Notified Body
What is a Notified Body?
A Notified Body is an independent conformity assessment organisation designated by an EU member state to evaluate whether certain medical devices meet the requirements of applicable EU legislation before they are placed on the market. Under Regulation (EU) 2017/745 (EU MDR) and Regulation (EU) 2017/746 (IVDR), Notified Bodies play a central role in the CE marking process for higher-risk medical devices and in vitro diagnostic devices.
Why It Matters
Not all medical devices can be self-certified by the manufacturer. For higher-risk device classifications, the involvement of a Notified Body is mandatory before a CE mark can be applied and a device placed on the EU market. The Notified Body provides independent scrutiny of the manufacturer’s technical documentation, quality management system, and clinical evidence to ensure the device meets the General Safety and Performance Requirements of the regulation.
Choosing a Notified Body and successfully completing the conformity assessment process is one of the most significant steps in bringing a regulated medical device to the EU market. Delays or failures at this stage can prevent or significantly delay market access.
For medical device manufacturers, understanding the role of Notified Bodies and the conformity assessment process is essential for planning a compliant route to the EU market.
Key Requirements
When Is a Notified Body Required?
Involvement of a Notified Body is required for:
- Class IIa, Class IIb, and Class III medical devices under the EU MDR
- Higher-risk IVD device classifications under the IVDR
This requirement applies under:
- Regulation (EU) 2017/745 – Medical Device Regulation (EU MDR)
- Regulation (EU) 2017/746 – In Vitro Diagnostic Regulation (IVDR)
Class I medical devices that are non-sterile and have no measuring function may be self-certified by the manufacturer without Notified Body involvement, though exceptions apply for certain Class I devices with specific characteristics.
Responsibilities of a Notified Body
While specific activities depend on the device classification and conformity assessment route, a Notified Body’s responsibilities commonly include:
- Reviewing the manufacturer’s technical documentation and clinical evaluation reports
- Auditing the manufacturer’s quality management system
- Issuing EU MDR or IVDR certificates where conformity requirements are met
- Conducting surveillance audits to verify ongoing compliance
- Suspending, restricting, or withdrawing certificates where compliance can no longer be confirmed
- Registering issued certificates in EUDAMED
Notified Body vs. Approved Body (UK)
These are equivalent but separate roles under different regulatory frameworks. A Notified Body operates under EU legislation and is designated by an EU member state to assess conformity for the EU market. An Approved Body is the UK equivalent, designated by the MHRA to carry out conformity assessments for the Great Britain market under UK regulations.
Manufacturers placing devices on both the EU and UK markets will generally need to work with both a Notified Body and an Approved Body, as assessments carried out under one framework are not automatically recognised by the other.
Need Medical & IVD Device Compliance support for the EU and UK?
Euverify provides end-to-end EU MDR and UK regulatory compliance for medical device and IVD manufacturers — including EU Authorised Representative, EUDAMED, HPRA, and MHRA registration. Our team supports technical documentation review, regulatory communication, and ongoing compliance management across both markets.
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