The Aemps announces changes to the regulation of in vitro diagnostic products

The Aemps announces changes to the regulation of in vitro diagnostic products
The Aemps announces changes to the regulation of in vitro diagnostic products

The Spanish Agency for Medicines and Medical Devices (AEMPS) announced on Tuesday the modification of Regulations 2107/745 on Medical Devices and 2017/746 on Medical Devices for In Vitro Diagnostics, through Regulation (EU) 2024/1860. This regulation, which comes into force this Tuesday, includes three new features.

First add a Extension of the transitional periods of Regulation 2017/746thus giving companies and notified bodies more time to certify products and thereby mitigating the risk of shortages, especially of high-risk products used, for example, to detect infections in blood or organ donations or to determine blood type for transfusions.

This extension is subject to certain conditions, so only products that are safe and for which their manufacturers have started the process of transition to the new regulation will be able to benefit from this additional time.

On the other hand it allows The gradual implementation of integrated electronic systems (modules) in Eudamed ―the European Medical Devices Database― which are complete, rather than postponing the mandatory use of this database until the last of the six modules is completed.

The use of Eudamed, and in particular its registration systems for economic agents, products and certificates, will improve transparency and provide information on products on the European Union market, helping to monitor product availability.

Finally includes a new obligation for manufacturers to provide advance notice in the event of interruption or cessation of the supply of certain essential medical devices and in vitro diagnostic medical devices, where such interruption or cessation may cause serious harm or a risk of serious harm to patients or public health.

The AEMPS has also indicated that, together with the rest of the competent European authorities, it will continue to collaborate and support the different economic agents to facilitate the proper implementation of this modification.

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