Module 17 2024

03/12/2024

This directive applies to all packaging used to bring medical and IVD medical devices to market, including the retail pack, but also transit packaging such as outer cartons, plus the likes of pallet straps, shrink wrap, etc. The directive restricts certain heavy metals from use: cadmium, lead, mercury, and hexavalent chromium Concentration is measured as a proportion of the weight of the packaging item itself, and not by weight in each homogeneous material as required by RoHS.

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Packaging and Packaging Waste Directive-94/62/EC

There are numerous country and regional differences

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Packaging needs to be considered early and based on comercialisation planning

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Cost implications

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Material qualifications challenges

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Often overlooked until there is an issue with import Hospitals are particularly inquisitive due the reporting responsibilities Manufactures also have reporting responsibilities based on what they receive from suppliers and put into the waste stream

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RESTRICTION OF HAZARDOUS SUBSTANCES (ROHS)

 DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS II)

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