What is a Notified Body?
A Notified Body (NB) is an entity accredited by the Competent Authority of a European Union (EU) Member state to act as a third party assessor of manufacturers’ compliance with applicable EU regulation for certain products prior to market entry.
A Notified Body governs the CE marking process by assessing the conformity of medical devices and In Vitro Diagnostics devices with the appropriate directive – either the European Medical Devices Directive (MDD) 93/42/EEC, the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC or the In Vitro Diagnostics Directive (IVDD) 98/79/EC. The EU is currently transitioning to new regulations: EU 2017/745 (MDR) to replace both the MDD and the AIMDD, and the EU 2017/746 (IVDR) to replace the IVDD. Under these new regulations, Notified Bodies will perform conformity assessment based on the quality management system and assessment of the technical documentation, type examination, or product conformity verification.
How do I approach a notified body?
Manufacturers may choose the Notified Body with which they wish to work when assessing their products’ compliance with EU regulations. As the relationship with a Notified Body can make or break a company, companies should choose their Notified Body wisely.
Each Notified Body is authorized to audit specific industry segments and product classes; thus, it is important to understand its expertise and choose a Notified Body with a specialty that matches your company’s products. When approaching a Notified Body, it is important to understand that it acts as an independent third-party organization subject to regular reviews by the Competent Authority. Additionally, Notified Bodies are commercial entities, therefore, their services cost money.
Where third-party accreditation is required, a company must discern which Notified Bodies have the expertise and authority to audit its product. The company would then correspond with the NB and obtain price quotes prior to making the most suitable decision. The EU publishes an official list of authorized Notified Bodies which is available on the NANDO website
How can we help?
As an experienced Quality Assurance (QA) and Regulatory Affairs (RA) consultant, Li-Med maintains longstanding relationships with various Notified Bodies. We are familiar with their specializations and are able to direct our clients to the Notified Body most appropriate for their products.