Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?

The American Chamber of Commerce in Ukraine, jointly with the member company UNI-CERT LLC, is glad to invite you to the upcoming Knowledge Webinar “Recognition of CE Certificates for Medical Devices in 2023: What You Need to Know?” scheduled for Tuesday, October 17, 11:00 AM.

Don’t miss an exceptional opportunity to learn from speakers on the main principles of assessing the conformity of medical devices through the recognition of EU certificates.

During the webinar, we will discuss:

  • 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 of the event:

Roman Mykhalko, Director UNI-CERT

Anna Telpiakova, First Deputy Director UNI-CERT

The event will be held in Ukrainian. Simultaneous translation will not be provided.

The event will be held under Chatham House rules and is open for employees of Chamber member companies only.

The event will be held in online format. The link for joining will be sent only to registered participants. Registration is required to participate. Deadline for register is Monday, October 16, COB.

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