New regulatory framework for in vitro diagnostic medical devices in Spain

10
Nov

The Council of Ministers has approved the new Royal Decree on in vitro diagnostic medical devices, a regulation that adapts Regulation (EU) 2017/746 to the national context, with the aim of strengthening safety, quality and transparency in a key sector for the healthcare system.

The aim of this update is twofold: to ensure maximum protection for the health of patients and users, while at the same time promoting innovation and sustainability in the diagnostics industry.

The text defines the regulatory framework that will govern these products for human use — as well as their accessories — and details the authorisation procedures, requirements for performance studies, and conditions for marketing and control.

In this scenario, the Spanish Agency for Medicines and Health Products (AEMPS) will act as the competent authority for its implementation, in coordination with the autonomous communities.

Among the most noteworthy points of the new Royal Decree are:

  • The regulation of the in-house manufacture of products, that is, those manufactured in healthcare centres for the use of healthcare professionals, is subject to specific requirements. those produced in healthcare centres for their own use, which must be notified to the AEMPS and comply with specific requirements relating to their a23> quality and safety.
  • The obligation to obtain informed consent expressly given for genetic testing, together with the provision of clear information about its a17> purpose and consequences.
  • The definition of the procedure for the designation of reference laboratories a8> the laboratories of reference European with headquarters in Spain.
  • The creation of a mandatory national marketing register for economic operators placing these products on the market.
  • The clarification that self-diagnostic products —such as pregnancy or glucose tests— do not require a medical prescription, although their sale remains limited to authorised physical or digital pharmacies.
  • The establishment of national requirements for performance studies, including the obligation to provide coverage against possible harm to participants.
  • The organisation of a reinforced system of market surveillance, inspection and control, coordinated by the AEMPS together with the regional health authorities.
  • The regulation of the import and export of products, in order to ensure their traceability and compliance with current regulations.

This regulation replaces Royal Decree 1662/2000, although some articles of the previous regulation will continue to apply on a transitional basis until the new framework is fully implemented.

Furthermore, it empowers the Ministry of Health to issue the necessary complementary necessary and ensure a correct technical adaptation adaptation.

To facilitate the transition, the AEMPS has organised an online information session, to be held on 4 December, aimed at professionals and stakeholders in the sector, which will address the main changes and their practical application.

CQS is the first and only designated private clinical reference laboratory in the EU for two categories of Class D in vitro diagnostic medical devices:

  • products intended for the detection or quantification of herpesvirus markers, and
  • products for the detection and quantification of bacterial infection markers.

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