January 17, 2023
By Annette van Raamsdonk
The European Commission's Medical Device Coordination Group (MDCG) has published long-awaited guidance on lists of standard fees Notified Bodies (NBs) must disclose regarding conformity assessment and certification services under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
The new MDCG document, MDCG 2023-2, notes that Article 50 MDR as well as Article 46 IVDR require NBs to publicly disclose and make available their standard fees; however, the Regulations do not set a clear definition of what the term "standard fees" means. MDCG 2023-2 was issued to clarify that definition, and to list minimum content needed to be included in an NB's list of standard fees.
The guidance references lists of standard fee forms in both the MDR and IVDR, which are intended to assist NBs when defining their individual lists of fees for publication. An NB can decide how it charges for services, but fee setting must be transparent. Furthermore, items should be clearly indicated in an NB's published list of standard fees. Published fee lists should always cover all activities corresponding to the scope of an NB's designation and conformity assessment activities on regular offer.
In addition, NBs may charge fees on either a "flat fee" or "time-based fee" basis, according to MDCG 2023-2.
The new guidance allows medical device and IVD manufacturers to make more informed estimates of costs related to CE Mark certification under the MDR and/or IVDR. Small and medium-sized enterprises (SMEs) should find MDCG 2023-2 especially useful as the guidance requires NBs to provide indications of their policies as to how they take interests of SMEs into account when setting fees. (Targeted support for SMEs was one of the recommendations made under MDCG 2022-14.)
Annette van Raamsdonk is Lead Quality & Regulatory Affairs Consultant at Emergo by UL.
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