Steps for Class I medical devices compliance

1. Classification: ensure the device is a Class I medical device.
2. Choose Conformity Assessment Route: refer the flow chart below.
3. Compile the Technical File.
4. Declaration of Conformity.
5. Appoint an Authorised Representative. (register with the Competent Authority)
6. Vigilance and Post Market Surveillance. (affix CE marking & market the products)

Class I Medical Devices: Conformity Assessment Routes

The conformity assessment routes for Class I Medical Devices

1. The manufacturer is responsible for ensuring that his product complies with all the relevant Essential Requirements of the Directive and must draw up a written statement to this effect (self-declaration).
   
   
2. Class I Medical Device without a measuring function and supplied in non-sterile condition does NOT require the involvement of a Notified Body. Conformity to the International and European Standard EN ISO 13485 is voluntary.
   
   
3. Manufacturers of sterile products and devices with a measuring function must apply to a Notified Body for certification of the aspects of manufacture relating to sterility or metrology.
   
   
4. Once the manufacturer is satisfied that his products meet all the relevant Essential Requirements, the manufacturer, or his European Authorised Representative if the manufacturer is located outside of EEA, must register with the Competent Authority (CA). He may then affix the CE marking on his products and place them on the EEA market.

• 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
  
• 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
• 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!