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: [email protected]
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: [email protected]
