Unlocking the Mysteries of CE Certification: What You Need to Know

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So we’ve been referring to CE certification a lot in this course so far.

In this lesson, let’s jump into exactly what it entails.

‘CE’ here stands for Conformité Européenne", which means European conformity, and many products require this marking before it can be sold in Europe.

A CE certificate or a CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.

It tells the authorities that it meets all the directives and the subdirectives, like the RoHS or EMC directives.

Although you do not need a license to affix the CE marking to your product, you MUST ensure conformity with all relevant EU-wide requirements.

So basically, these directives provide technical standards and guidelines on how the product should be manufactured or packaged.

These help ensure that your product doesn’t reach the market in bad shape which could harm consumers in any way.

The CE marking also gives you an indication on how the product should be labelled.

As we’ve learned, the EC-DoC isn't necessarily evidence or PROOF of conformity unless a sample is taken to an accredited third party laboratory for testing.

If the CE requirements are met, then you can go ahead and fix the CE mark onto your product packaging.

Note that if the CE marking cannot be placed on the product itself then it can be affixed to the packaging or on any accompanying documents.

So, if the CE mark is a self-assessment, then when would you be required to involve a notified body?

And more importantly, WHAT is a notified body?

Well, a notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.

They carry out the necessary conformity assessments set out by the applicable legislation.

Whether or not you need to involve a notified body depends on the type of product you’re trying to get on to the market.

Products have varying requirements in the EU.

Let’s say we have a product which falls under the Medical Devices Directive, also known as the MDD.

If it’s a class 1 or “low risk” device, it need not involve a notified body, unless the product has a measuring function or is placed on the market in a sterile condition.

On the other hand, for all medical devices which belong to class 2a, 2b or class 3 the device DOES require the involvement of a Notified Body.

So it's important to consider your product to see what sector it falls under and whether it requires a Notified Body for the conformity assessment.

In cases where you do need to involve a Notified Body, the particular Notified Body issues a certificate upon successful completion of the assessment which indicates that it has been verified and what has been verified.

A four digit code is placed behind the CE logo which refers to the notified body that made the assessment.

Each notified body has their own number and these can be found on the European Commission website in their NANDO database, which is also known as the New Approach Notified and Designated Organisations database.

Now, another important point to address is that, not ALL products can have the CE marking and it’s actually forbidden to put the marking on products which do not have EU specifications or do not require the affixing of the CE marking.

Products which fall under the section called “exceptions” in a given directive are not allowed to have a CE marking affixed.

So, let's recap.

Affixing the CE marking is a declaration by the manufacturer that their product conforms to the relevant EU regulations.
The CE mark is essentially a self-declaration but in some cases might require the involvement of a Notified Body.
It enables free movement in the EU member states according to Article 28. Some non- EU countries have also adopted the CE marking procedures.
Whichever party declares the product as CE compliant carries the responsibility of ensuring it meets the requirements.
This mark is not a quality guarantee. Your product still has the potential to be non-compliant if you haven’t been through the testing process or if you haven’t involved a Notified Body.
Not all products may have the CE marking affixed. Your product may require the CE mark if it does NOT fall in the “exceptions” category under the applicable directive.

Just to reiterate, in the cases where you are not obligated to use a Notified Body, you will have to evaluate your product and determine whether it is worth it for you to go through all the testing or if it might be better just to self-declare.