Participants had 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 discussed:
- 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
