Nuevo escenario en el ámbito de los productossanitarios en la Unión Europea: Suiza y Reino Unido se convierten en terceros países / New scenario in the field of medical devices in the European Union: Switzerland and the United Kingdom become third countries

RESUMEN

Objetivo: Comparar las medidas que se han tomado por parte dela Unión Europea, Suiza y Reino Unido para mantener la continuidadde mercado cumpliendo con los requisitos regulatorios del Reglamento 745/2017 de Productos Sanitarios.Método: Para realizar este trabajo se han revisado las webs oficialesde la Comisión 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 hanrealizado búsquedas bibliográficas en PubMed y en internet (Google)con términos como “withdrawal Mutual Recognition Agreement of certificates of conformity European Union Switzerland medical devices, newregulation medical devices UK” y similares para un periodo comprendidoentre enero de 2020 y diciembre de 2021.Resultados: Como resultado del cese del marco legal que sosteníael libre comercio entre Suiza y Reino Unido de la Unión Europea, ladistribución 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 conformidady certificados de Conformidad Europea han perdido su validez. Además,los Organismos Notificados ya no son reconocidos por la Comisión Europea. En consecuencia, Suiza, Reino Unido y la Unión Europea han tenidoque conceder periodos de gracia para permitir a las agencias reguladoras y operadores económicos adaptarse a las nuevas condiciones. (AU)

ABSTRACT

Objective: To compare the measures taken by the European Union, Switzerland and the United Kingdom to ensure the continuity of the medicaldevices market, complying with the requirements of Regulation 2017/745.Method: To carry out this work, a review was made of the official websites of the European Commission, the Spanish Agency for Medicines andHealth Products, the Swiss Agency for Therapeutic Products and the Medicines and Healthcare Products Regulatory Agency of the United Kingdom.Bibliographic searches were also conducted on Pubmed and the internet(Google), using terms such as “withdrawal of the Mutual Recognition Agreement of Swiss European Union medical device conformity certificates,new UK medical device regulation”, for a period extending from January2020 to December 2021.Results: As a result of the disappearance of the legal framework thatsupported free trade between Switzerland, the United Kingdom and theEuropean Union, products that used to be unrestrictedly distributed inEurope have become imports having to comply with the relevant legalrequirements. Distributors for their part have become importers, and declarations of conformity and CE certificates have lost their validity. Furthermore, notified bodies from Switzerland and the United Kingdom are nolonger recognized by the European Commission. Switzerland, the United Kingdom and the European Union have had to grant grace periods toallow regulatory agencies and economic operators to adapt to the newsituation. (AU)