Commission Publishes Updated List of Notified Bodies’ Standard Fees
The European Commission has published an updated list of notified bodies’ standard fees.
The list is published in fulfilment of the obligation imposed on Notified Bodies by Article 50 of the MDR and Article 46 IVDR to establish and publish lists of their standard fees. The information provided in the list is not binding on either the Notified Bodies or their clients. It is rather a reference document to help manufacturers determine potential costs related to interactions with Notified Bodies.
The list of standard fees will potentially become increasingly useful with the entry into application of the Commission Implementing Regulation standardising conformity assessment procedures by Notified Bodies. The Regulation includes rules for provision of cost estimates and timelines for review.
Cost estimates must include:
estimates of overall costs
estimates of potential extra costs
Estimated timelines
For first review
30 days for application review
120 days for QMS audit
90 days for product verification
20 days for decision and issue of Certificate of Conformity
For substantial changes
30 days for review of proposed changes
90 days for additional conformity assessment
20 days for issue of supplement to existing Certificates of Conformity
Permitted interruption of timelines
1 interruption during application review
4 interruptions during QMS audit
4 interruptions during product verification
5 interruptions in total during review of proposed substantial changes and related conformity assessment
3 interruptions in total during re-certification process
1 interruption for decision and certification of new applications, substantial changes, and re-certification
The Regulation will apply from 25 February 2027. Provisions of the Regulation governing cost and time estimates will not apply to agreements between notified bodies and manufacturers that are signed before this date. Moreover, provisions governing re-certification will not apply to reviews of certificates expiring before 25 November 2027.