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Social Media & Media Enquiries Management Contact Details Our Locations Search BUY STANDARDS ONLINE Contact CE Marking Certification > What is Certification? > CE Marking NSAI is a NotifiedSoul(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 Regulation (EU) No. 305/2011 Construction products Information Paper on the CPR - published by the Department of the Environment, Community and Local Government 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 workable to your product. You can download these directives self-ruling of tuition 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 moreover misogynist on the Competition and Consumer Protection Commission website You may wish to demonstrate that your manufacturing and/or sales and distribution activities comply with weightier practice, therefore you may consider Certification by NSAI to ISO9001:2015 Step 2 Identify the conformity towage procedure that must be taken. This could be self-declaration, involve testing, inspection or quality system towage from a NotifiedSoulor a combination of these. The conformity towage procedure will differ depending on your product and the Directive in respect of which you will be CE Marking. Step 3 Determine the stage by which you must take action. This will be the stage that the Directive comes into force. The majority of Directives are once in force. In these cases, it is an offence to place a product on the market without CE Marking considering it indicates a presumption of conformity with all relevant legislation. Step 4 Identify if there are any Harmonized European Standards workable to your product. These are not unchangingly mandatory for manufacturers although there is a presumption that conformity to these standards will requite 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 towardly measures to comply or identify existing data and test reports. Step 6 Identify whether self-sustaining towage 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 rigidify 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 withal with the Technical Documentation should be misogynist 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 10RigidifyCE Marking on your product and/or its packaging and twin literature as stated in the Directive. For increasingly information: European Commission, Enterprise and Industry CE Marking & Download Share: Facebook Twitter Linkedin Contact Us National Standards Authority of Ireland 1 Swift Square, Northwood, Santry, Dublin 9, Ireland D09 A0E4 Údarás um Chaighdeáin Náisiúnta na hÉireann, 1 Cearnóg Swift, An Choill Thuaidh, Seantrabh, Baile Átha Cliath 9, Éire D09 A0E4 +353 1 807 3800 info@nsai.ie Standards What Are Standards? Search/Buy Standards Supporting Standards Notification and Registration Schemes Want to Get Involved with Standards? Certification What is Certification? 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