Basic↦Ethics and Laws↦Medical Device Ordinance↦Notified Bodies
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?
- 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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
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
FEDLEX – law is available online under number
- 812.213 MedDO
MedDo – see in particular chapter
- Chapter 5 Designated bodies