Notified Body - Friend or Foe in your Medical Device product journey?
Medical device software development is a delicate balance of innovation and regulation. Notified Bodies play a critical role in maintaining this equilibrium under the legislation of MDR and IVDR.
These entities are the linchpins in certifying medical devices, thereby gatekeeping device approval for European markets. No manufacturer can pass them by on the way to market access in any EU country - they need the “CE” mark.
Given their significant influence on the pathway to compliance, selecting a suitable Notified Body is a crucial step for developers in the industry to achieve a third-party conformity assessment for medical devices or diagnostical instruments.
But what exactly is a Notified Body, and how does it fit into the product journey? In this blog post, we will explore the key aspects of a Notified Body and provide insights on how to choose the right one for your medical device.
What is a Notified Body?
A Notified Body is an entity that has been accredited by a European Union Member State to assess the conformity of certain products before they can be sold within the European Economic Area (EEA). The result of a successful compliance assessment is indicated by the CE mark on products that have been assessed. The CE mark refers to the declaration of conformity of a product or the quality management system that is used to realize the product or a group of products under a defined scope.
When medical device manufacturers seek to certify their products to EU standards, these Notified Bodies are the entities they engage with to perform the necessary conformity assessment with the CE marking process. Which can have the implication that Notified Bodies hinder a manufacturer from bringing a non conformant product the European health market.
Within their responsibilities in the ce marking process, they will evaluate documentation sent by manufacturers, and verify and validate manufacturers confomity with regulatory requirements in reallife condition with on-site audit on process implementation and quality management.
Who appoints a Notified Body?
In the European Union, Notified Bodies are designated entities responsible for assessing the conformity of products that need assessment and certification by a third party, including medical devices. This appointment is made by the national competent authority of an EU Member State, often a Ministry of Health or a comparable regulatory body. These regulatory authorities evaluate and select organizations that have the necessary expertise and competence to perform these assessments effectively.
The organization that defines the regulations for selecting and evaluating Notified Bodies is the European Commission, and thus it is the central authority for the competent authorities in the EU member countries, too.
How to choose a Notified Body?
Choosing the right Notified Body is a critical decision for medical device manufacturers.
The right Notified Body depends on the scope of the quality management system of a medical device manufacturer. That scope of a QMS is defined according to the Intended Purpose of the devices that shall be brought to the market. It includes the desired impact on patient health, and the technology used with the products that are realized under the scope of the QMS.
When selecting a Notified Body, one of the most important criteria to consider is the technological expertise relevant to your product. The Notified Body must have the necessary knowledge and experience to effectively evaluate the specifications for risk management, device efficacy, equivalence with other devices, and technological state-of-the-art. This expertise is crucial in ensuring that the technical file provided by the manufacturer is thoroughly assessed for device conformity. By prioritizing the alignment of the Notified Body's expertise with the technology of your product, you can have confidence in their ability to provide a comprehensive and accurate assessment.
One useful resource for finding a Notified Body is the NANDO (New Approach Notified and Designated Organisations ) Information System of the EU Commission. The NANDO system provides a comprehensive list of Notified Bodies that have been designated by regulatory authorities.
Besides the technological expertise, there are some more aspects to watch when selecting your Notified Body for CE marking: Consider the Notified Body's relevant industry experience. Furthermore, the NB's proficiency in the latest regulatory updates and legislation changes is critical for maintaining compliance over the product lifecycle.
Engage with a Notified Body that has a broad enough accreditation scope to include also planned portfolio or market enhancements. Comprehensive expertise allows an easier conformity assessment process for both sides and better mutual understanding and leveraging regulatory nuances for successful market access.
Assess your desired Notified Body's timeline for the CE marking process. Make sure it aligns with your product launch and lifecycle management plans.
Notified Bodies can change in expertise and accredited regulatory scope which can directly impact the regulatory pathway for your medical devices. Ensure safety of your investments by regularly checking their accreditation status on the NANDO database.