Demystify Series: Getting CE Mark for Medical Devices from India

  1. Why do you need CE Marking ?
  • Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC), or Active Implantable Medical Devices Directive (90/385/EEC).
  • Determine the classification of your device.
  • Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
  • Prepare a CE Marking Technical File or a Design Dossier.
  • Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR).
  • Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
  • Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile, and has no measuring function.
  • Obtain CE Marking and ISO 13485 certificates from your Notified Body.
  • Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.
  • First you need to make a list of Notified Bodies based on the product codes they are authorised to conduct audits on. See how many of them are qualified to conduct audit on your medical device.
  • Secondly request for a meeting/call to discuss the device with each one of them.
  • Get a quote and compare from each Notified Bodies qualified for your type of medical device.
  • Select the Notified body based on their 1) Past experience in auditing and approving similar devices 2) Their Location- Ask if they have auditors based out of India to conduct audit. If Auditors need to come from Europe, cost can significantly rise. 3) Check their reputation in the market- Easiest way is to ask your Distributors/Customers. 4) Budget- This can also be negotiated based on how much man days they need to allocate for the audit.
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Leo Mavely

Leo Mavely

Founder Axio Biosolutions, Medtech, Healthcare