Notified Body

Whether you need to engage a Notified Body (NoBo) depends on the Directive or Regulation applicable to your product. A rule of thumb is that if it's a high-risk product such as a medical device or, for example, a product for use in potentially explosive atmospheres, the likelihood increases. Also, for pressure equipment, especially with gas, and particularly if it's a hazardous gas, you'll likely need one. We provide some explanation in a short video. And, if you scroll down further, we offer more explanation for several Directives/Regulations.

 

A NoBo is a conformity assessment body notified to the European Commission. An overview of NoBos can be found in the NANDO database of the European Commission. Whether you are obliged to engage a NoBo depends on the risks of the product. For a hazardous product, it is highly likely that engaging a NoBo is mandatory. For instance, the Machinery Regulation includes a list of 'dangerous machinery,' consisting of Part A and Part B. If the product is in Part A, a NoBo must be engaged; if it's in Part B, it may be engaged but is not mandatory.

For the EMC Directive, Low Voltage Directive, and also the RED Directive, a NoBo does not always need to be engaged, provided that the supporting evidence (=tests) have been carried out based on certain (harmonized) standards. You can often perform these tests yourself or outsource them to a testing laboratory (not a NoBo).

In short, engaging a NoBo is mandatory for high-risk products such as medical devices, products for use in potentially explosive atmospheres, and certain dangerous machinery. But only from a certain category.

That may be so, but how do I find out if I need to engage a NoBo?

  1. Determine the Directives applicable to your product.
  2. Look in those Directive(s) for something like: 'Conformity Assessment'.
  3. Check if you find any indications there that you can do it yourself or not.
  4. If engaging a NoBo is not mandatory, you can do it yourself, and you can find supporting documents and e-learnings on our site.
  5. If you do need to engage a NoBo, you can find them in the NANDO Database of the European Commission.

We summarize the conditions for engaging a NoBo per Directive. We don't have them in Dutch yet, but I think the explanation is clear.

Machinery Regulation (valid from 2027)

So if your product is in Part A, you must call a NoBo. Below you can see which products fall under Part A. As you might expect, there is also a 'Part B', these are also higher-risk products, but for the products mentioned there, the manufacturer may assess conformity themselves.

PART A - Machinery RegulationCategories of machinery and related products for which a procedure as referred to in Article 25, paragraph 2, must be followed
  1. Removable mechanical transmission systems, including their guards.
  2. Guards for removable mechanical transmission systems.
  3. Vehicle lifting equipment.
  4. Portable cartridge-operated fastening tools and other impact machines.
  5. Safety components with fully or partially self-evolving behavior using machine learning methods that ensure safety functions.
  6. Machinery with integrated systems, not independently placed on the market, with fully or partially self-evolving behavior using machine learning methods that ensure safety functions, solely with regard to those systems.

Current Machinery Directive

In the current Machinery Directive, the obligation to engage a NoBo is shown in the diagram below.

EMC Directive

For electronics that are self-designed or being designed, an EMC test may be necessary to demonstrate conformity with this Directive, as there would be no paper evidence otherwise. However, such tests do not need to be performed by a Notified Body but can also be conducted in-house, provided that harmonized standards are used for the tests.

When performing EMC tests, ensure that a report is produced which can later demonstrate that the immunity and emission requirements of the EMC Directive, whose limit values are specified in certain standards associated with the EMC Directive, have been met.

Low Voltage Directive

For the Low Voltage Directive, similar principles apply as for the EMC Directive. Here too, you must have evidence of compliance, and if it involves purchased components, check the documentation. If it's your own design, you often lack this burden of proof, so a test will need to be performed. Use harmonized standards falling under the Low Voltage Directive for this. You can perform these tests yourself or outsource them.

ATEX 114 Directive

If your product is intended for use in potentially explosive atmospheres, it will fall under ATEX 114. If it is a mechanical product (i.e., not electrical) and suitable for Zone 0, you must engage a NoBo. The same applies if it is an electrical product suitable for Zone 0 and/or Zone 1.

And, if that is not the case, you do not need to engage a Notified Body. Of course, you may, but it is not mandatory based on the Directive.

If you need to engage a Notified Body, request multiple quotes and also check which tests are included in the quote, as we often see that more tests are 'quoted' than necessary.

 

Author: Drs. Richard Winter

If you have any questions about this, please contact us.