{"id":22605,"date":"2020-03-16T09:33:08","date_gmt":"2020-03-16T08:33:08","guid":{"rendered":"https:\/\/faus-moliner.com\/productos-sanitarios-y-seguridad-juridica\/"},"modified":"2020-03-16T13:18:23","modified_gmt":"2020-03-16T12:18:23","slug":"medical-devices-and-legal-certainty","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/medical-devices-and-legal-certainty\/","title":{"rendered":"Medical devices and legal certainty"},"content":{"rendered":"\n

On May 26th<\/sup> we will probably have overcome the coronavirus crisis already, but my article today is not about this. It is about the new Regulation 2017\/745 on medical devices, which will enter into force on that day. According to its Preamble, the Regulation aims to ensure the proper functioning of the internal market in the EU and to maintain a high level of health protection for patients and users. In the same paragraph, the European legislator says that “the interests of small and medium-sized enterprises that are active in this sector\u201d should also be taken into account. Whenever I encounter a rule that mentions the idea of reconciling public and private interests, I think we are on the right track, because I believe that approaching the regulation of any situation from unnecessarily aggressive positions against companies does not make sense.<\/p>\n\n\n\n

With this\nin mind, do you know what has always been one of the biggest concerns of\ncompanies? Something as simple as legal certainty, the absence of regulatory\nconfusion and predictability in the application of the law, to be able to know\nwhich law applies. The Regulation, also in its Preamble (paragraph 15), speaks\nof ensuring a \u201chigh level of health protection, free movement of goods and\nlegal certainty for manufacturers\u201d. In paragraphs 20 and 36 there are two\nfurther references to the desirability of promoting legal certainty.<\/p>\n\n\n\n

Two months\nbefore the entry into force of the Regulation, we are not on the right track,\nand not because of the coronavirus, but because various administrations (both\nin Spain and in the European Union) have decided to set the criteria on several\nissues relating to the application of this law using a Q&A document which\n(at least in its Spanish version) begins with a warning not to be missed: \u201cThe\ninformation presented in this document is for the purpose of general\ninformation only and is not intended to represent legal advice to any\nindividual or entity. It reflects the outcome of discussions within the\nTransition Sub Group (TSG) of the CAMD\u2026 to establish recommendations on the\ninterpretation of transition-related provisions. It is not intended to be a\nguidance document. We recommend that you should obtain your own legal advice\nbefore taking any action based on information given here. The content of this\nFAQ table will be updated continuously. While we strive to provide the\nfollowing information in as timely and accurate a manner as possible, this\ndocument does not make any claims or guarantees about the accuracy,\ncompleteness or sufficiency of its contents.\u201d<\/p>\n\n\n\n

Despite\nthis warning, more than one administration is acting as if this Q&A\ndocument was the Constitution!<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

On May 26th we will probably have overcome the coronavirus crisis already, but my article today is not about this. It is about the new Regulation 2017\/745 on medical devices, which will enter into force on that day. According to its Preamble, the Regulation aims to ensure the proper functioning of the internal market in… <\/p>\n

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Read More<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[499,71],"tags":[],"coauthors":[],"class_list":["post-22605","post","type-post","status-publish","format-standard","hentry","category-el-global","category-publications"],"acf":[],"yoast_head":"\nMedical devices and legal certainty - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/en\/medical-devices-and-legal-certainty\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical devices and legal certainty - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"On May 26th we will probably have overcome the coronavirus crisis already, but my article today is not about this. 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