Rates established for assessment of research under CTR and MDR
The Ministry of Health, Welfare and Sport has set the rates for medical ethical review in the Netherlands of research under the EU regulations for research with a medicinal product and clinical research with medical devices. These national rates will apply to assessments by the accredited MRECs and by CCMO. All other rates will continue to apply to the assessment of other medical research in the Netherlands.
The new rates will apply to the assessment of clinical research into:
- Medicinal products: Research files falling within the scope of the EU Clinical Trial Regulation 536/2014 (CTR) for research with a medicinal product.
- Medical devices: Research files carried out for conformity purposes, article 62/74.2 of the EU Medical Device Regulation 2017/745 (MDR). For other research files falling within the scope of the MDR (MDR article 74.1 or 82) the fee of the review committee concerned (accredited MREC or CCMO) applies instead of the national fee.
Effective date
The rates for the assessment of clinical research with medicinal products and with medical devices will apply from 31 January 2022. On this date, the CTR comes into effect as well. During the first year of the CTR, sponsors may opt for assessment of research with a medicinal product under the current legislation and regulations instead of under the CTR. In that case, the fee of the review committee concerned (accredited MREC or CCMO) applies. From 31 January 2023, the national fees will apply to all assessments of research with a medicinal product.
In the course of 2022, national rates will also be set for the assessment of clinical research with in-vitro diagnostic medical devices falling within the scope of the EU In Vitro Diagnostic Regulation 2017/746 (IVDR). These rates will apply from 2023 onwards.
Uniform national rate
The rates are based on research by an independent research agency and are in line with the current rates. The starting point is a uniform national fee per type of assessment. Lower rates apply to non-commercial research and resubmissions. The fees also apply to 'local researchers' who are affiliated with the same institution as the accredited MREC reviewing the study.
The rates apply to all accredited MRECs in the Netherlands and to CCMO. This means that CCMO will also collect fees for reviewing the types of research mentioned. For the time being, CCMO will continue to assess other medical research free of charge.
The fees will cover the maximum costs. This means that review committees do not make a profit. No VAT is charged for the review.
Annual adjustment
The Ministry of Health, Welfare and Sport can adjust the rates annually, taking effect from 1 January of the following year. CCMO will announce the adjustment annually before 1 July of the preceding year.
Collecting the fees
CCMO will collect the fees for the assessment of research falling within the scope of CTR or MDR. This means that CCMO will collect the fees charged for the assessment of these studies on behalf of both accredited MRECs and CCMO.
The fees of the relevant accredited MREC apply to assessments conducted under the current legislation and regulations during the CTR's transitional year. These fees are collected by the MREC concerned. This also applies to the assessment of other medical research falling outside the scope of CTR or MDR.
CCMO is currently working out the details of the way the fees will be charged. CCMO expects to inform you fully in December 2021.