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Is CE mark needed for US Saline bags when using in an EU clinical trial?



  • Ferenc
    04/06/2020 16:26
    There have been a recent shortage of saline bags globally and one of our suppliers offered bags with saline solution for infusion from the US for one of our EU studies. We are almost certain that CE marking is required for medical devices prior using the goods in the EU. But the product is actually not the bag “only” but the saline solution in the bag, together. In this case I interpret the product as a medicinal product and not a medical device. Is that right that in this case CE marking does not apply for the product? As it shall comply with the clinical trial directive in the EU prior being able to use in the study. Does the interpretation of the need for CE marking differ in the EU countries or it is the same no matter where we would like to import the goods?
  • GMP Committee response
    29/06/2020 14:07
    The CE marking requirements should be uniformly applied across the EU, UK and EEA countries. CE marking requirements do not apply to medicinal products, but administration sets are Class I medical devices. The sodium chloride solution in the bag (as its container-closure system) would be a medicinal product and as such does not need a CE mark. However, the pharmacopoeial monograph for sodium chloride for infusion is not formally harmonized across EU and US and, even if the product is the same, the labeling will differ, so this would be an unlicensed medicinal product in Europe. The rules for importation and use of unlicensed medicinal products do differ between European countries. We would not generally recommend use of unlicensed medicinal products in clinical trials unless they are an IMP subject to investigation, included in the IMPD/CTA and with an EU batch release site. However, given the current challenges to pharmaceutical supply chains arising from COVID-19, regulators are showing flexibility and allowing alternative sources. Requirements should be checked with the national regulator(s) relevant to the intended clinical sites. It would also be advisable to check with clinical sites for compatibility with their administration sets and to ensure that they are aware of the differences in labeling.
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