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. In addition, it is possible to extend the certificate for a further five years after a thorough examination. Exactly what tasks the Notified Bodies perform, what the content of the certificates is, and more information can be found in this article.
Tasks of Notified Bodies
As third parties, Notified Bodies are obligated to neutrality and must perform conformity assessments to the best of their knowledge. Examination of conformity assessment is also their primary task. This includes examining the technical documentation and the testing of the individual products and their construction plans. Furthermore, they are responsible for the monitoring and certification of quality management systems. Unannounced audits are also within the scope of the Notified Bodies. However, one should mention that the final responsibility of their products, concerning the MDR and IVDR, lies with the manufacturers.
Requirements for Certificates
Annex XII of the MDR and IVDR sets out the requirements for certificates. These include that each certificate may only be issued to manufacturers for one conformity assessment procedure. Notified Bodies are thus required to demonstrate which product is covered by which certificate and to enter amendments in certificates referring to the previous one. In addition, they must contain the following minimum information:
- Data of the Notified Body
- Data of the manufacturer or the authorized representative
- Unique identification number
- Registration number of the manufacturer
- Date of issue
- Expiration date
- Data for unique identification of the product
- Reference to the regulation according to which the conformity assessment was carried out
- Results of the assessment
Conformity Assessment
Since manufacturers can only place their products on the market if they meet the relevant requirements, conformity assessment is essential. For this purpose, they are tested and examined so that they subsequently receive a certificate. It helps to ensure that only safe products are available in the EU. Because the MDR and IVDR cover a wide range of different products, it is evident that various procedures are carried out for different products. The respective regulation specifies the exact approach to these conformity assessment procedures. Usually, the manufacturers carry out these procedures themselves. For some products, however, it is necessary to involve a notified body and have the conformity evaluated there.
Differences to the MDD
With the entry into force of the MDR and IVDR, not only the manufacturers are faced with a significant task. Notified Bodies are also affected, which in turn impacts manufacturers. Many products that were not yet included under the Medical Device Directive (MDD) and In-Vitro Diagnostic Directive (IVDD) will be under the new regulations. As a result, more devices must be tested, inspected, and certified by Notified Bodies than before. For manufacturers, this means they may have to wait longer for a conformity test for their products than before. In addition, the Notified Bodies also must be re-designated by the EU, which takes time. It can lead to bottlenecks here. As one of the EUDAMED modules, Notified Bodies and Certificates are an important part of the MDR. Good and early preparation is therefore indispensable.
[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: Dezember 2022)