Medical devices in the nomenclature of pharmaceutical manufacturers. Conformity assessment of in-vitro diagnostic medical devices





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Devices at the border of definitions:

  • medical devices supplied with the medicinal product;
  • medical devices as a means of drug delivery;
  • devices, an integral part of which is a medicinal product;
  • devices for IVD, RUO (research use only) and general laboratory equipment.

Conformity assessment through self-declaration.

Conformity assessment performed by conformity assessment body:

  • choosing the best procedure for your business;
  • application and documentation;
  • step-by-step description of the conformity assessment procedure through an audit of the manufacturing facilities;
  • special procedure for III class devices, which incorporate medicines;
  • requirements for instruction for use and labeling.

Conformity assessment of medical devices through the recognition of EU certificates:

  • the legislative basis of the recognition procedure and the necessary conditions;
  • list of required documents;
  • step-by-step implementation of the conformity assessment by recognition of EU certificate;
  • the validity period of the certificate issued by recognition and other restrictions.

Declaration of conformity.

Conducting of surveillance audits for issued certificates.

Nikolay Matlaev, The lead auditor on certification of quality management systems and conformity assessment with technical regulations of the Ukrainian Scientific Institute of Certification

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