Certification of product - Conformity assessment (CE) - Active implantable medical devices (CE)

 

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  • SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF ACTIVE IMPLANTABLE MEDICAL DEVICES
  • Conformity assessment by the Notified Body No. 1023 according to the requirements of the Council Directive 90/385/EEC, laying down the technical requirements for active implantable medical devices.
    • The Applicant shall select the method of conformity assessment in accordance with the Government Order  the Council Directive 90/385/EEC
    • Conformity assessment procedures
      • Quality system assessment by the Notified Body  (total quality assurance system);
      • Type examination by the Notified Body and verification of conformity with the certified type
  • Accredited Laboratory No. 1004 and No. 1004.3
  • Technical inspection - statistical Granting licences for the 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.Certifikace
  • 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 inspection - statistical inspections, inspection certificates
  • PRODUCTS ASSESSED IN ITC ACCORDING TO the Council Directive 90/385/EEC
Institute for Testing and Certification, a joint-stock company is notified for conformity assessment of active implantable medical devices in full scope of the Council Directive 90/385/EEC.


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CE/AIMD

 

General Description

In respect of active implantable medical devices, certification of devices subject to the directive (AIMDD, 90/385/EEC) began on 1 January 1995 and has been mandatory from June 14, 1998 until now.

Active implantable medical device means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Applicable Products

  • Implantable feeding pump for medicine.
  • Implantable pulse generator for pacing with/without the electrode
  • Implantable hearing aids
  • Electrode
  • Implantable drug administration device with or without catheter
  • Catheter for implantable drug administration device
  • Implantable pulse generators (IPG) and Defibrillators (ICD)

Conformity Assessment Procedure

  1. Assessment procedures
    AIMD directive lays down several different conformity assessment procedures. Manufacturer(s) shall select a conformity assessment procedure that suits the most among the annexes 2, 3, 4 and 5 of the directive, AIMDD, 90/385/EEC.

  2. Essential requirement
    In brief the essential requirements state that safety and performance must be documented, and that potential side effects and risks must be described. The manufacturer must also have performed an analysis, showing that the benefits of the device are considered to outweigh the side effects.

  3. Quality management system
    In case the manufacturer chooses conformity assessment procedure including quality system, the manufacturer shall make an application for evaluation of his quality system to a notified body

  4. Examination of the design of the product
    Manufacturer shall make an application for examination for the design dossier relating to the product which he plans to manufacture. The application shall describe the design, manufacture and performances of the product in question, and it must include the document assessment whether the product conforms to the requirements of the directive, AIMDD, 90/385/EEC.

  5. Assessment and certification approval
    Assessment is conducted based on Annexes 2, 3, 4, and 5 of the Directive 90/385/EEC on active implantable medical devices.
    If the results of the assessment including audit are positive, you receive an approval for the conformity assessment procedure. This is followed by a regular surveillance audit every 12 months and recertification every 5 years by the notified body.

  6. Declaration of conformity
    Upon successful completion of the assessment, a manufacturer can issue the declaration of conformity for his product(s) and market them with the CE mark.