CTR, IVDR and MDR
CTR, IVDR and MDR
Information about EU Regulation 536/2014 (Clinical Trial Regulation, CTR), EU Regulation 2017/746, also known as the In Vitro Diagnostics Regulation (IVDR), and EU Regulation 2017 /745 (Medical Device Regulation, MDR).
Clinical Trials Regulation (CTR) uitklapper, klik om te openen
Clinical trials with medicinal products
Since January 31, 2023, all new applications for clinical trials with medicinal products are subject to the CTR and must be submitted through the Clinical Trials Information System (CTIS). The website of the CCMO provides more about the Clinical Trial Regulation (CTR).
In Vitro Diagnostics Regulation (IVDR) uitklapper, klik om te openen
Performance studies using in-vitro diagnostics (IVDR)
On 26 May 2022, EU Regulation 2017/746, also known as the In-Vitro Diagnostics Regulation (IVDR), entered into force.
IVDs must comply with the new European rules from May 26, 2022.
Information on the submission, review and conduct of performance studies on in vitro diagnostic medical devices (IVDs) can be found on the website of the CCMO.
Medical Device Regulation (MDR) uitklapper, klik om te openen
Clinical research with medical devices
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745 (MDR)) entered into force. As a result, the rules for submission, review and conduct of clinical research with medical devices have changed.
As soon as a study relates to the safety or performance of a medical device (also software or app) the MDR-regulation applies.General information can be found on the CCMO website 'clinical investigations with medical devices'.
When in doubt, please seek advice from the relevant department of your own institution.
Algemene informatie vindt u op de CCMO website onder 'Onderzoek met medische hulpmiddelen'
Submission of the file
First consult the CCMO website to determine whether submission should be made to the CCMO or to the MREC.
It is important to clearly describe the purpose of the research. If you believe, for example, that a particular app or other device does not fall within the scope of the MDR, then please substantiate this.