Selection of a Notified Body and Their Process for your new device authority

 

Notified Bodies an overview: 

A Notified Body is a third-party organization that has been approved by an EU member state to judge whether manufacturers adhere to the relevant legislation. With such a crucial role, choosing a Notified Body and your partnership’s working relationship are crucial to getting your CE marking. As CE marking medical device consultant, we know the criticality of selecting the Notified body and hence we work with right notified bodies to get the compliance. 

Selection of a Notified Body and their Process: 

Not only medical device manufacturer has had to adapt to the new European Union In Vitro Diagnostic Regulation and the European Union Medical Device Regulation (EU MDR) (IVDR). Only 30 NBs have been recognized under EU MDR as a result of the new regulations’ need that Notified Bodies go through a new designation and notification process. And the EU IVDR has only designated seven NBs. Because there are fewer NBs, those who are designated under MDR and IVDR will only be able to handle a certain number of new conformity assessment applications. 

Role of Notified body: 

Show your notified body you understand your obligations under MDR- 

The general obligations of manufacturers are covered by Article 10 of the MDR. The NB will carefully examine how you’re handling these requirements during an audit. They will want to ensure that you are adhering to the MDR criteria when they examine your QMS structure. For instance, are your risk management, clinical evaluation report (CER), post-market surveillance (PMS), and technical documentation all related?  

The NB will also examine how you’ve implemented your contractual agreements with different Economic Operators (EOs). How did you handle the MDR requirements for your EOs? This entails demonstrating to them your communication, procedures, supplier audits, and other compliance-related activities. This is not a comprehensive list of questions or things your NB will want to see, but it should make you consider how prepared you are for these types of queries.

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