Steps for Class IIb medical devices compliance

1. Classification: ensure the device is a Class IIb medical device.
2. Choose Conformity Assessment Route: refer the flow chart below.
3. Compile the Technical File.
4. Obtain certification from a Notified Body
5. Declaration of Conformity.
6. Appoint an Authorised Representative. (Hold the Tech Files for inspection by the Competent Authority)
7. Vigilance and Post Market Surveillance. (affix CE marking & market the products)

Class IIb Medical Devices: Conformity Assessment Routes

The conformity assessment routes for Class IIb Medical Devices

1. a Notified Body must carry out either an Annex II audit of the full quality assurance system (ISO 13485:2003), or
2. a type-examination (Annex III) plus one of the three options given here:
   • Examination and testing of each product or homogenous batch of products (Annex IV); or
   • Audit of the production quality assurance system (Annex V:) ISO 13485:2003 (excluding Design) or
   • Audit of final inspection and testing (Annex VI:) ISO 13485:2003 (excluding Design & Manufacture)

• Is my product a Medical Device (MD) or In Vitro Diagnostic Medical Device (IVD)?
  
• How to classify Medical Devices (MD)?
• Which category does an In Vitro Diagnostic Medical Device (IVD) fall into?
• Why must a medical device manufacture appoint a European Authorized Representative?
  
• Why must inform/notify/register with the Competent Authority?
  
• When to inform/notify/register with the Competent Authority?
  
• Who should apply/register with the Competent Authority?
  
• Changes to registered details?
  
• 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
  
• Medical device CE Marking procedures
  
• Steps to obtain CE Marking for your Medical Devices
  
• Legal basis for medical devices
  
• Cost and fees for the CE Marking of Medical Devices
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• Why choose Wellkang?
• How can Wellkang help you?
• What are included in Wellkangs EU Authorized Representative Service?
• 11 benefits by appointing Wellkang as your EU Authorized Representative?
• 3 unique benefits offered by Wellkang that are not available from others?
• Why do you need a representative in Europe?
• Why is the Authorized Representative different from the importer/distributor ?
• 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?
  
• How to distinguish EU directives?
  
• Where can I find CE marking testing labs nearest to my location
  
  
• For more information, please visit our Questions and Answers section.
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