The Directive 93/42/EEC did not regulate in depth the clinical investigations with medical devices and most was delegated to the technical standard ISO 14155.
However, starting from the full application of the new Regulation 2017/745 (MDR) on 26th May 2020, the legislation on this aspect will acquire its own legal autonomy.
The MDR has introduced and defined the following points:
- Informed Consent
- Substantial and Non-Substantial Amendments
- Specific Rules for Risk Populations (e.g. pediatric population, pregnant or breastfeeding women)
- Damage Compensation
- Electronic System (EUDAMED) for the notification and management of the clinical trials (including vigilance and incidents reporting)
The MDR clearly distinguishes the clinical investigation between pre-market clinical trials in the context of the clinical evaluation for the conformity assessment; post-market clinical trials on CE marked medical devices according to the intended use and post-market clinical trials in the context of the clinical evaluation with different purposes from the conformity assessment (e.g. addition of a new indication).
The pre-market clinical investigations have become a cornerstone of the clinical evaluation according to the MDR. As a matter of fact, class III and implantable medical devices are clearly required to have substantial clinical investigation data to demonstrate the conformity with the relevant safety and performance requirements (for further details on this topic read our dedicated article).
The approval procedure for a pre-market clinical study foresees the validation and the following assessment of the trial application submitted by the sponsor to the interested Member State’s Competent Authority.
The trial application basically consists in the documentation pointed out in Annex XV, part 2 of the MDR, and it should be submitted to the interested Member State through the new electronic system EUDAMED (once it will be activated).
In particular, the trial application should contain:
- Application form
- Investigator’s Brochure
- Clinical investigation plan
- Other information (e.g. the opinion of the ethics committees)
The Member State shall inform the sponsor whether the application is validated (i.e. the application falls within the scope of the MDR and can be evaluated) within 10 days from the notification date.
- For class I, and not-implantable medical devices of class IIa and IIb the sponsor is immediately allowed to begin the clinical investigation starting from the validation of the application (unless a negative opinion by an ethic committee).
- For class III and implantable medical devices the Member State has 45 days starting from the validation date to perform the clinical investigation assessment and transmit the relevant report to the sponsor. The sponsor will be allowed to start the clinical investigation once he receives the Member State authorization (unless a negative opinion by an ethic committee).
Regulatory Pharma Net is available to support companies in each of the regulatory steps for the clinical investigations. Do not hesitate to contact us for further information!