Do I need a Notified Body?

Whether a Notified Body is involved follows from the class, which is why the class has to be settled first. If you do not have one yet, the questionnaire takes about five minutes.

“Class I, so no Notified Body” is right most of the time and expensive when it is wrong. Three sub-categories pull one back in:

• —Class Is — the device is supplied sterile. The Notified Body assesses the establishment, securing and maintenance of sterile conditions.
• —Class Im — the device has a measuring function. The assessment covers the metrological requirements, not the clinical performance.
• —Class Ir — the device is a reusable surgical instrument. The assessment covers reuse: cleaning, disinfection, sterilisation, maintenance and functional testing, and the related instructions.

A sterile, reusable instrument with a measuring function is Is, Im and Ir at once. The Notified Body's scope is the union of those aspects — still not the whole device, but no longer a narrow review either.

This is the most consequential misunderstanding in the whole area. Not needing a Notified Body removes an auditor, not the obligations. For an ordinary Class I device you must still:

• —compile and maintain the technical documentation in Annexes II and III, including the classification rationale;
• —carry out and keep current a clinical evaluation;
• —operate a quality management system proportionate to the device;
• —appoint a person responsible for regulatory compliance under Article 15 — micro and small enterprises may use a permanently available external person rather than an employee;
• —assign a UDI and register the device and the economic operators in Eudamed;
• —run post-market surveillance under Article 84 and produce a PMS report;
• —draw up the EU declaration of conformity and affix the CE marking.

Notified Bodies are designated for specific ranges of device types, and may only assess devices inside their designation. The public database of designated bodies lists each one's scope. Check it before making contact: approaching a body that cannot lawfully assess your device is a common way to lose several weeks.

There are far fewer designated bodies under the Regulation than there were under the directives, and demand has outstripped them. Waiting lists are a normal part of planning rather than an exception, and a body may decline a client whose portfolio does not fit its priorities.

The practical consequence for a project plan: contact bodies early, expect the conversation to start with a scoping questionnaire rather than a quotation, and treat the contract date rather than the application date as the start of the timeline.

• —Implantable Class IIb — technical documentation is assessed for every device, except for the items listed in Article 52(4) such as sutures, staples, dental fillings, screws, wedges, plates, wires, pins, clips and connectors.
• —Class III implantable — the clinical evaluation consultation procedure applies, in which an independent expert panel may review the Notified Body's assessment. It adds materially to the timeline and cannot be compressed.
• —Devices with a medicinal substance — the Notified Body must consult a medicines authority on the substance. Two regulators, two timelines.

The instinct on discovering that a device is IIa rather than I is to look for a way back down. There is a legitimate one and an illegitimate one, and they look similar from the inside.

Legitimate: the intended purpose was drafted more broadly than the product warrants. Narrowing it to what the device actually does — and removing the claims that were aspirational — can change the class, because the class follows the intended purpose. This is a real exercise and it is done in the technical documentation, not in the marketing.

Illegitimate: writing an intended purpose that contradicts how the device is sold. A Notified Body reads the website alongside the file, and an authority reads both after an incident.

Every class except Class I. Class IIa, IIb and III all require a Notified Body. Class I devices are self-declared, unless they are supplied sterile, have a measuring function, or are reusable surgical instruments — in which case a Notified Body assesses that specific aspect only.

Yes. For an ordinary Class I device the manufacturer compiles the technical documentation, performs the clinical evaluation, draws up the EU declaration of conformity and affixes the CE marking without any Notified Body. That is self-declaration, not self-regulation: every other obligation still applies.

Sub-categories of Class I: Is for devices supplied sterile, Im for devices with a measuring function, and Ir for reusable surgical instruments. Each requires a Notified Body, but only for the aspect concerned — sterility, metrological performance, or reprocessing — not for the whole device.

No. The manufacturer classifies the device and documents the rationale; the Notified Body reviews that rationale as part of conformity assessment and can challenge it. Discovering at that point that the class was wrong is the expensive way to find out.

No. Notified Bodies are designated for specific ranges of device types, and can only assess devices within their designation. Approaching one that is not designated for your device type wastes weeks, so check the scope before making contact.