Everything you need to know about Notified Bodies and CE marking in the EU

For companies that import from Asia and want to introduce their products in the European Union, Notified Bodies are indispensable. These independent EU-designated bodies assess whether products comply with strict EU guidelines and regulations, an important step in obtaining the CE mark. 

This marking, necessary for product categories such as medical devices, electronics, personal protective equipment, lighting, and toys, confirms that a product meets all relevant European safety and quality requirements. Involving a Notified Body (NB) is therefore unavoidable for importers when their products are subject to EU regulations that require an independent assessment. After all, without the CE mark it is not permitted to place the product on the EU market.

The role of Notified Bodies in the EU market

Notified Bodies are crucial for maintaining high safety standards within the European market. By providing objective assessments of a wide range of products, from medical devices to toys and electronics, they ensure they meet EU standards. Their in-depth analysis supports manufacturers in identifying and correcting any non-conformities before products enter the market, protecting the health and safety of EU citizens. Given the complexity of EU regulations, it is essential that Notified Bodies have extensive expertise and are thorough in their review processes.

Read more:

Everything you need to know about CE marking

In this blog we explain what a CE marking is and for which products it is required. 

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The certification process: what should you take into account?

The certification process requires manufacturers to prepare extensive documentation and subject it to technical reviews and product testing. This ensures that products are not only safe but also meet EU sustainability and environmental standards. Successful certification opens up new markets for manufacturers and gives them a competitive advantage, despite the initial efforts and costs involved.

The choice of a suitable Notified Body

A strategic approach is required when selecting a Notified Body, taking into consideration the body's specialization, experience and ability to provide thorough assessments. Good cooperation can significantly facilitate the certification process, allowing products to be brought to market faster. It is very important to choose a Notified Body that is not only accredited within the relevant sector, but also has an in-depth understanding of the specific challenges and requirements of the products.

A list of Notified Bodies:

Personal protective equipment (PPE)

The list below is for personal protective equipment (PPE), Regulation (EU) 2016/425.

Notified body	Number	Country
	2797	Netherlands
	2777	Ireland
	0075	France
	0493	Belgium
	2849	Netherlands

This is just a selection of the many Notified Bodies that exist in the EU. Check the European Commission website for an up-to-date list.

Medical

The list below is for medical devices, Regulation (EU) 2017/745.

Notified body	Number	Country
	2797	Netherlands
	0044	Germany
	1639	Belgium
	0344	Netherlands
	1912	Netherlands

This is just a selection of the many Notified Bodies that exist in the EU. Check the European Commission website for an up-to-date list.

Toys

The list below is for toys, Directive 2009/48/EC.

Notified body	Number	Country
	0364	France
	0364	Italy
	0439	Belgium
	0158	Germany
	2817	France

This is just a selection of the many Notified Bodies that exist in the EU. Check the European Commission website for an up-to-date list.

Building materials & building products

The list below is for building materials, Regulation (EU) 205/2011.

Notified body	Number	Country
	1117	Netherlands
	2821	Netherlands
	1639	Belgium
	0026	Belgium
	0197	Germany

This is just a selection of the many Notified Bodies that exist in the EU. Check the European Commission website for an up-to-date list.

Electronics and lighting

The list below is for Electromagnetic Compatibility (EMC), Directive 2014/30.

Notified body	Number	Country
	0681	Germany
	0063	Netherlands
	0649	Belgium
	0123	Germany
	0344	Netherlands

This is just a selection of the many Notified Bodies that exist in the EU. Check the European Commission website for an up-to-date list.

Conclusion 

Notified Bodies play an indispensable role in the European Union's regulatory landscape, ensuring that products imported from Asia meet the highest safety and quality standards. Their assessments are fundamental to obtaining the CE marking, a crucial step for importers to gain access to the EU market. By navigating the complex certification process, Notified Bodies not only provide a path to compliance but also help strengthen consumer confidence in imported products. Their expertise and services are indispensable for maintaining the integrity and security of the European market, and for supporting manufacturers in successfully introducing their products into the EU.