Essentials of European Medical Device Regulatory Affairs
Stakeholders updates
Notified Body
Commission & MDCG
NB must be designated under MDR or IVDR prior to providing quote for conformity assessment services to Regulations Designation process takes approximately 18 months after Joint Assessment Several NBs have withdrawn from the business under the Directives
Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices MDCG have met and are working on implementation items
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Nando database (06 th January 2020):
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• 55 NB’s under MDD and 21 NB’s under IVDD • 9 NB’s under MDR and 3 under IVDR
The Organisationfor Professionals inRegulatory Affairs
Module 3
• Medical Device definitions and MDR Classification • Medicinal Products and Borderline Products • Combination/integral products
The Organisationfor Professionals inRegulatory Affairs
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