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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