Breaking Down Notified Bodies’ Standard Fees: What You Need to Know

The European Commission’s Medical Device Coordination Group (MDCG) has issued new guidance on the standard fees that Notified Bodies (NBs) must publish for conformity assessment and certification services under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

The MDCG explains that Article 50 of the MDR and Article 46 of the IVDR require NBs to disclose and make their standard fees available to the public. However, the regulations do not provide a clear definition of what “standard fees” means.

The MDCG 2023-2 guidance references the definition of “standard fees” and outlines the minimum content that should be included in an NB’s list of standard fees. This move aims to standardize fee disclosure practices for NBs, making it easier for medical device manufacturers to compare prices and choose the right NB.

If you’re interested in learning more about the MDCG’s guidance on Notified Bodies’ standard fees, you can read the full document here.