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

Share this:

Other news

21.06.2020

Features of the production of sterile medical devices. Clean rooms.

PharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian

Read more
23.02.2021

A contract on recognition of the results of the assessment of conformity with Polish Centre for Testing and Certification (1434)

We are pleased to inform you that the notified body Polish Centre for Testing and Certification (1434) has signed an arrangement for the recognition of conformity assessment results with the UNI-CERT LLC. Due to this collaboration, our clients can significantly reduce their time and financial expenses for certification of their products in Ukraine. We have already accumulated sufficient […]

Read more
25.06.2020

Features of the classification. Medical devices on the border of definitions.

PharmaTechExpo Journal №1-2, 2020. The text of the article is available only in Ukrainian

Read more