Essentials of European Medical Device Regulatory Affairs - October 2019
Registration EOs
EO database (Article 30): For manufacturers, authorized representatives and importers: EOs Submit information per Section 1 of Annex VI Part A Competent Authority verifies data and issues Single Registration Number (SRN) Registration before placing the device on the market For Class III and Class IIb implantable devices SRN
must be obtained prior to NB assessment Changes - EO must update within 1 week Competent Authority can charge a fee
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Module 6
• Device labelling
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