Regulatory requirements for medical devices in laboratory practice

Date

07.10.2021

Time

10.30-12.00

A place

Conference hall No. 11, Pavilion 1, IEC

PROGRAM

Classification: medical device 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

Viktoriia Shevchenko, Head of Conformity Assessment Department of the Ukrainian Scientific Institute of Certification

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