New scenario in the field of medical devices in the European Union: Switzerland and the United Kingdom become third countries.

OBJECTIVE: To compare the measures taken by the European Union,  Switzerland and the United Kingdom to ensure the continuity of the medical  devices 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 and Health  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 January 2020 to December 2021. RESULTS: As a result of the disappearance of the legal framework  that supported free trade between Switzerland, the United Kingdom and  the European Union, products that used to be unrestrictedly distributed in Europe have become imports having to comply with the relevant legal  requirements. 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 no  longer recognized by the European Commission. Switzerland, the United Kingdom and the European Union have had to grant grace periods to allow  regulatory agencies and economic operators to adapt to the new situation. CONCLUSIONS: The transition period toward the new economic scenario has not  yet ended. Both Switzerland and the United Kingdom have had to take  stronger measures than the EU to adapt to the changes. Both Switzerland and  the United Kingdom are expected to finally incorporate the requirements of the  new Regulation in their internal legal systems.

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.

American and European legislation on border medical devices.

INTRODUCTION: Borderline medical devices are products in a 'gray area,' this means due to their characteristics, they could belong to different 'legal products.' In addition, regulation is a controversial topic and may change depending on the country which may put public health at risk and distort the market. AREAS COVERED: This article analyzes how borderline medical devices are managed in the American and the European legislation. We compared the decisions made by both regulations on the devices of the Manual on Borderline and Classification Medical Devices of the European Commission for the first three sections, those which deal exclusively with medical devices. EXPERT OPINION: Borderline medical devices do not have to be understood as something specific to each country. The different classification of products creates international borders. It is necessary to create working groups in international organizations in which global consensus is reached. Although a priori it seems that the American system could be more efficient, studies with quantitative data from authorized devices are needed to show that. Until EUDAMED is not fully operational and open access, it will not be possible to develop them.

Borderline products do not have a simple product classification and can be managed differently depending on different countries. The different classification between countries has economic consequences for companies and patients. In this article, the American and European regulations system is compared, specifically borderline products, using as a tool the Borderline and Classification Manual of the European Commission. Results show the international consensus is necessary to avoid barriers to trade and contribute to innovation. Although both regulations have points of improvement, with the data from the Manual (EU), it seems that American regulatory system could be more efficient, although copying some of its strengths could be complicated due to the intrinsic characteristics of the European system. However, studies with quantitative data are needed to corroborate this statement.

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

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)

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)

Mascarillas en el contexto de la COVID-19: aspectos legales y utilización / Face masks against the background of the COVID 19 pandemic: legal considerations about their use

Objetivo: Revisar los requisitos de calidad y usos recomendados de losdiferentes tipos de mascarillas con objeto de optimizar su uso y facilitar laidentificación de los productos no conformes.Método: Se hizo una búsqueda bibliográfica en PubMed, en el BoletínOficial del Estado y Eudralex; se revisaron las páginas web de los Ministerios de Industria, Comercio y Turismo y Sanidad, así como las normasUNE.Resultados: Los diferentes tipos de mascarillas que se pueden encontrar en el mercado se acogen a diferentes exigencias regulatorias. Lasmascarillas higiénicas no se consideran productos sanitarios ni equipode protección individual y no necesitan autorización. No llevan marcado CE y deben cumplir con la normativa general de los productosde consumo. Para las mascarillas quirúrgicas, los criterios de calidadestán definidos en la UNE-EN 14683:2019, son productos sanitarios declase I según el Reglamento (UE) 745/2017, se les requiere declaraciónUE de conformidad y debe colocar el marcado CE en el producto. Lasmascarillas filtrantes son equipos de protección individual de categoría III, están reguladas por el Reglamento (UE) 2016/425 y deben llevarmarcado CE conforme al mismo. Por otro lado, los instrumentos de control de mercado han detectado mascarillas fraudulentas, por ello, antecualquier duda se debe solicitar información adicional al fabricante oproveedor. (AU)

