Nuevo escenario en el ámbito de los productos sanitarios en la Unión Europea: Suiza y Reino Unido se convierten en terceros países

Miriam Fraga-García, Raquel Taléns-Visconti, Amparo Nácher-Alonso, Octavio Díez-Sales

Resumen


Objetivo: Comparar las medidas que se han tomado por parte de la Unión  Europea, Suiza y Reino Unido para mantener la continuidad de mercado  cumpliendo con los requisitos regulatorios del Reglamento 745/2017 de   productos Sanitarios.

Método: Para realizar este trabajo se han revisado las webs oficiales de la  omisión Europea, la Agencia Española del Medicamento y Productos Sanitarios,  la Swiss Agency for Therapeutic Products y la Medicines and  Healthcare Products Regulatory Agency del Reino Unido y se han realizado  búsquedas bibliográficas en PubMed y en internet (Google) con términos como  “withdrawal Mutual Recognition Agreement of certificates of conformity  European Union Switzerland medical devices, new regulation medical devices  UK” y similares para un periodo comprendido entre enero de 2020 y diciembre  de 2021.

Resultados: Como resultado del cese del marco legal que sostenía el libre  comercio entre Suiza y Reino Unido de la Unión Europea, la distribución de  productos sanitarios se ha convertido en una importación, teniendo que  cumplir con los requisitos legales pertinentes. Los distribuidores han pasado a  ser importadores, y las declaraciones de conformidad y certificados de  Conformidad Europea han perdido su validez. Además, los Organismos  Notificados ya no son reconocidos por la Comisión EuroAbstract  pea. En  consecuencia, Suiza, Reino Unido y la Unión Europea han tenido que conceder  periodos de gracia para permitir a las agencias reguladoras y operadores  conómicos adaptarse a las nuevas condiciones.

Conclusiones: El periodo de transición para la adaptación al nuevo escenario económico todavía no ha concluido. Además, el Reglamento acaba de entrar plenamente en vigor, por lo que se creará normativa de desarrollo que deberá implementarse también en estos países. Por tanto, será necesaria una nueva reglamentación que permita abordar estos aspectos. 

 


Palabras clave


Producto sanitario; Acuerdo de Reconocimiento Mutuo; Suiza; Reino Unido; Irlanda del Norte; Reglamento

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Referencias


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