A Notified Body is a government-supervised organization designated by a member state of the European Union to test the suitability of various products before they are placed on the market. The European Commission also maintains a database of Notified Bodies called Nando (New Approach Notified and Designated Organisations). In medical technology, they are also responsible for evaluating the conformity assessment of medical devices. During the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), they issue the certificates of the tested products.
Certificates are the official written confirmations from Notified Bodies that a product may be placed on the market. After a conformity assessment, they may be issued for up to five years. Certificates are the official written confirmations issued by Notified Bodies, demonstrating that a product may be placed on the market. Following a successful conformity assessment, certificates can be issued for a period of up to five years. After a thorough review, they may be renewed for an additional five-year period.
This article explains the role of Notified Bodies, the content and requirements of certificates, and important considerations regarding collaboration between Notified Bodies and medical device manufacturers in the context of UDI registration in EUDAMED.
Responsibilities of Notified Bodies
As independent third parties, Notified Bodies are required to act impartially and conduct conformity assessments to the best of their knowledge and professional judgment. Their primary responsibility is to assess product conformity.
This includes:
- Reviewing technical documentation
- Assessing individual products and product types
- Auditing and certifying quality management systems
- Conducting unannounced audits
However, ultimate responsibility for compliance with the MDR and IVDR always remains with the manufacturer.
Notified Bodies in EUDAMED Practice
EUDAMED entries are also reviewed during audits and technical documentation assessments. Notified Bodies typically verify whether:
- the manufacturer is correctly registered in EUDAMED and has obtained a Single Registration Number (SRN);
- the manufacturer and, where applicable, authorized representative information matches the audit documentation;
- the registered Basic UDI-DIs correspond to the certified products;
- the certificates and product data referenced in EUDAMED are plausible and consistent; and
- changes to products or organizational information have been appropriately updated in EUDAMED.
The approval process carried out by the Notified Body itself can also present practical challenges for manufacturers. Certain UDI records in EUDAMED must first be approved by the Notified Body responsible before the registration process can be completed.
In practice, manufacturers often encounter the same situation: UDI data is registered and initially appears to be fully compliant. However, shortly before the process is finalized, the Notified Body may return with questions or requests for corrections. For example, a certificate may not be linked due to inaccurate information, or a specific field may not have been completed according to the Notified Body’s internal requirements.
How Can Manufacturers Meet Notified Body Requirements?
Manufacturers are advised to test the EUDAMED structure in the Playground environment and coordinate with their Notified Body at an early stage. Entering a small number of representative products is usually sufficient to identify potential inconsistencies before large-scale registration begins.
This additional validation step can be particularly valuable for manufacturers with extensive product portfolios. Subsequent changes to registered Basic UDI-DIs are often time-consuming and resource-intensive because modifications to a Basic UDI-DI generally affect all associated UDI-DIs.
Manufacturers should also consider that coordination with a Notified Body may require additional time. Companies that delay registration activities until shortly before regulatory deadlines risk unnecessary time pressure. It is therefore recommended to start planning and uploading UDI data to EUDAMED as early as possible, allowing sufficient time for testing, corrections, and review cycles.
The following step-by-step approach can help manufacturers create UDI entries that comply both with EUDAMED business rules and the expectations of Notified Bodies:
- Verify that all data fully complies with EUDAMED business rules. The easiest way to do this is with our automatic check in the mytracekey UDI Manager.
- Use the EUDAMED Playground and enter a selection of UDI records. Depending on the number of different products and data types, at least one registration per product or data type is recommended. You can submit data to EUDAMED, whether in the playground or production environment, using our UDI software via XML bulk upload or the M2M connection.
- Ask your Notified Body to review the data in the Playground and confirm its correctness.
- Only after receiving confirmation should, you proceed with the final registration of all UDI records in the EUDAMED Production environment.
Certificate Requirements
The requirements for certificates are specified in Annex XII of both the MDR and IVDR.
Among other requirements, each certificate may only be issued to a manufacturer for a specific conformity assessment procedure. Notified Bodies must therefore be able to demonstrate which products are covered by a particular certificate. Any amendments or supplements to certificates must clearly reference the original certificate.
Certificates must contain at least the following information:
- Details of the Notified Body
- Details of the manufacturer or authorized representative
- Unique identification number
- Manufacturer registration number
- Date of issue
- Expiry date
- Information enabling the unique identification of the product
- Reference to the regulation under which the conformity assessment was performed
- Results of the conformity assessment
Conformity Assessment
Since manufacturers may only place products on the market if they meet the applicable regulatory requirements, conformity assessment is an essential process. Products are tested and evaluated to determine whether they comply with the relevant requirements and may subsequently receive certification.
This process helps ensure that only safe products are available on the European market.
Because the MDR and IVDR cover a broad range of product types, different conformity assessment procedures apply depending on the product category and risk class. Detailed requirements for these procedures are defined within the respective regulations.
For Class I medical devices, conformity assessment is generally carried out by the manufacturer. For devices in higher risk classes, however, the involvement of a Notified Body is required to assess and verify compliance.
tracekey solutions supports you with UDI registration in EUDAMED, swissdamed, AusUDID and GUDID. Please feel free to contact us to find the right package for your UDI registration.
[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: August 2026)