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IVD-In Vitro Diagnostic Medical Devices: Conformity Assessment Routes

1. For all devices referred to in List A in Annex II
   other than those intended for performance evaluation, the manufacturer shall, in order to affix the CE marking either:
   • (a) follow the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance),
     or
   • (b) follow the procedure relating to EC type-examination set out in Annex V coupled with the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).
     
     
2. For all devices referred to in List B in Annex II
   other than those intended for performance evaluation, the manufacturer shall for the purposes of affixing the CE marking, follow either:
   • (a) the procedure relating to the EC declaration of conformity set out in Annex IV (full quality assurance)
     or
   • (b) the procedure relating to EC type-examination set out in Annex V couplet with:
     
     (i) the procedure relating to EC verification set out in Annex VI,
     or
     (ii) the procedure relating to the EC declaration of conformity set out in Annex VII (production quality assurance).
     
     
3. Other than those covered by Annex II
   
   
   • Self-testing
     For all devices for self-testing other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, prior to the drawing up the EC declaration of conformity in Annex III, fulfill the supplementary requirements set out in Annex III, point 6. Instead of applying this procedure, the manufacturer may follow the procedure referred to for products in List A or List B in Annex II.
     
     
   • Other/General
     For all devices other than those covered by Annex II and devices for performance evaluation, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex III and draw up the EC declaration of conformity required before placing the devices on the market.
     
     
4. In the case of devices for performance evaluation, the manufacturer shall follow the procedure referred to in Annex VIII and draw up the statement set out in that Annex before such devices are made available.
   
   This provision does not affect national regulations relating to the ethical aspects of carrying out performance evaluation studies using tissues or substances of human origin.
   
   

• Are you ready for Brexit? Wellkang can help under all Brexit scenarios!
  
• Is my product a Medical Device?
  
• How to classify Medical Devices?
• Medical device CE Marking procedures
  
• Steps to obtain CE Marking for your Medical Devices
  
• Legal basis for medical devices
  
• Why must a medical device manufacture appoint a European Authorized Representative?
  
• Why must inform/notify/register with the Competent Authority such as MHRA?
  
• Who should apply/register with the Competent Authority such as MHRA?
  
• When to inform/notify/register with the Competent Authority such as MHRA?
  
• How to inform/notify/register with the Competent Authority such as MHRA?
  
• Cost and fees for the registration of medical devices with MHRA
• Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA
  for In Vitro Diagnostic Medical Device (IVD)
• Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA
  for Medical Device (MD)
• Role of the European Authorised Representative (Authorized Representative) in the MHRA registration
  
• How to change the registered details with MHRA?
  
• FAQs: Frequently Asked Questions about registration with Competent Authorities in Europe
  
• Register/Notify your Medical Device (MD) & In Vitro Diagnostic Medical Device (IVD) with MHRA-
  UK Medicines and Healthcare products Regulatory Agency now!
• Conformity Modules applicable for CE marking of MD and IVD Medical Devices
  
• All Certificates Notified Bodies can issue under the 3 medical devices directives
  
• Class I (including Is & Im) medical devices CE Marking procedures
  
• Class IIa medical devices CE Marking procedures
  
• Class IIb medical devices CE Marking procedures
  
• Class III medical devices CE Marking procedures
  
• IVD-In Vitro Diagnostic medical devices CE Marking procedures
  
• AIMD-Active Implantable medical devices CE Marking procedures
  
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• Why do you need a representative in Europe?
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• Classification: how to classify Medical Devices?
  
  

• What is CE marking?
  
• The CE marking logo
  
• What is a manufacturer?
  
• Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer?
  
• Why is CE marking called "European passport"?
  
• Does my product need CE Marking for the European Market?
  
• How to obtain CE Marking for my product?
  
• Where can I find CE marking related publications & guidelines?
  
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