Navigation path


Notification

Found : 28
  Body :

National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry
Dublin 9
Country : Ireland

Phone : +353.1.807.38.00
Fax : +353.1.807.39.25

Email : info@nsai.ie
Website : www.nsai.ie

Notified Body number : 0050

Version(s): 1 2 3 4 5 6

Last update : 15/02/2011
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
Active medical devices
 
   - stimulation devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Active surgical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Anaesthetic and life support equipment
 
   - cardiovascular implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Contraceptives
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Devices containing medicinal substances
 
   - devices for infusion, injection
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - imaging equipment
 
   -
      - with non-ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Devices for wound care
 
   - disposable products
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Devices, materials and apparatus for dental treatment
 
   - Cleaning, disinfecting and sterilizing devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Medical devices incorporating stable derivatives of blood or human plasma, excluding
 
   - functional implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - imaging equipment
 
   -
      - with ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - radiotherapy devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Monitoring devices for clinical use
 
   - oxygen therapy equipment (oxygen concentrator)
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Non-active class I devices with a measuring function
 
   - Non-implantable products for orthopaedics and rehabilitation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - ophtalmological devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Surgical instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
orthopaedic implants
 
   - patient storage and transport equipment
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - soft tissue implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
Set page to normal font size Increase font size by 200 percentprint this page