{"id":3872,"date":"2020-02-17T11:06:40","date_gmt":"2020-02-17T10:06:40","guid":{"rendered":"https:\/\/www.m-q.ch\/?p=3872"},"modified":"2020-02-25T13:47:56","modified_gmt":"2020-02-25T12:47:56","slug":"prodotti-medtech-industria-svizzera-sotto-pressione","status":"publish","type":"post","link":"https:\/\/www.m-q.ch\/it\/medtech-produkte-schweizer-branche-unter-druck\/","title":{"rendered":"Prodotti MedTech: Industria svizzera sotto pressione"},"content":{"rendered":"
\"\"
Dal 26 maggio, nuove regole di approvazione per i prodotti medtech saranno applicate nell'UE. (Immagine: Unsplash)<\/figcaption><\/figure>\n

Il 26 maggio, nuove regole per l'approvazione di numerosi prodotti medtech entreranno in vigore nell'UE. Se per allora il comitato misto non avr\u00e0 incorporato queste regole nell'accordo del 1999, la Svizzera diventer\u00e0 un normale paese terzo in questo settore. Allora potrebbero non essere solo i nuovi prodotti medtech provenienti dalla Svizzera a dover essere approvati una seconda volta nell'UE.<\/p>\n

L'industria medtech svizzera potrebbe essere colpita dallo stallo nelle relazioni tra la Svizzera e l'UE. L'UE si rifiuta di aggiornare gli accordi bilaterali esistenti. Questo colpisce in particolare il\u00a0Accordo sul riconoscimento reciproco in materia di valutazione della conformit\u00e0<\/a>\u00a0uno dei sette accordi bilaterali I. Questo regola quali regolamenti sono riconosciuti come equivalenti nell'UE e in Svizzera.<\/p>\n

I nuovi regolamenti devono essere incorporati nell'accordo da un comitato congiunto di entrambe le parti. Questo \u00e8 stato fatto l'ultima volta nel 2017.<\/p>\n

Piuttosto, secondo un\u00a0Segnala<\/a>\u00a0la \"Neue Z\u00fcrcher Zeitung\", \u00e8 possibile che i prodotti esistenti per i quali l'approvazione svizzera era precedentemente sufficiente vengano riapprovati anche nell'UE. Questo significa che un numero sette volte maggiore di prodotti sarebbe interessato dal blocco rispetto a quanto ipotizzato in precedenza. Inoltre, le aziende svizzere dovrebbero nominare un rappresentante autorizzato nell'UE per assumere la responsabilit\u00e0 dei prodotti.<\/p>\n

L'UE ha un notevole margine di manovra nel decidere come sar\u00e0 trattata l'industria medtech svizzera. \"Una possibile interpretazione presuppone che in una fase di transizione fino al 2024, anche i nuovi prodotti devono continuare ad essere riconosciuti\", Peter Studer, dell'associazione industriale\u00a0Swiss Medtech<\/a>\u00a0responsabile della regolamentazione, in un\u00a0Segnala<\/a>\u00a0del \"Tages-Anzeiger\". Ma l'incertezza pesa sull'industria.<\/p>\n

L'accordo quadro istituzionale, che \u00e8 il cuore del blocco bilaterale, rimane su un terreno traballante.<\/p>","protected":false},"excerpt":{"rendered":"

Am 26. Mai treten in der EU neue Regeln f\u00fcr die Zulassung zahlreicher MedTech-Produkte in Kraft. Wenn bis dahin der gemischte Ausschuss diese Regeln nicht in das Abkommen von 1999 aufgenommen hat, wird die Schweiz in diesem Bereich zu einem normalen Drittstaat. Dann m\u00fcssen wom\u00f6glich nicht nur die neuen Medtech-Produkte aus der Schweiz in der […]<\/p>\n","protected":false},"author":35,"featured_media":3873,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[3303],"tags":[4234,4020,4232,4233],"class_list":["post-3872","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qualitaetsmanagement","tag-blockade","tag-med-tech","tag-rahmenabkommen","tag-schweiz-eu"],"acf":[],"yoast_head":"\nMedTech-Produkte: Schweizer Branche unter Druck - MQ Management und Qualit\u00e4t<\/title>\n<meta name=\"description\" content=\"Ab dem 26. 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