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. Swissmedic publishes a list of accredited NBs in Switzerland
  • 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

References

European commission – see in particular

  • Notified bodies

EU Regulation MDR 2017/746 – see in particular

  • Chapter IV Notified bodies

MDCG – see in particular

Section

  • 1 Notified bodies oversight

Swiss Law

FEDLEX – law is available online under number

  • 812.213 MedDO

MedDo – see in particular chapter

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

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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