Your Easy Guide to Clinical Studies

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

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.

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

MedDO – see in particular chapter

• Chapter 5 Designated bodies