Withdrawal of EU medtech symbols standard leaves regulatory gap

02/6/2013 | Clinica (subscription required)

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."

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