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CE Marking For Medical Devices And Other Electronic Products

CE mark on a device indicates that it meets the legal requirements as per the standards of the European Union. The abbreviation CE stands for 'Conformité Européene' which translates as ‘European Community. CE marking is a product certification marking that denotes conformity with health, safety and environmental protection standards for medical devices and other electronic products sold within the European Union.

To place a CE mark, a legal medical device manufacturer must document the device’s quality, safety and performance. Products that require CE marking are implantable medical devices, eco-design of energy related products, appliances burning gaseous fuels, cableway installations, and equipment used in potentially explosive atmosphere. We help you receive device-specific CE certification to ensure your product meets the relevant directives.

Why is CE marking important?

  • To maintain regulatory compliance.
  • To obtain approval for selling medical devices in the European Union.
  • To meet the requirements of relevant product directives.
  • To promote safety and reliability.
  • To eliminate risks and instill trust in the users.
  • Services Provided

  • Product classification assistance (Class I, IIa, IIb, and III as per the classification rules in Annex IX of the Medical Device Directive)
  • Verification of testing requirements
  • Preparation of technical and clinical evaluation report
  • Registration with the appropriate competent authorities
  • Compilation of Technical File or Design Dossier
  • Verification of compliance and review of existing marketing materials
  • Risk assessment (ISO 14971) and management
  • Assistance with post-market surveillance procedures
  • Implementation, modification, and maintenance of a quality system
  • Establishing monitoring and accident report systems
  • Issuing CE Certificate from a Notified Body
  • CE certificates issued by a Notified Body are now valid for three years and the validity period of products may vary depending on the device classification. We test and certify medical and electrical products such as external patient support products, electro-medical devices and cardiovascular catheters and help you register with the appropriate authorities in Europe. We offer guidance to prepare and maintain declaration of conformity and all related technical documentation and certificates from the Notified Body and the manufacturers and distributors have to keep the above documents for at least five years after the product has been taken out of production.