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