CE Marking and Notified Bodies: What They Are, When You Need One, and How to Manage the Process
When a manufacturer starts looking into CE marking for the first time, the question of Notified Bodies comes up quickly. Do I need one? How do I find one? How much does it cost? The short answer to the first question is: probably not. When a Notified Body is required, though, the process involves a set of friction points that most manufacturers do not anticipate and that can derail an otherwise well-planned compliance project. This post covers what you need to know before making any decisions.
What is a Notified Body?
A Notified Body is an organisation designated by an EU member state to carry out conformity assessment procedures on behalf of the European Commission.
Their role is to independently evaluate whether certain products meet the essential requirements of the EU directives that apply to them, in cases where manufacturer self-declaration is not sufficient.
Every Notified Body has a unique identification number and is listed in NANDO, the New Approach Notified and Designated Organisations database maintained by the European Commission. NANDO is the authoritative public registry: it shows which organisations are designated, for which directives, and for which specific conformity assessment modules. Before engaging any Notified Body, checking their NANDO listing is the only way to confirm they are actually authorised to certify your product.
A Notified Body’s designation is specific. An organisation notified for the Machinery Regulation may not be notified for the Radio Equipment Directive. An organisation notified for module B may not cover module H. Assuming that any accredited body will do is one of the most common and costly mistakes in this process.
When you DO NOT NEED a Notified Body
The majority of products that require CE marking can achieve conformity through self-declaration. The manufacturer carries out the conformity assessment internally, prepares the technical file, signs the Declaration of Conformity, and affixes the CE marking. No third-party involvement is required.
Self-declaration is possible when the applicable directive permits conformity assessment under Module A, the most basic module, which places the full responsibility for assessment on the manufacturer. Module A is available for a wide range of product categories, including most machinery under the new Machinery Regulation (EU) 2023/1230, most products under the Low Voltage Directive, radio equipment under the RED where harmonised standards are applied, and products under the General Product Safety Regulation.
A Notified Body only enters the picture when the applicable directive requires a conformity assessment module that involves third-party intervention: Modules B, C, D, E, F, G, or H. These apply to products where the level of risk justifies independent verification, including PPE category III, certain pressure equipment under the PED, and gas appliances. If your product falls into one of these categories, the directive itself will say so: the annexes describing the conformity assessment procedures specify which modules are available and whether a Notified Body is required.
If you are not certain which module applies to your product, we can clarify this before you take any further steps.
When you SHOULD NOT contact a Notified Body yet
Manufacturers sometimes conclude too quickly that a Notified Body is needed and reach out before the preparatory work is done.
If the applicable directives have not been correctly identified beforehand, the manufacturer may contact a NoBo that is not authorised for their specific product, request the wrong conformity assessment module, or receive a quote for a scope that does not match what is actually required. Any tests commissioned on that basis may produce results that are not valid for the final certification, at a cost that is not recoverable.
The underlying issue is structural: Notified Bodies are not authorised to provide consultancy services. They cannot tell you which directives apply to your product, what is wrong with your technical documentation, or how to prepare your file to pass their review. Their function is to evaluate what you present to them. Arriving without a correctly scoped and properly prepared file produces avoidable revision cycles and timelines that extend without a clear endpoint.
The first friction point: requesting a quote
Once it is established that a Notified Body is genuinely required, the first practical challenge is getting a quote. Most NoBos use dense, technically detailed application forms that require precise information about the product, the applicable directives, the specific modules being requested, the harmonised standards being applied, and the scope of the assessment. Completing these forms accurately is not trivial, particularly for manufacturers with limited prior experience of the EU conformity assessment system.
Going it alone here carries two risks. An incomplete or incorrectly scoped application slows the process before it has even started. And completing a single application form takes significant time and energy: many manufacturers end up submitting to one NoBo only, with no basis for cost comparison and no leverage in the process.
A consultant with existing relationships across multiple Notified Bodies can anticipate certification costs from an early stage of the project, manage parallel quote requests efficiently,
and present the application in a format that NoBos recognise and process without unnecessary back-and-forth. The time saving is real, and the cost visibility it provides from the outset changes the project planning entirely.
The geography question
NoBos based in Eastern Europe tend to offer significantly more competitive pricing than their counterparts in Western Europe.
The decision is worth making consciously rather than purely on cost. It is a well-known pattern in the industry that many Chinese manufacturers have a strong preference for Eastern European Notified Bodies. The question worth asking is what signal the choice of certifying body sends in the specific markets where the product will be sold. For some buyers in some sectors, the name on the certificate carries weight. For others, it is entirely irrelevant. There is no universal answer. The decision should be made with that question on the table, not after the certificate has been issued.
The most tedious friction: managing the project
The friction that manufacturers find hardest to anticipate is the ongoing communication dynamic once the process is underway.
A Notified Body operates differently from a consultant. It will not proactively flag potential issues before they become formal objections, or give you visibility on where your application stands in the queue.
Communication is formal and structured, response times vary, and the assessment timeline is rarely communicated with the transparency that a project manager would expect.
A consultant who acts as an intermediary adds value that is difficult to quantify until you have experienced the alternative. Someone who knows how to prepare documentation in a format that minimises revision cycles, who understands the working patterns of specific NoBos, and who can manage the follow-up without the manufacturer having direct exposure to the formality of the process makes a material difference to how long the certification takes and how much it costs in management time.
Obtaining a certificate from a Notified Body does not automatically demonstrate compliance with ALL applicable EU directives. A NoBo certification covers the scope for which it was issued, nothing more. A Machinery Regulation certificate addresses the essential health and safety requirements under that regulation. If the machine incorporates electronic components, the RoHS Directive applies independently and requires a separate assessment. A Pressure Equipment Directive certificate says nothing about ATEX compliance if the equipment is intended for use in potentially explosive atmospheres. Each directive is a separate obligation, and the CE marking on the product represents the manufacturer’s declaration of conformity with all of them, not just the ones where a NoBo was involved.
Almost no one raises a second point during the initial project planning: what happens when the product changes after certification.
A Notified Body’s certificate covers the product as it was assessed. A component substitution, a firmware update, or a change of supplier for a safety-critical part may require a new assessment, a formal change notification, or at minimum a review of whether the existing certificate remains valid. Many manufacturers discover this when a change is already in production and the compliance status of the product is suddenly unclear.
Managing the post-certification lifecycle of a CE-marked product requires the same structured attention as the original certification. A consultant who stays involved across the product’s life, not just through the initial project, is the most reliable way to avoid the kind of late-stage surprises that these changes can generate.
Where to start
The Notified Body question is one part of the CE marking process, not the starting point. The decisions that determine whether you need one, which one is appropriate, and how to manage the engagement efficiently all depend on preparatory work that comes before any NoBo is contacted.
If you are at the stage of understanding whether a Notified Body is relevant to your project, contact us to start that conversation.
