The removal of the harmonized symbols medtech standard in Europe, known as EN 980, has created a gap in the European regulatory standards framework. EN 980 was expected to be replaced by the global standard ISO 15223-1 of 2012; however, that standard hasn't been harmonized for application in Europe. An official said the regulatory vacuum "was unintentional and will be put right at the next harmonized standard listing publication."
Withdrawal of EU medtech symbols standard leaves regulatory gap
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