AEMPS Launches New App for Hospital-Made Medical Devices

The Spanish Agency for Medicines and Medical Devices (AEMPS) has launched a new digital platform that enables hospitals in Spain to notify the agency before beginning the manufacture of certain medical devices in-house. This initiative comes as part of the regulatory measures outlined in the Royal Decree 192/2023 of March 21, which governs the manufacture of medical devices within healthcare facilities.

How Does the AEMPS App Help Hospitals Ensure Compliance?

The new application serves as a streamlined notification system, specifically designed to ensure compliance and traceability of medical devices manufactured within hospital settings. According to the decree, this capability is strictly limited to hospitals and applies only to Class I and IIa medical devices. These classes include devices with lower risks to patient health, such as certain diagnostic tools and equipment for monitoring or supporting patient care.

More advanced medical devices, classified as Class IIb, Class III, implantable, or custom-made devices, are excluded from this authorization. The restriction reflects a careful approach by Spanish regulators to limit in-hospital manufacturing to simpler devices with manageable risks, thereby ensuring patient safety while allowing flexibility for hospitals to address specific medical needs in real-time.

What Impact Will the New Application Have on Hospital Compliance?

This step marks a significant move by AEMPS to incorporate digital tools into regulatory oversight, aiming to simplify the compliance process for hospitals and enhance the transparency of in-house medical device production. By standardizing the notification process, AEMPS seeks to support hospitals in meeting regulatory standards without compromising their operational efficiency.

The launch of this application aligns with broader European trends, where regulatory bodies are increasingly leveraging technology to ensure compliance with medical device regulations.

The complete document can be read here.

_____________________________________________

If you need guidance in understanding how the AEMPS app works for Spanish hospitals, please don’t hesitate to contact us. Our team is here to help navigate the evolving regulatory landscape.

Learn how MedEnvoy can assist you:

• • • EU Authorized Representative
    • EU Regulatory Importer
    • EUDAMED Registration Management