The Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements. It will also make it easier for pharmaceutical companies to conduct multinational clinical trials, which should increase the number of studies conducted within the EU. More detailed information on the regulation is available on the European Medicine Agency (EMA)'s website.
Unlike the Directive, the Regulation will be binding in its entirety and will be directly applicable in all EU/EEA Member States: the 27 EU countries and Iceland, Liechtenstein and Norway – not including, of course, the UK following the Brexit.
The timelines for review will therefore be harmonized as well, and will mirror the current review timelines implemented in Spain, one of the countries which has already aligned its national law with the future Regulation. Sponsors will have options to defer the timing of publication of specific data/documents and the Member States will have the chance to evaluate the proposal made by sponsors to defer the publication, as applicable.
In the case of medical devices, the European Union Medical Device Regulation (EU MDR) defines a clinical investigation as “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.”
For Class III or Class II implantable medical devices, a clinical investigation is a necessary part of performing the clinical evaluation required to obtain a CE Marking and market your product in the EU. However, some Notified Bodies are requesting Clinical Investigations for devices of classes IIa or IIb. This will depends on the previous information and device development.
We can help you with your clinical trials acting as your EU Representative.
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