"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.