We frequently discuss medical device registration in Brazil. In this context, it's important to highlight that while in Brazil a device can only be commercialized after obtaining registration with ANVISA, in the European Union the equivalent authorization is called CE (European Conformity) marking, granted by a Notified Body.
A Notified Body is an organization designated by an EU Member State, or by other countries with specific agreements, to assess the conformity of certain products before they are placed on the European market. These bodies are authorized to carry out conformity assessment procedures provided for in the applicable legislation, whenever third-party intervention is required.
For an organization to be designated as a Notified Body, it must meet stringent requirements related to its organizational structure, quality management system, resources, and internal processes. Verification of these requirements is carried out by the responsible national authorities, with the participation of European experts. After designation, the European Commission publishes the list of Notified Bodies in the New Approach Notified and Designated Organizations Information System (NANDO), which can be filtered according to the applicable regulation, such as Regulation (EU) 2017/745 for medical devices (MDR) or Regulation (EU) 2017/746 for in vitro diagnostic devices (IVDR).
Notified Bodies are continuously monitored by national authorities, who prepare and make public annual summary reports on monitoring activities and on-site audits. Furthermore, Notified Bodies must publicly disclose their lists of standard fees for the conformity assessment activities they perform.
To harmonize practices and promote alignment among the different bodies, there is the Notified Body Coordination Group (NBCG-Med), a coordination group that operates specifically in the field of medical devices, as provided for in the European MDR and IVDR regulations.
Despite this, each Notified Body specializes in specific types of medical devices, making it crucial to choose the one with adequate expertise for your product. Even while following the same European legislation (such as the MDR or IVDR), each body evaluates processes in its own way, and within each body, each reviewer may have their own particularities in the analysis.
This means that requirements and requests may vary according to the Notified Body and the responsible reviewer, making it important to carefully choose the most suitable body and prepare the dossier completely and consistently to minimize additional requests.
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