Glossary Term
Notified Body (NB)
Definition
A Notified Body (NB) is an organization designated by a European Union (EU) member state to assess the conformity of certain products before they are placed on the market. In the MedTech industry, Notified Bodies play a crucial role in the regulatory approval process for medical devices and in vitro diagnostic devices (IVDs). They evaluate whether medical devices comply with the essential safety and performance requirements set out by the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) and issue certifications such as CE marks, allowing the devices to be marketed in the EU.
Relevance to the MedTech Industry
In the MedTech industry, Notified Bodies are responsible for ensuring that medical devices meet rigorous safety, quality, and regulatory standards before reaching the market. Their role is critical for patient safety, ensuring that devices comply with European regulations, undergo appropriate testing, and meet all relevant standards. Notified Bodies help medical device manufacturers navigate the complex regulatory landscape, provide certifications that enable market access, and ensure ongoing compliance through surveillance activities.
Additional Information & Related Terms
Key Responsibilities of a Notified Body
Conformity Assessment:
Notified Bodies assess whether medical devices meet the necessary regulatory requirements for safety and performance, as outlined in the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).
Example: A Notified Body reviews the clinical data and testing results for a new orthopedic implant to ensure it meets EU safety standards.
CE Marking:
A Notified Body is responsible for conducting the conformity assessment and issuing a CE mark for medical devices, which signifies that the product complies with EU regulations and can be sold within the European Economic Area (EEA).
Example: A CE mark is granted to a new diagnostic device after a Notified Body reviews the technical documentation and ensures compliance with applicable standards.
Audits and Inspections:
Notified Bodies perform audits of manufacturers' quality management systems (QMS), manufacturing processes, and post-market surveillance practices to ensure ongoing compliance with EU regulations.
Example: A Notified Body conducts an annual audit of a medical device manufacturer to assess their adherence to ISO 13485 and other regulatory standards.
Clinical Evaluation:
Notified Bodies assess the clinical evaluation reports of medical devices to ensure that the clinical evidence supports the device’s safety and efficacy for the intended use.
Example: A Notified Body reviews clinical trial data to verify that a new drug-eluting stent is safe and effective for use in patients.
Guidance on Regulatory Compliance:
Notified Bodies provide manufacturers with advice on regulatory requirements, helping them navigate the complexities of EU regulations and achieve compliance for market access.
Example: A Notified Body may assist a manufacturer in interpreting the EU Medical Device Regulation (MDR) for a novel device, ensuring all necessary documentation is prepared.
Related Terms
CE Marking: The certification mark provided by a Notified Body indicating that a medical device meets EU regulatory standards and can be marketed within the EU.
ISO 13485: The international standard for quality management systems for medical devices, which is often assessed by Notified Bodies to ensure manufacturing processes meet regulatory requirements.
Medical Device Regulation (MDR): EU regulation (2017/745) governing the safety and performance of medical devices, under which Notified Bodies assess and certify devices.
In Vitro Diagnostic Regulation (IVDR): EU regulation (2017/746) for in vitro diagnostic devices, under which Notified Bodies assess and certify devices for market access in the EU.
Regulatory Submission: The process through which medical device manufacturers submit their documentation and evidence of compliance to regulatory bodies like Notified Bodies for assessment and approval.