Yesterday, the Council of Ministers approved the text of the new Royal Decree on Medical Devices for in vitro diagnostics. This new RD 55/2025 complements European legislation (Regulation (EU) 2017/746) and allows it to be developed, in those points that are left in the hands of each member state of the European Union. And therefore, this regulation will apply only within the Spanish national scope.
As the AEMPS informs us, in a press release issued yesterday, the new Royal Decree 55/2025 delves into different aspects that the Regulation (EU) 2017/746 is left to each Member State.
The Regulation allows member states to create their own legislation in the following areas:
- The determination of the competent authority for the purposes of the regulation and the establishment of the language regime.
- The manufacture of products for use in the health care facility itself (commonly referred to as the "in-house" or "in-house" production). in house).
- Genetic testing, genetic information and the necessary pre- and post-test counselling.
- European reference laboratories.
- The characteristics of the marketing register in Spain.
- Diagnostic medical devices in vitro subject to prescription, eliminating the need for prescription for self-testing products and maintaining their sale exclusively through pharmacies or directly through the pharmacy's own website.
- National requirements for the authorisation of performance studies.
- Market surveillance and control obligations.
- Foreign trade requirements for economic operators.
The Royal Decree 55/2025, It also repeals the previous legislation in this area, i.e. the Royal Decree 1662/2000, of 29 September 2000..
AEMPS organises an informative seminar on the new Royal Decree on Medical Devices for in vitro diagnosis
The Spanish Agency for Medicines and Health Products (AEMPS), which has been in charge of drafting this new Royal Decree on Medical Devices for in vitro diagnostics, has organised an informative session on the new law. online on the aspects regulated in the new text. At this information day, which will be held online on 4 December, The new regulation will be presented to the main sectors involved, which have already been informed throughout the drafting and approval process of the new Royal Decree.
Registration for the event is now available and will also be available at streaming through the Linkedin and YouTube accounts of the AEMPS.