Updates to the Manual on borderline and classification

Written By Elisabethann Wright

The Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 has recently been updated. The revised Manual includes details concerning the classification of a number of products including:‍‍ ‍

  • Nasal spray with antibodies for COVID-19 is not a medical device

  • Saline solutions for nasal irrigation this device should be in Class IIa according to the third indent of Rule 21

  • Syringe containing glass beads Rule 3, first paragraph, is to be classified in Class IIb

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Elisabethann Wright
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