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 events

20.10.2021

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

PROGRAM 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 […]

Read more
07.10.2021

Certification of medical device manufacturing by pharmaceutical companies

PROGRAM Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies: medical devices supplied with a medicinal product medical devices for drug delivery products that are integral with the medicinal product products for IVD, RUO (research use only) and general laboratory equipment medical / cosmetic / hygienic purpose of products aids (accessories) Requirements of […]

Read more