The EN ISO 15223-1: 2021 standard introduces the indication "MD", i.e. graphic information that a given product is a medical device. New symbols were also introduced to identify the economic operators - the distributor and the importer. The UDI code symbol, or the symbol informing that the product has been repackaged are as well functional. Additionally, there are new symbols indicates the sterile barrier system.
Furthermore, new graphics were added informing that the product contains:
- as an integral part, a substance that, when used alone, could be considered a medicinal product;
biological material of human origin,
biological material of animal origin,
harmful substances (carcinogenic, mutagenic or reprotoxic or endocrine disrupting substances),
human blood or plasma derivatives.
A significant change introduced by the new regulation is the obligatory use of harmonized symbols.