The European (MDCG) has issued new guidance on standard fees for the MDR and IVDR. MDCG published guidance on lists of standard fees Notified Body (NBs) must disclose regarding conformity assessment and certification services under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation. Articles 50 of MDR and 46 of IVDR compel NBs (notified body) to publicly disclose and make available their standard fees, according to the new MDCG paper MDCG 2023-2, although the Regulations do not define what “standard fees” exactly entails. A NB’s list of standard fees must contain a minimum amount of content, as specified in MDCG 2023-2, which was published to clarify this definition.
When NBs are developing their own lists of fees for publishing, the guidance refers to lists of standard charge forms in both the MDR and IVDR. Although a Notified Body is free to choose its price structure, it is required to be open and transparent. Items should also be made very clear in a Notified Bodies published list of normal costs. All regularly offered activities that fall under the scope of an NB’s (notified body) designation and conformity assessment activities should always be covered by published price lists.
The new guidance enables medical device manufacturers and IVD manufacturers to generate more accurate estimation of CE mark certification under MDR and/ or IVDR. This guidance encourages NBs (Notified body) to publish details of their policies and hence this guidance is useful for small and medium sized enterprises (SMEs).
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