Objective: The objective of this article is to review the quality requirements and recommended uses of the different types of face masks witha view to helping optimize their use and facilitating identification of nonconforming products.Method: A literature search was conducted in PubMed, the SpanishOfficial State Gazette and Eudralex. The websites of the Ministry of Industry, Commerce and Tourism and of the Ministry of Health, as well as therelevant UNE standards were also reviewed.Results: The different types of face masks available on the market meetdifferent regulatory requirements. Community masks are not consideredmedical devices or personal protective equipment and do not require marketing authorization. They do not carry a CE mark and need not complywith the general regulations applicable to consumer products. Surgicalmasks, for their part, must meet the quality criteria defined in UNE-ENstandard 14683: 2019. According to Regulation (EU) 745/2017 they areclass I devices, subject to an EU declaration of conformity, and must beara CE mark. Filtering masks are considered category III personal protectiveequipment, regulated by Regulation (EU) 2016/425, and must also beara CE mark. In spite the abundant regulations in place, market controlinstruments have detected counterfeit face masks, which means that publicauthorities and users should ask manufacturers or suppliers for additionalinformation in case of doubt. (AU)

Face masks against the background of the COVID 19 pandemic: legal considerations about their use.

OBJECTIVE: The objective of this article is to review the quality  equirements and recommended uses of the different types of face masks  with a view to helping optimize their use and facilitating identification of  nonconforming products. METHOD: A literature search was conducted in PubMed, the Spanish Official State Gazette and Eudralex. The websites of the Ministry of Industry, Commerce and Tourism and of the Ministry of Health, as well as  the relevant UNE standards were also reviewed. RESULTS: The different types of face masks available on the market meet different regulatory requirements. Community masks are not  considered medical devices or personal protective equipment and do not  require marketing authorization. They do not carry a CE mark and need  not comply with the general regulations applicable to consumer products.  Surgical masks, for their part, must meet the quality criteria defined in  UNE-EN standard 14683: 2019. According to Regulation (EU) 745/2017  they are class I devices, subject to an EU declaration of conformity, and  must bear a CE mark. Filtering masks are considered category III personal protective equipment, regulated by Regulation (EU) 2016/425, and must  also bear a CE mark. In spite the abundant regulations in place, market  control instruments have detected counterfeit face masks, which means  that public authorities and users should ask manufacturers or suppliers for  additional information in case of doubt. CONCLUSIONS: The legal and quality requirements of the masks are  sufficient for their safe use. It is necessary for the general public to know  these requirements to avoid the fraudulent use of high consumption  products.

Objetivo: Revisar los requisitos de calidad y usos recomendados de los diferentes tipos de mascarillas con objeto de optimizar su uso y facilitar la identificación de los productos no conformes.Método: Se hizo una búsqueda bibliográfica en PubMed, en el Boletín Oficial del Estado y Eudralex; se revisaron las páginas web de los  Ministerios de Industria, Comercio y Turismo y Sanidad, así como las  normas UNE.Resultados: Los diferentes tipos de mascarillas que se pueden encontrar en el mercado se acogen a diferentes exigencias regulatorias.  Las mascarillas higiénicas no se consideran productos sanitarios ni equipo de protección individual y no necesitan autorización. No llevan  marcado CE y deben cumplir con la normativa general de los productos de  consumo. Para las mascarillas quirúrgicas, los criterios de calidad están  definidos en la UNE-EN 14683:2019, son productos sanitarios de clase I  según el Reglamento (UE) 745/2017, se les requiere declaración UE de  conformidad y debe colocar el marcado CE en el producto. Las mascarillas  filtrantes son equipos de protección individual de categoría III, están  reguladas por el Reglamento (UE) 2016/425 y deben llevar marcado CE  conforme al mismo. Por otro lado, los instrumentos de control de mercado  han detectado mascarillas fraudulentas, por ello, ante cualquier duda se  debe solicitar información adicional al fabricante o proveedor.Conclusiones: Los requisitos legales y de calidad de las mascarillas son  suficientes para su uso seguro. Es necesario que el público general conozca estos requisitos para evitar el uso fraudulento de estos  productos de alto consumo.