Certification of product - Conformity assessment (CE) - Medical devices (CE)

We at QVC in cooperation with it’s alliance partner Institute for Testing and Certification (ITC) a.s. Zlin, NOTIFIED BODY NO. 1023 provide Services in connection with conformity assessment of medical devices

Any medical device may be introduced to the EU market only provided that an assessment of the conformity of its characteristics with the requirements laid down by Council Directive 93/42/EEC has been carried out and that the outcome of this assessment is the finding that the medical device meets the basic requirements, has been provided - except for specified exceptions - with the CE marking, satisfies the additional relevant requirements (e.g. information concerning its usage) and that the manufacturer or authorised representative has issued a written EC declaration of conformity to this effect. Institute for testing and certification is a member of TEAM-NB and is a signature of an ethics code (Code of Conduct).

  • Preliminary questionaire
  • Manual for clients
  • Application for conformity assessment
  • GFA (general framework agreement)
  • News
  • Legislation and other documents for conformity assessment

Services provided in connection with conformity assessment of medical devices

Medical devices
  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the Council Directive 93/42/EEC, laying down the technical requirements for medical devices
    • The Applicant shall select a method of conformity assessment according to the classification of the medical device:
      • quality system assessment by the Notified Body (total quality assurance system)
      • assessment of production quality management system
      • assessment of product quality management system
  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • Granting licenses for voluntary certification mark "ITC certified quality"

    ITC grants a license for the use of the quality mark, which is granted to the products where high standard of safety and quality parameters has been proved by certification and where meeting the prerequisites of the producer for continuous quality compliance has been proved through inspection visits.

  • Standardization services search for standards, analyses of technical information, borrowing of standards
  • Certification of management systems (ISO 13485, ISO 9001, ISO 14001, OHSAS 18001)
  • Technical inspectiron statistical inspections, inspection certificates

Products assessed in ITC according to the Council Directive 93/42/EEC

ce mark

Institute for Testing and Certification, a joint-stock company is authorized by the decision of ?MZ (Czech Office for Standards, Metrology and Testing) as the Notified Body No. 1023 for conformity assessment of all medical devices

If you wish to get CE certification for Medical Devices, please send us an enquiry.

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