In brief

The AEMPS has published new guidelines on how conduct clinical investigations with medical devices, in order to adapt them to the EU Regulation 2017/745. The main changes include adjustments regarding the requirements for approval of clinical investigations, modifications to the procedures and deadlines and the documentation required. 

In more detail 

Context

The Spanish Agency of Medicines and Medical Products (AEMPS) has modified the procedure for applying for clinical investigation authorizations in order to bring them in line with Regulation 2017/745 on medical devices, as well as to introduce additional national requirements for sponsors. Furthermore, the new instructions are necessary for the correct implementation of the new Royal Decree 192/2023 on medical devices and the changes which it has introduced at national level regarding clinical investigations.

Requirements for the conduct of clinical investigations with medical devices

The new instructions have been published on the AEMPS website, and they differentiate between the following kinds of clinical investigations, which in turn are subject to different requirements:

• Investigations regarding medical devices without CE marking aimed to obtain product conformity assessment and investigations regarding CE marked medical devices for a new intended purpose: require prior authorization by the AEMPS, which is subject to a favorable opinion issued by an Ethics Committee. In addition, an agreement needs to be entered with the centers participating in the clinical investigation. 
• Investigations regarding CE marked medical devices according to the approved intended purpose: do not require prior authorization by the AEMPS, but require a favorable opinion issued by an Ethics Committee as well as an agreement with the centers participating in the clinical investigation. Furthermore, if the clinical investigation involves invasive procedures, the sponsor shall be required to notify the Member States concerned at least 30 calendar days before the start of the procedure. In Spain, notifications shall be made to the AMEPS for inclusion in the Notifications of Observational Studies of Medical Devices (NEOPS) database until the European Database on Medical Devices (EUDAMED) electronic system is operational.
• Other investigations with medical devices: the AEMPS must be consulted on the procedure to be followed, which will evaluate whether an authorization is needed.

Procedure and deadlines

The guidelines also include the process to be followed to apply for the research authorization and the documents that must accompany the request. Some of the most relevant differences between the previous and the current procedural requirements are as follow:

• New deadlines have to be taken into account throughout the procedure: 10 days for the verification of the application by the AEMPS and 45 days for the evaluation. In addition, if the clinical investigation is temporarily halted or terminated prematurely, the sponsor must notify the AEMPS within 15 calendar days; or within 24 hours if this is due to safety reasons.
• One year after the end of the investigation or three months later if the investigation is terminated early or temporarily interrupted, the sponsor must send a final report to the AEMPS. If the clinical investigation lasts longer than one year, the sponsor shall submit an annual report on the clinical investigation to the AEMPS.

For more information please access the guideline from the AEMPS through the following link.