Introduction
A Notified Body (NB) is an independent, accredited organization designated by an EU member state to assess whether a product meets the essential health, safety, and environmental requirements under applicable EU directives and regulations. Notified Bodies play a critical role in third-party conformity assessments for certain products that require additional testing and certification beyond self-declaration.
If your product requires third-party assessment, a Notified Body must be involved in the conformity assessment process before obtaining CE marking.
What Does a Notified Body Do?
A Notified Body performs various conformity assessment tasks, including:
Product testing and certification to ensure compliance with harmonized standards.
Reviewing technical documentation to verify adherence to EU safety requirements.
Conducting factory inspections and audits to confirm quality control measures.
Issuing an EU Type-Examination Certificate, if required.
Monitoring ongoing compliance through periodic assessments.
When Do You Need a Notified Body?
You must engage a Notified Body when: ✅ Your product falls under a directive or regulation requiring third-party assessment. ✅ The product is classified as high-risk and self-certification is not allowed. ✅ The applicable conformity assessment procedure requires a Notified Body review.
Examples of Products Requiring a Notified Body
Product Category | Applicable Directive/Regulation |
Medical Devices | Medical Devices Regulation (MDR 2017/745) |
Personal Protective Equipment (PPE) | PPE Regulation (EU 2016/425) |
Pressure Equipment | Pressure Equipment Directive (PED 2014/68/EU) |
Radio Equipment | Radio Equipment Directive (RED 2014/53/EU) |
Gas Appliances | Gas Appliances Regulation (EU 2016/426) |
Machinery (Certain Categories) | Machinery Directive (2006/42/EC) |
Construction Products | Construction Products Regulation (EU 305/2011) |
For low-risk products, self-certification is usually sufficient, and manufacturers can issue a Declaration of Conformity (DoC) without a Notified Body.
List of Notified Bodies
The European Commission maintains an up-to-date list of Notified Bodies on the NANDO (New Approach Notified and Designated Organizations) database. You can access the official list here: 🔗 NANDO Database - List of Notified Bodies
Examples of Notified Bodies for Medical Devices under MDR 2017/745
As of now, there are 20 Notified Bodies designated under the EU Medical Device Regulation (MDR 2017/745), including:
UDEM Adriatic d.o.o. (Croatia)
GMED (France)
Eurofins Expert Services Oy (Finland)
For products such as medical devices, specific Notified Bodies have been designated under EU MDR to ensure compliance with the latest regulations. The designation of Notified Bodies may change, so it is recommended to check the NANDO database for the most current information.
How to Find a Notified Body?
You can search for an authorized Notified Body using the EU NANDO database: 🔗 NANDO (New Approach Notified and Designated Organisations)
When selecting a Notified Body: ✔ Ensure they are accredited for your product category. ✔ Verify their scope of certification and expertise. ✔ Check their experience with EU directives applicable to your product.
Examples of Notified Bodies
TÜV Rheinland (Germany) – Testing and certification for medical devices, PPE, and industrial equipment.
BSI Group (United Kingdom, Netherlands) – Conformity assessment for medical devices and pressure equipment.
SGS Belgium NV (Belgium) – Certification for construction products, PPE, and gas appliances.
DEKRA Certification (Germany, Spain, Netherlands) – Notified Body for EMC, machinery, and medical devices.
LNE/G-MED (France) – Specialist in medical device certification under MDR 2017/745.
For the most up-to-date list, check the NANDO Database.
Notified Body vs. Approved Body (UK)
After Brexit, the UK replaced Notified Bodies with Approved Bodies for UKCA marking compliance. The role remains similar, but Approved Bodies assess products for the UK market under UK regulations.
Feature | Notified Body (EU) | Approved Body (UK) |
Regulatory Framework | EU Directives & Regulations | UK Regulations |
Certification Mark | CE Marking | UKCA Marking |
Market Coverage | European Economic Area (EEA) | United Kingdom (UK) |
If selling in both the EU and UK, you may need both a Notified Body (EU) and an Approved Body (UK).