Notified Bodies: Who Certifies You, and the Capacity Problem

A notified body is a private organisation designated by an EU member state to assess whether a device conforms to EU MDR before it can be CE marked.

It is not a regulator. It is a conformity assessment body, designated and monitored by the national authority that appointed it, and paid by the manufacturer it assesses. That arrangement is unusual coming from FDA, where the reviewer is the regulator.

When you need one

By class:

• Class I, not sterile, no measuring function, not reusable surgical: you self-certify. No notified body.
• Class I sterile, measuring, or reusable surgical: a notified body assesses the specific aspect.
• Class IIa, IIb and III: a notified body is required, with the depth of assessment increasing by class.

MDR moved many devices up, particularly software under Rule 11, so a manufacturer that self-certified under the directive may need one now.

What it assesses

The quality management system, usually against ISO 13485, audited on site and re-audited at least annually with unannounced audits in addition.

The technical documentation, sampled or in full depending on class, against the general safety and performance requirements.

For Class III and certain implantables the notified body also consults an EU expert panel on the clinical evaluation.

The output is a certificate with a validity period, and surveillance continues throughout it.

What it cannot do

It cannot advise you into compliance. A notified body assessing your device cannot also consult on how to make it conform, which is the conflict its designation exists to prevent. Manufacturers used to a pre-submission conversation with FDA find this the sharpest difference.

It cannot move faster than its capacity. This is the practical constraint. The number of designated bodies fell substantially in the transition from directive to regulation, and the number of devices needing assessment rose. Queues are measured in months, and a body may decline to take on a new client at all.

Plan the assessment date backwards from your launch, and secure the slot before the file is finished.

Choosing one

• Designation scope. Each body is designated for specific device codes. Confirm yours is covered before anything else.
• Capacity and current queue, honestly asked.
• Experience with your device type, which affects both timeline and the quality of the questions.
• Whether they will take you. A small manufacturer with a novel device is not always attractive to a body with a queue.

NANDO, the European Commission's database, lists designated bodies and their scopes.