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

doi:10.7399/fh.13178

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

Texto completo:

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Referencias

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DOI: http://dx.doi.org/10.7399%2Ffh.13178