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CE Marking for Medical Devices


CE marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation.

The Medical Devices Directives set out essential requirements to ensure that a medical device will not compromise the health and safety of the patient, user or any other person, and that any risks associated with the device are compatible with patient health and protection.

Medical Devices that conform to these requirements are entitled to apply the CE Marking, which then allows the product to be freely placed on the market within the EU in compliance with the EU medical device directives.

The Competent Authority in Ireland (Irish Medicines Board) monitors and has approved the NSAI as a Notified Body to carry out the conformity assessment tasks for the following medical directives:

  • Medical Devices Directive (93/42/EEC)
    -     Annex II, Annex V and Annex VI
  • Active Implantable Medical Devices Directive (90/385/EEC)
    -     Annex II and Annex V.
  • In-Vitro Diagnostic Medical Devices Directive (98/79/EC)
    -     Annex II - List A virology products and List B products
    - Self test products
  • Human Serum Albumin Directive (2000/70/EC)
  • TSE Directive (2003/32/EC)

 

NSAI works closely with the relevant Competent Authorities and has specific expertise in providing CE Mark certification for Drug-Device Combination products

Application Review Form

3 Year Renewal Form  

Substantial Changes Document

Non- Substantial Changes Document

 




Last Updated - [23 Dec 2008 @ 12:29:20]

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