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services to Regulations Designation process takes approximately 18 months after Joint Assessment Several NBs have withdrawn from the business under the Directives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

Nando database (06 th January 2020):

• 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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