EU Notified Body Search and Selection for Medical Devices and IVDs

What is an EU Notified Body?

A Notified Body is an independent conformity assessment organization designated by an EU Member State authority for a defined legal and technical scope. It is not an EU regulator and it does not issue government product approvals. The European Commission explains the role on its official medical device Notified Bodies page.

Under the MDR or IVDR, a Notified Body can audit a manufacturer’s quality management system, assess technical documentation and issue certificates for the conformity assessment procedures within its designation. The manufacturer still owns device compliance, the EU Declaration of Conformity and post-market responsibilities.

When does a medical device manufacturer need a Notified Body?

The need depends on the regulation, device classification and device characteristics. Most devices above Class I under the MDR require Notified Body involvement. Certain Class I sterile, measuring or reusable surgical instruments require limited involvement, while many other Class I devices can use self-declaration. Under the IVDR, most devices beyond Class A non-sterile require a Notified Body.

Classification should be confirmed before approaching a body. See the medical device classification glossary and Pure Global’s EU MDR classification guide.

How can a manufacturer verify a Notified Body's scope?

A four-digit identification number alone does not prove that a body can assess every device. Manufacturers should use the official NANDO database to verify the applicable legislation, conformity assessment procedures and device codes within the body’s designation.

The technical scope must cover the actual device and technology. Manufacturers should also evaluate capacity, experience, audit model, certificate transfer constraints, language, locations, timelines and contractual terms. Only one formal application for the same conformity assessment activity may be active with one Notified Body at a time.

What does a Notified Body review?

The review can include the quality management system, device technical documentation, risk management, clinical or performance evidence, software, sterilization, labeling and post-market arrangements. The exact depth depends on the conformity assessment route and risk class.

If the assessment is successful, the body issues the relevant certificate. The manufacturer then completes its EU Declaration of Conformity and affixes the CE marking, with the Notified Body number where required.

How should a manufacturer select a Notified Body?

Start with designation and device fit, then compare availability, reviewers’ technical competence, audit approach, communication, expected evidence, fees and realistic scheduling. A short list should be evidence-based; brand recognition alone is not enough.

Pure Global supports Notified Body search and selection, EU MDR and EU IVDR planning without treating Notified Body certification as the same thing as regulatory approval.