Is a notified body mandatory?

What a notified body is

A notified body is an independent organization authorized to perform conformity assessments for specific European legislation. The Member State notifies such a body via a notifying authority. The European Commission then assigns a single identification number and publishes the list of all notified bodies.

That distinction matters. The body is not designated by Brussels but notified by a Member State. The Commission manages the register. Each body receives only one number, even if it is notified for multiple acts.

Also, note the terminology. Assessing it yourself is called self-declaration, not self-certification. Certificates come from a body; declarations come from you. That difference determines who is liable for what.

When you need one

The applicable legislation prescribes which assessment modules are permitted per product category. If internal production control is listed, you can declare conformity yourself. If the act prescribes a type examination or full quality assurance for your category, a notified body is required.

Broadly speaking, these are higher-risk products: certain medical devices, pressure equipment, lifts, explosion-proof equipment, some personal protective equipment, and specific categories of machinery. The act itself lists these categories in an annex.

This is not the case for a large proportion of consumer electronics. Internal production control is sufficient there, provided you have covered the requirements demonstrably and according to the prescribed procedure.

When self-declaration shifts

There is a second route to a mandatory body. This is not found in the product category but in your own choices. If you do not apply the harmonized standards, or only apply them partially, the legislation prescribes a more rigorous procedure for certain products than you might have expected.

The Radio Equipment Directive is the clearest example of this. If you have applied the standards whose references are in the Official Journal, you may use internal production control. If those standards are not applied or only partially applied, your product must undergo an EU-type examination or full quality assurance. The same applies when such standards do not exist.

A design choice can therefore change your route. This is exactly why the choice of standards belongs early in the process and not afterward, when the product is already in production.

A number on its own says nothing

A body is notified for specific acts, modules, and products. If there is a number behind the marking, check whether that body is notified for exactly the act that applies to your product. The Commission publishes that scope per body.

Why you must check the scope

The Commission publishes the identification number and the activities for which each notified body is notified. This list is public and can be consulted free of charge. You can therefore verify for yourself whether a body is authorized for your act, your module, and your specific product type.

This is not a theoretical check. We encounter certificates from laboratories that deliver excellent work but are not notified for the relevant act. The report is then useful as supporting evidence, but it does not replace the required assessment.

Not sure if you need a notified body?

Briefly let us know what kind of product it concerns. We will contact you regarding which route applies.

What to look for when choosing

Price is rarely the determining factor. More important are the scope, the lead time, experience with your product type, and whether the body can also handle the subsequent steps. Therefore, ask in advance about the waiting time and exactly what is included in the quote.

Scope. Is the body notified for your act, your module, and your product type?
Lead time. Ask for the current waiting time, not the average. This varies greatly per period.
Experience. A body that has seen your product type more often will ask sharper questions and deliver faster.
Follow-up. Can the same body also handle the changes and follow-up certificates?
What is included in the quote. Assessment, tests, extra rounds for findings, and annual obligations are often separate line items.

The impact on time and costs

A notified body is usually the largest cost item in a CE process and simultaneously the greatest uncertainty in your launch planning. The assessment itself takes weeks to months. Furthermore, findings lead to an extra round that you rarely plan for in advance.

The practical lesson is: start with the scope question before you produce. If it turns out halfway through that a body is needed, your launch will be delayed by that body’s waiting time, not by the time you need yourself.

What to find out now

In the act applicable to your product, look up the annex with the assessment modules. See which modules are permitted for your category. Then check whether you are fully applying the harmonized standards, as that can still make the route more demanding.

First, determine which act applies. Without that step, you cannot answer the module question.
Find the annex with the conformity assessment procedures and note which modules are available.
Verify whether you are fully applying the harmonized standards. If not, note which parts deviate.
If a body is required, check the public register to see if the chosen body is notified for your act.
Request the current lead time and schedule it before you start production.