A Notified Body (NB) is a private organization officially designated by an EU Member State government to perform conformity assessment tasks for certain products sold in the European market. These organizations act as third-party gatekeepers, verifying that medium and high-risk medical devices meet the necessary safety, health, and performance requirements set out by European Union law. The manufacturer must successfully engage with an NB to obtain the necessary certification, which is a mandatory step for market access for the majority of medical technology.
The European Regulatory Environment
The Notified Body system is central to the legal framework established by the European Union for medical devices, specifically under the Medical Device Regulation (MDR) (EU Regulation 2017/745) and the In Vitro Diagnostic Regulation (IVDR) (EU Regulation 2017/746). This regulatory structure mandates that most devices cannot be legally placed on the market without the involvement of one of these designated third-party assessment bodies. The goal of this framework is to protect public health by ensuring a high level of safety and quality across all medical technology sold within the European Economic Area.
The involvement of a Notified Body hinges on a device’s risk classification, which ranges from Class I (low risk) to Class III (high risk). Low-risk devices, such as non-sterile examination gloves, are typically Class I and can be self-certified by the manufacturer through a Declaration of Conformity. However, any device classified as Class IIa, Class IIb, or Class III, including all implantable devices, requires a full conformity assessment by an NB.
In vitro diagnostic medical devices (IVDs) are also subject to this tiered system, though they are classified differently, ranging from Class A (low risk) to Class D (high risk). Under the IVDR, a much larger proportion of these diagnostic products, including all Class B, C, and D devices, now require Notified Body oversight.
Upon successful completion of the assessment, the Notified Body issues a certificate, which allows the manufacturer to affix the CE marking to the device, signifying its conformity to the applicable EU regulations. This model of using independent third-party certifiers contrasts with systems like that of the US Food and Drug Administration (FDA), where pre-market approval is granted directly by the government agency.
Primary Functions in Device Certification
The operational tasks performed by a Notified Body focus on two main areas: the manufacturer’s internal processes and the device’s specific technical documentation. The NB’s first major function involves an in-depth audit of the manufacturer’s Quality Management System (QMS). This QMS audit verifies that the structured set of policies and procedures complies with the requirements of the MDR or IVDR and generally aligns with recognized international standards like ISO 13485.
These audits are not a one-time event but include scheduled surveillance audits and the possibility of unannounced inspections during the certificate’s validity to ensure continuous adherence to quality standards. The review confirms the manufacturer has robust controls over design, production, labeling, post-market surveillance, and the management of device risk. A satisfactory QMS audit is a prerequisite for a manufacturer to proceed with device-specific certification.
The second primary function is the rigorous review of the device’s Technical Documentation, often referred to as the Technical File. This comprehensive file contains all the data that proves the device meets the General Safety and Performance Requirements (GSPR) outlined in the regulations. This evidence includes engineering drawings, risk management files, sterilization validation reports, and clinical data evaluation.
For Class III and certain high-risk devices, the Notified Body may require a specific review of the device’s Clinical Evaluation Report (CER), which systematically analyzes the clinical data available. Once both the QMS and the Technical Documentation are deemed compliant, the NB issues a CE certificate, which is typically valid for a maximum of five years. The NB holds the authority to maintain, restrict, suspend, or withdraw this certificate if subsequent surveillance activities reveal non-conformities or new safety concerns.
How Notified Bodies Are Approved and Monitored
The competence and impartiality of a Notified Body are secured through a stringent designation and ongoing surveillance process. Any organization wishing to become an NB must first submit a formal application to the Competent Authority of the Member State in which it is established. This Competent Authority, the national body responsible for enforcing medical device law, then begins the rigorous assessment of the applicant.
The designation assessment is not carried out by the national authority alone but involves a joint team of experts from the European Commission and other Member States. This joint audit team evaluates the applicant’s expertise, impartiality, resources, and technical competence. The organization must demonstrate that it has permanently available staff with appropriate technical, scientific, and clinical expertise relevant to the specific types of devices it intends to certify.
If the assessment is successful, the Member State officially designates the organization as a Notified Body and publishes its details in the European Commission’s NANDO (New Approach Notified and Designated Organizations) database. This publication includes its specific scope of qualification, which defines the precise device codes and conformity assessment procedures the NB is authorized to perform. The designating Competent Authority is then responsible for the continuous monitoring and surveillance of the Notified Body throughout its operational life.
This ongoing oversight includes regular on-site monitoring audits to ensure the NB maintains the organizational structure, independence, and expertise required for its designation. The Notified Body is required to report regularly to its Competent Authority on all certificates issued, modified, or withdrawn, ensuring a high level of transparency.