Understanding Notified Bodies and Their Role in Compliance with EU Regulation 2016/425 for Personal Protective Equipment (PPE)

What are Notified Bodies?

Notified bodies play a critical role in maintaining safety standards across the European Union (EU), especially when it comes to Personal Protective Equipment (PPE). They are independent organizations designated by EU member states to conduct conformity assessments, ensuring that products meet the stringent requirements of EU regulations. Under EU Regulation 2016/425, which governs PPE, notified bodies assess products such as gloves, masks, helmets, goggles, and other protective gear, confirming that they adhere to the essential health and safety requirements.

Notified bodies are responsible for evaluating both the design and manufacturing processes of PPE. For high-risk equipment (Category III), they conduct ongoing quality assurance and surveillance to ensure continuous compliance. Once PPE passes these assessments, manufacturers receive a CE marking for their products, allowing them to be sold across the European Economic Area (EEA).

Importance of Compliance with EU 2016/425

The EU 2016/425 regulation is designed to protect users from various hazards in the workplace and in other high-risk environments. Compliance with these requirements is essential not only for market access but also to ensure user safety. Notified bodies help enforce these standards, creating an additional layer of confidence for consumers and professionals relying on PPE for their safety.

List of Notified Bodies for EU Regulation 2016/425

Here is a (non-exhaustive) list of some prominent notified bodies designated to assess PPE under EU 2016/425:

1. CCQS Certification Services Limited (NB2834) – Ireland

2. A.N.C.I. SERVIZI S.R.L (NB465) – Italy

3. ALIENOR CERTIFICATION (NB2754) – France

4. TÜV Rheinland (NB197) – Germany

5. Satra Technology Europe Ltd (NB2777) – Ireland

   
   

These organizations are authorized to assess PPE products and certify compliance with EU 2016/425. Manufacturers and suppliers can work with notified bodies to ensure their PPE meets the necessary standards, enabling them to place their products on the European market safely and legally.

To see the full list of notified bodies designated for EU Regulation 2016/425, you can visit the European Commission’s NANDO (New Approach Notified and Designated Organisations) database:

Full List of Notified Bodies for EU 2016/425 on NANDO

This database is updated regularly and provides complete details of all notified bodies across different regulations, including their areas of expertise and contact information.