NEW | IVDs Medical Devices Regulation

At European level, it has been considered necessary to establish a new solid, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices, that guarantees the highest level of safety and protection of patients and users health, and at the same time promotes innovation and the interests of small and medium-sized enterprises that carry out their activities in this sector.

At European level, it has been considered necessary to establish a new solid, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices, that guarantees the highest level of safety and protection of patients and users health, and at the same time promotes innovation and the interests of small and medium-sized enterprises that carry out their activities in this sector.
March 16, 2023

The Spanish Ministry of Health has published the draft of the Royal Decree on In Vitro Diagnostic Health Products. Although Regulation (EU) 2017/746 IVDR is directly applicable in the countries of the European Union, at a national level it is necessary to regulate the aspects that the European standard leaves each Member State govern.

Currently it is only a draft, hence subject to modifications, and additions and contributions can be made until April 3, 2023 through the following email: informacion.publica@sanidad.gob.es

You can read the complete draft here: https://www.sanidad.gob.es/normativa/audiencia/home.htm

For further queries or additional information you can contact us at: info@asphalion.com

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