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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. follow the procedure relating to the EC declaration of conformity set out in Annex II (full quality assurance); in this case, point 4 of Annex II is not applicable;
   or
2. follow the procedure relating to the EC type-examination set out in Annex III, coupled with:
   • (i) the procedure relating to the EC verification set out in Annex IV;
     or
   • (ii) the procedure relating to the EC declaration of conformity set out in Annex V (production quality assurance);
     or
   • (iii) the procedure relating to the EC declaration of conformity set out in Annex VI (product quality assurance).

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)

• 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?
  
• Examples of EEA/EU/UK CFS/FSC: Certificate of Free Sale (Free Sales Certificate) for Medical Device
• 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 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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