What is it? Why is it important?

Notified Bodies (NB):

  • Are nationally accredited bodies, appointed by an EU country to perform product (medical device) conformity evaluations
  • Perform assessments based on uniform evaluation factors (e.g. calibration, testing, certification, audits)
  • Operate in a non-discriminatory, transparent, neutral, independent, and impartial manner

Medical Device (MD) manufacturers wanting to sell their products on the EU market must for:

  • Class I MDs self-certify that the product meets essential / conformity requirements
  • Class II and III receive a conformity approval (CE mark) from a Notified Body (NB)

With a product CE mark, the manufacturer:

  • Guarantees compliance with relevant health and safety requirements, as defined in the EU Directives and the EU Regulations
  • Takes full responsibility and liability over the product

What do I need to do?

MD manufacturers:

  • Are free to choose the NB of their choice. The EU commission publishes a list of accredited NBs
  • Must classify their MD based on the EU Medical Device Regulation

In the EU, Medical Devices (MD) are classified into three main classes, Class I, II (IIa and IIb), and III (e.g. including some sub-classes). The classification reflects the risk and required regulatory controls necessary to provide safety and efficacy assurance.

A NB certifies compliance with “Essential Requirements" regarding product characteristics, including other relevant guidelines and directives. If approved, it entitles the manufacturer to issue a "Declaration of Conformity" and to affix a CE mark on the MD.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

Swissmedic – see in particular

  • Designated bodies


European commission – see in particular

  • Notified bodies

EU Regulation MDR 2017/746 – see in particular

  • Chapter IV Notified bodies

MDCG – see in particular


  • 1 Notified bodies oversight

Swiss Law

MedDO – see in particular chapter

  • Chapter 5 Designated bodies
  • CE – Conformité Européenne
  • CTU – Clinical Trials Unit
  • EU – European Union
  • MD – Medical Device
  • MDCG – Medical Device Coordination Group
  • MedDO – Medical Device Ordinance
  • NB – Notified Body
Basic ↦ Ethics and Laws ↦ Medical Device Ordinance ↦ Notified Bodies

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Basic ↦ Ethics and Laws ↦ Medical Device Ordinance ↦ Notified Bodies

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