)
-----------------------------------------------------------
About CE Marking:
- Are you ready for Brexit? Wellkang can help under all Brexit scenarios!
- What is CE marking (CE mark)?
- The CE marking logo (Free download CE mark logo)
- Required content for the CE marking EC Declaration of Conformity
- What is a manufacturer? What are the responsibilities of a manufacturer?
- Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
- Why is CE marking called "European passport"?
- CE Marking Conformity Assessment Procedures according to different Modules
- Does my product need CE Marking for the European Market?
- How to obtain CE Marking for my product?
- Where can I find CE marking related publications & guidelines?
- How to distinguish EU directives?
- Where can I find CE marking testing labs nearest to my location
- Why do you need a representative in Europe?
- Why must the manufactures of medical devices appoint a EU Authorized Representative?
- Why is the Authorized Representative different from the importer/distributor ?
- Why choose Wellkang?
- How can Wellkang help you?
- What are included in Wellkangs EU Authorized Representative Service?
- 11 benefits by appointing Wellkang as your EU Authorized Representative?
- 3 unique benefits offered by Wellkang that are not available from others?
- Is Wellkang Group part of the U.S. government or EU authorities?
- How much does it cost? Competitive Price List!
- How to contact Wellkang?
About Medical Devices
- Are you ready for Brexit? Wellkang can help under all Brexit scenarios!
- Is my product a Medical Device?
- How to classify Medical Devices?
- Medical device CE Marking procedures
- Steps to obtain CE Marking for your Medical Devices
- Legal basis for medical devices
- Why must a medical device manufacture appoint a European Authorized Representative?
- Why must inform/notify/register with the Competent Authority such as MHRA?
- Who should apply/register with the Competent Authority such as MHRA?
- When to inform/notify/register with the Competent Authority such as MHRA?
- How to inform/notify/register with the Competent Authority such as MHRA?
- Cost and fees for the registration of medical devices with MHRA
- Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA
for In Vitro Diagnostic Medical Device (IVD) - Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA
for Medical Device (MD) - Role of the European Authorised Representative (Authorized Representative) in the MHRA registration
- How to change the registered details with MHRA?
- FAQs: Frequently Asked Questions about registration with Competent Authorities in Europe
- Register/Notify your Medical Device (MD) & In Vitro Diagnostic Medical Device (IVD) with MHRA-
UK Medicines and Healthcare products Regulatory Agency now! - Conformity Modules applicable for CE marking of MD and IVD Medical Devices
- All Certificates Notified Bodies can issue under the 3 medical devices directives
- Class I (including Is & Im) medical devices CE Marking procedures
- Class IIa medical devices CE Marking procedures
- Class IIb medical devices CE Marking procedures
- Class III medical devices CE Marking procedures
- IVD-In Vitro Diagnostic medical devices CE Marking procedures
- AIMD-Active Implantable medical devices CE Marking procedures
