In-vitro diagnostic medical devices
ITC does not currently perform conformity assessment of in vitro diagnostic medical devices in accordance with Directive 98/79/EC of the European Parliament and of the Council on in vitro diagnostic medical devices due to termination of its validity. Currently, only appropriate surveillance of the certificates issued by it is carried out in accordance with the requirements of Article 110(3) of the new Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR). ITC is in the process of preparing the Application for Notification under the mentioned IVDR.
Links / Downloads
by the 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
- Council Directive 2006/95/EC, laying down the technical requirements for low voltage electrical equipment
- Council Directive 2004/108/EC, laying down the technical requirements for products in terms of their electromagnetic compatibility
- 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 – analyses of technical information
- 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, Inc. is notified as the Notified Body No. 1023 for conformity assessment of all in vitro diagnostic medical devices.
Ing. Tomáš Závišek
Head of department medical devices certification
Institute for testing and certification, a.s.
Medical devices certification
trida Tomase Bati 5264, 760 01 Zlin