COVID-19 Information View NSAI's updates and resources in relation to the COVID-19 pandemic CLICK HERE BUY STANDARDS ONLINE CONTACT CE Marking CERTIFICATION > WHAT IS CERTIFICATION? > CE MARKING NSAI is a Notified Body (NB) under the following EU directives and regulations only: 90/385/EEC Active implantable medical devices 93/42/EEC Medical devices 98/79/EC In vitro diagnostic medical devices Regulation (EU) No 305/2011 - Construction products Regulation (EU) 2017/745 on medical devices 2014/31/EU Non-automatic weighing instruments 2014/32/EU Measuring Instruments Directive Information Paper on the CPR - published by the Department of the Environment, Community and Local Governme CE marking of Construction Products - Step by Step guide - published by the European Commission For a current listing of Notified Bodies by Country or Directive please consult the NANDO website Information from the European Union on Selling Products in the EU. 10 Steps to CE Marking 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 ISO9001:2015 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. A list of Notified Bodies and the directives they are notified for can be found on the NANDO Website. 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: European Commission, Enterprise and Industry CE Marking & Download SHARE: National Standards Authority of Ireland 1 Swift Square, Northwood, Santry, Dublin 9, Ireland D09 A0E4 +353 1 807 3800 info@nsai.ie Sitemap Privacy Notice Accessibility Cookies Settings Copyright © 2021 NSAI We rely on your consent to use cookies that enhance the performance of our site and our marketing effortsRead our Cookie Policy Cookies Settings Reject All Accept All