Glossary · EU medical devices: MDR
Notified body (MDR and IVDR)
Also known as: Notified body, NB, Conformity assessment body (MDR and IVDR)
Under the EU Medical Device Regulation (EU) 2017/745 and IVD Regulation (EU) 2017/746, a notified body is a conformity assessment body designated by a member state authority under the regulation to carry out third-party conformity assessment of devices. Notified bodies are identified by a four-digit number and listed in the European Commission’s NANDO database.
- EU
- MDR
- IVDR
In one sentence
A notified body is a conformity assessment body designated under MDR or IVDR to audit quality systems and assess device technical documentation.
Example
A manufacturer of class IIb orthopedic screws checks in NANDO that its chosen notified body is designated under the MDR for the relevant device codes, signs a written agreement, and prepares for the QMS audit and technical documentation review under Annex IX.
Explained in context
Context cards connect this term with others to answer one question. Also in British English and German.
- CRA product categories: default, important and criticalWhich CRA products need a notified body, and how many products fall into the stricter categories?UKDeutsch
- Module H under the CRA: BSI TR-03183-H builds full quality assurance on ISO/IEC 27001How can a manufacturer demonstrate CRA conformity through its processes rather than product by product, and what does BSI TR-03183-H add?UKDeutsch
How it applies
- Designation: A notified body must be designated under the MDR or the IVDR specifically, and only for the device types and assessment procedures in its scope. A designation under the former directives does not carry over.
- When needed: Required for all classes above MDR class I and IVDR class A; for class I devices only for the sterile, measuring and reusable-surgical aspects, and for sterile class A IVDs only for the sterility aspects. See conformity assessment.
- What it does: Audits the quality management system, assesses technical documentation on a sampling basis or per device depending on class, issues certificates, performs surveillance audits and unannounced audits, and reviews significant changes.
- Capacity: Limited notified body capacity was a main reason for the extended transition periods, which tie legacy device status to an application and a written agreement with a notified body.
- AI: For AI-based devices that are high-risk under the AI Act, the MDR or IVDR notified body also assesses the AI Act requirements within its procedure, if its designation covers them; see AI in medical devices.
- Technical documentation: Keep the notified body’s number with the CE marking on the label, and keep certificates, audit reports and nonconformity closures as controlled records.
Notified body vs. competent authority
A notified body is usually a private organization acting under designation; it assesses and certifies devices. A competent authority is the national government body that designates and monitors notified bodies, handles vigilance and runs market surveillance. A manufacturer contracts with a notified body but is supervised by the competent authority.