{"id":6943,"date":"2026-04-01T11:16:35","date_gmt":"2026-04-01T09:16:35","guid":{"rendered":"https:\/\/mediconomics.com\/?post_type=glossary&p=6943"},"modified":"2026-07-13T19:09:18","modified_gmt":"2026-07-13T17:09:18","slug":"notified-body","status":"publish","type":"glossary","link":"https:\/\/mediconomics.com\/en\/glossar\/notified-body\/","title":{"rendered":"Notified Body"},"content":{"rendered":"

A Notified Body is an organisation designated by an EU Member State and notified by the EU to carry out conformity assessments for certain product groups. In the context of medical devices and in vitro diagnostics, the Notified Body checks whether manufacturers meet the requirements of the relevant EU regulations. The outcome is, for example, certificates that may be a prerequisite for CE marking and placing on the market in the EU.<\/p>\n

Tasks of the Notified Body in the MDR and IVDR context<\/h2>\n

For manufacturers running medicinal product and medical device projects in parallel, the role logic of the Notified Body is often unfamiliar: unlike regulatory authorities, the Notified Body is contractually engaged but nevertheless acts independently and follows its own internal review processes. This means that project plans should take into account not only regulatory deadlines but also the capacity windows and review cycles of the Notified Body. An early-aligned submission package and a consistent line of argument across all documents considerably reduce queries.<\/p>\n

Under the EU Medical Device Regulation (EU) 2017\/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017\/746 (IVDR), Notified Bodies are central gatekeepers. Among other things, they assess the quality management system, the technical documentation, the clinical evaluation and post-market obligations. Depending on the risk class and conformity assessment procedure, they carry out document reviews, audits and, where necessary, additional assessments. For manufacturers, the Notified Body is therefore a critical project factor with an influence on timelines, evidence requirements and change management.<\/p>\n

Distinction: Notified Body vs. authority<\/h2>\n

Notified Bodies are not authorities but independent assessment organisations that carry out conformity assessments on behalf of the manufacturer. Authorities (e.g. national competent authorities), by contrast, oversee the market, intervene in the event of safety issues, and can order inspections or measures. In practice, information flows overlap: findings from vigilance and market surveillance can affect certificates, and conversely, Notified Bodies can report certain findings to authorities, insofar as this is provided for within the regulatory framework.<\/p>\n

Conformity assessment: process and submission package<\/h2>\n

The process often begins with the selection and engagement of a suitable Notified Body. This is followed by submission of the technical documentation, including the clinical evaluation (e.g. Clinical Evaluation Report) and risk management. In parallel or subsequently, Notified Bodies audit the manufacturer’s quality management system. Findings are documented in the form of nonconformities, which the manufacturer must address within set deadlines. Upon successful completion, a certificate is issued, which is regularly monitored and can become relevant in the event of significant changes to the product or system.<\/p>\n

In implementation, “submission management” is a success factor in its own right: clear versioning, consistent terminology and a traceable chain of argument across intended purpose, classification, clinical claims and risk controls. If this line breaks (e.g. a claim in marketing materials without evidence in the CER), queries and follow-up requests almost always arise.<\/p>\n