Are you ready for Brexit? Do you have a Brexit contingency plan? You may need either an EU/EC European authorized representative based in EU-27 countries or a UK authorised representative (so-called "UK Responsible Person") based in UK, or may even need both EU & UK representatives, depending on different brexit scenarios. Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland). Wellkang team can help you under all Brexit scenarios! Click here to get FREE Guide Now!

AIMD-Active Implantable Medical Devices: Conformity Assessment Routes

• 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
  
• Click here to contact us for a quotation

• 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.
  Please click here to contact us. Our Wellkang team at a world leading regulatory consultancy are ready to help you!