(17)As regards the use of ethylene oxide for the sterilisation of ‘combination products’, which contain elements specified in both Regulation (EU) 2017/745 and the Union legislation on medicinal products, Article 1(8) and (9) of Regulation (EU) 2017/745 set out the circumstances in which a product that combines a medical device and a medicinal product falls within the scope of Regulation (EU) 2017/745 or within the scope of the Union legislation on medicinal products.
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