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Recognition of CE certificates in 2023: extension of MDD certificates until the end of 2028, recognition of MDR

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  • Recognition of CE certificates in 2023: extension of MDD certificates until the end of 2028, recognition of MDR
Date

22.09.2023

Time

11.00-12.00

A place

Online streaming

Issues for discussion:

  • Changes to the requirements for documents regarding the introduction into circulation and/or operation of medical devices during martial law
  • Consequences of postponing the entry into force of Regulation (EU) 2017/745 (MDR)
  • Legal basis of the recognition procedure and necessary conditions
  • List of required documents
  • Step-by-step conformity assessment by recognition of the EU certificate
  • Validity of the certificate issued by recognition and other restrictions
  • Performing surveillance audits for certificates issued by recognition
  • Extending the validity period of MDD certificates

Speakers:

Roman Mykhalko, Director UNI-CERT

Anna Telpiakova, First Deputy Director UNI-CERT

You can register and ask your questions here: https://forms.gle/ep16pJhzstRmGHTp9

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