Assured Confidence

CE Marking

NSAI is a Notified Body (NB) under 3 EU Directives relating to CE marking and 1 Regulation, these are:

  • 90/385/EEC Active implantable medical devices
  • 93/42/EEC Medical devices
  • 98/79/EC In vitro diagnostic medical devices

 

For a current listing of Notified Bodies by Country or Directive please consult the NANDO website

10 Steps to CE Marking (general)

Step 1

Identify the Directive/s that is/are applicable to your product. You can download these directives free of charge from the EU website: www.europa-cemarking.org

If your product does not fall under any of these Directives, 'CE' marking is not possible at present.
However, all products must comply with the provisions of the
General Product Safety Directive 2009/95/EC as transposed into Irish law by S.I. No. 199/2004.
Further information is also available on the Competition and Consumer Protection Commission website

You may wish to demonstrate that your manufacturing and/or sales and distribution activities comply with best practice, therefore you may consider Certification by NSAI to ISO9001:2008

Step 2

Identify the conformity assessment procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system assessment from a Notified Body or a combination of these. The conformity assessment procedure will differ depending on your product and the Directive in respect of which you will be CE Marking.

Step 3

Determine the date by which you must take action. This will be the date that the Directive comes into force. The majority of Directives are already in force. In these cases, it is an offence to place a product on the market without CE Marking because it indicates a presumption of conformity with all relevant legislation.

Step 4

Identify if there are any Harmonized European Standards applicable to your product. These are not always mandatory for manufacturers although there is a presumption that conformity to these standards will give conformity to the relevant part of the Directive. Whenever possible or appropriate, manufacturers should follow harmonized standards.

Step 5

Ensure the product complies with all the essential requirements of the Directive(s). Take appropriate measures to comply or identify existing data and test reports.

Step 6

Identify whether independent assessment of your conformity to the Directive, or some aspects of it, is required from a Notified Body. This will be stated in the Directive and is dependent upon the product you are CE Marking. You must not affix CE Marking to your product until all necessary certifications have been obtained from the Notified Body.

Step 7

Maintain technical documentation required by the Directive(s). Your technical documentation should support your compliance with the requirements of the Directive. It is essential to retain this documentation.

Step 8

Prepare the Declaration of Conformity and the required supporting evidence. The Declaration of Conformity along with the Technical Documentation should be available to Competent Authorities (EU Members) upon request.

Step 9

Check that no other purely national requirements exist in the countries where the product will be sold. These may include national standards, labelling or packaging requirements.

Step 10

Affix CE Marking on your product and/or its packaging and accompanying literature as stated in the Directive.

For more information:

RH Rev. 1.0
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