CE Marking

"CE" is an abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". “CE Marking” on a medical device means the manufacturer's declaration that particular medical device complies with the essential requirements of the relevant European health, safety and environmental protection legislation, generally called as Product Directive
CE Marking on a medical device indicates that, it is legally placed on EU and EFTA and also ensures the free movement of the medical device within the EFTA & European Union (EU).

CE Marking Directives

• Medical Device Directive - MDD (93/42/EEC + 2007/47/EC)
  The Medical Devices applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive. Read More
• Active Implantable medical devices directive –AIMD (90/383/EEC)

  The Active Implantable Medical Devices applies to all active devices and related accessories intended to be permanently implanted in humans. Read More

• In Vitro Diagnostic medical devices directive - IVD (98/79/EC)

  The In Vitro Diagnostic medical device can be a reagent, calibrator, control material, kit or instrument used alone or in combination, for the diagnosis of patient medical condition. Read More

Principles of the CE Marking:

• The CE mark shall be affixed only by the manufacturer or his authorized representative.
• The CE mark shall be affixed only to products which requires it as per European Community law, and shall not be affixed to any other product not included.
• Indicate a product's conformity with the "essential requirements" of the directives.
• By CE marking the manufacturer declares that he takes responsibility for the conformity of the product with respect to the Directive.
• Any other marking may be affixed to the product provided thus the visibility, legibility and meaning of the CE Mark are not thereby misrepresented
• Member States shall ensure the correct implementation and take appropriate action in the event of improper use of the marking.
• CE Marking for gaining access to the EFTA & European Union market. Ensure the "free movement of goods.

Process of CE Marking of Medical Devices:

• Identify the products and models for CE Marking
• Identify the experienced consulting team
• Identify the Applicable directive
• Identify the class of medical device
• Implement Medical Device Quality Management system in your organization
• Conduct Risk analysis
• Identify the harmonized standards
• Identify the laboratories for conducting the tests
• Verify the test reports
• Prepare Technical file
• Identify the Notified Body if required
• Review of technical file
• Notified body audit
• Affix CE Mark on successful completion

More information about CE Marking can be found here >>>

Our consultants are experienced to take up any kind of complicated or rare devices. Kindly read further for more information. Any clarification please feel free to contact us.

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