http___www.instrumentaria.hr_news__1.xml
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EU: Update to harmonised standards for directives The EU has used implementing decisions to update the lists of harmonised standards relating to Directives 93/42/EEC (medical devices), 90/385/EEC (active implants) and 98/79/EC (in-vitro diagnostics). For medical devices, four articles and two annexes have been added to the implementing decision. Article 1 stipulates that the standards in Annex I replace the previous harmonised standards. Article 2 stipulates that the replaced standards listed in Annex II may still be used until 30th September 2021. In Article 3, the implementing decision makes specific reference to the fact that the harmonised standards for Directive 93/42/EEC are not harmonised for the upcoming EU Regulation on Medical Devices (EU) 2017/745 (MDR): "The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745." Article 4 restricts the applicability of the decision up to 26th May 2024, the day on which the expanded transitional regulations for legacy products in accordance with Article 120 of the MDR will expire.
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Kako bi se osigurala kontinuirana usklađenost sa direktivom vijeća 93/42/EEC o medicinskim proizvodima, Europska Komisija je 24.09.2013 god stavila novi regulatorni zahtjev pred prijavljena tijela i proizvođače medicinskih proizvoda klase rizika III o provedbi nenajavljenih audita. Slijedom novog regulatornog zahtjeva, dana 22.02.2017 god prijavljeno tijelo SGS UK je izvršilo nenajavljeni audit u Instrumentariji. Prijevaljeno tijelo je utvrdilo kako su svi procesi u skladu sa zahtjevima direktive 93/42/EEC te da je sustav upravljanja u potpunosti u skladu sa regulatornim zahtjevima ISO [...]