The work of Notified Bodies (“NBs”) in the Conformity Assessment and Certification of
Medical Devices (MD) and In-Vitro Diagnostic Devices (IVD) continues to be a key corner stone of the EU legislative system to safeguard public health. This role creates a strong interest in public opinion and among other stakeholders, such as European and national authorities.
Regulations that entered into force in 2017 (MDR (EU) 2017/745 and IVDR (EU) 2017/746)
have an Annex VII dedicated to the Requirements to be met by NBs.
The update to the CoC in 2024 reflects the current applicable legislation and guidance
documents. Only aspects of conformity assessment that benefit from some detail to enhance consistency are covered. All references to obsolete legislation (93/42/EEC, 90/384/EEC and 98/79/EC) are removed. References to guidance, standards and mandatory documents from the International Accreditation Forum (IAF) are updated…
Europe – Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746
Improving implementation of the European CE certification of medical devices through the harmonisation of Notified Bodies
