Certification of product - Conformity assessment (CE) - In-vitro diagnostic medical devices (CE)

 

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  • SERVICES PROVIDED IN CONNECTION WITH CONFORMITY ASSESSMENT OF MEDICAL DEVICES
  • Conformity assessment by Notified Body No. 1023 according to the requirements of the Council Directive 98/79/EC, laying down the technical requirements for in vitro diagnostic medical devices
    • The Applicant shall select a method of conformity assessment according to the Council Directive 98/79/EC based on categorization of in vitro diagnostic medical device
      Categories of in vitro diagnostic medical devices
      • - IVD for determining the blood groups anti-Duffy, anti-Kidd, irregular anti-erythrocytic antibodies, infections of rubella, toxoplasmosis, cytomegalovirus, chlamydia, HLA tissue groups, tumoral markers PSA, trisomy, phenylketonuria and blood sugar;
      • - IVD for selftesting.
      • - other IVD.
    • 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;
        - Type examination by the Notified Body and production quality system assessment;
        - Procedure according to the Annex No. 5 and Annex No. 7;
        - Design examination by the Notified Body for in vitro diagnostic medical device
      • Involvement of the Notified Body is not required in conformity assessment for medical devices falling under the 밢thers?category.
  • Testing in the Accredited Laboratory No. 1004 and No. 1004.3
  • 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 98/79/EC
Institute for Testing and Certification, a joint-stock company is authorized by the decision of NMZ (Czech Office for Standards, Metrology and Testing) as the Notified Body No. 1023 for conformity assessment of all in vitro diagnostic medical devices.


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CE/IVD

 

General Description

In-Vitro Diagnostic Medical Device Directive (98/79/EC) was established on December 7th, 1998. Three years and six months of grace were given from June 2000 and the directive became effective on December 7th, 2003 to all IVD devices until now.

Applicable Products

Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups;
  • ABO system
  • RH (C, c, D, E, e)
  • Anti-Kell blood type
  • Reagents and reagent products, including related calibrators and control materials, for the detection, confirma tion and quantification in human specimens of markers of;
  • HTLV I and II
  • hepatitis B, C and D
list B
  • Reagents and reagent products, including related calibrators and control materials, for determining the follow ing blood groups: anti-Duffy and anti-Kidd
  • Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
  • Reagents and reagent products, including related calibrators and control materials, for the detection and quanti fication in human samples of the following congenital infections: rubella, toxoplasmosis
  • Reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria
  • Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia
  • Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,
  • Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA
  • Reagents and reagent products, including related calibrators, control materials and software, designed specifi cally for evaluating the risk of trisomy 21,
  • The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
Self-Test
  • Annex III section 6. Design examination and legal manufacturer's declaration of conformity.
  • Annex IV complete QAS and legal manufacturer's declaration of conformity.
  • Annex V; test sample & documentation and EC type examination + Annex VI; batch product production and EC verification DoC.
  • Annex V; test sample & documentation and EC type examination + Annex VII; production quality assurance and EC verification DoC.
in-vitro devices other than specific list A, B and self-test in Annex II.
  • Annex III Quality assurance and legal manufacturer's declaration of conformity.

Conformity Assessment Procedure

Classification
Annex IX of Medical Device Directive (93/42/EEC) provides 18 rules to classify medical devices. According to these Rules, medical devices are classified by their intended purposes.
  • Rule 1 ~ 4: NON INVASIVE DEVICES
  • Rule 5 ~ 8: INVASIVE DEVICES
  • Rule 9 ~ 12: ACTIVE DEVICES
  • Rule 13 ~ 18: SPECIAL RULES
Risk value of medical devices to patient or user is identified and classified in accordance with those 18 rules. Depending on the identified risk value, conformity assessment process is decided. Higher the risk value is, stricter the conformity assessment requirements are.
With above 18 rules, medical devices are classified into class I, I-measuring, I- sterile, IIa, IIb and III.
  1. Class I medical devices follows assessment procedure Annex VII.

  2. Procedure of Class I (with measuring function)
    • Manufacturer's possible choices:
    • Technical documentation according to Sec. 3 of Annex VII and verification of the conformity with metrological requirements on each piece or on a statistically selected sample according to Annex IV
    • Technical documentation according to Sec. 3 of Annex VII and assessment of production quality system according to Annex V related to metrological requirements
    • Technical documentation according to Sec. 3 of Annex VII and quality assessment of MD according to Annex VI related to metrological requirements

  3. Procedure of Class I (with sterile)
    • Manufacturer possible choices:
    • Technical documentation according to Sec. 3 Annex VII and assessment of production quality system according to Annex V related to sterile conditions

  4. Procedure of Class IIa medical devices
    • Manufacturer's possible choices:
    • Technical documentation according to Sec. 3 of Annex VII and verification of the conformity with the technical docu mentation on each piece or on a statistically selected sample according to Sec. 8 of Annex IV
    • Technical documentation according to Sec. 3 of Annex VII and assessment of production quality system according to Sec. 6 of Annex V (by an audit at the manufacturer's sites)
    • Technical documentation according to Sec. 3 of Annex VII and assessment of medical device quality according to Sec. 6 of Annex VI (by an audit at the manufacturer's sites)
    • Technical documentation according to Sec. 3 of Annex VII and assessment of full quality system by an audit at the manufacturer's sites according to Annex II (except design examination according to Sec. 4)

  5. Procedure of Class IIb medical devices
    • Manufacturer's possible choices:
    • Technical documentation according to Section 3 of Annex III, examination of type and verification of conformity of each piece manufactured; the verification is done according to Section 5 or on a statistically (randomly) selected sample according to Section 6 of Annex IV
    • Technical documentation according to Section 3 of Annex III, examination of type and assessment of production quality system according to Annex V (by an audit of the manufacturer's sites)
    • Technical documentation according to Section 3 of Annex III, examination of type and assessment of medical device quality according to Section 6 of Annex VI (by an audit at the manufacturer's sites)
    • Technical documentation according to Section 3.2 of Annex II and assessment of full quality system by an audit at the manufacturer's sites according to Annex II (except design examination according to Section 4)

  6. Procedure of Class IIb medical devices
    • Manufacturer's possible choices:
    • Technical documentation according to Section 3.2 of Annex II, description of the design according to Section 4.2 and assessment of full quality system according to Annex II (by an audit at the manufacturer's sites)
    • Technical documentation according to Section 3 of Annex III, examination of type and verification of conformity of each piece produced; the verification is done according to Section 5 or on a statistically (randomly) selected sample according to Section 6 of Annex IV
    • Technical documentation according to Section 3 of Annex III and Section 3.2 of Annex V, examination of type and assessment of production quality system (by an audit of the manufacturer's sites)