Monday, 12 May 2014

EU Amendments to Hazardous Substances in Medical Devices

On 12 March 2014, the EU Parliament completed a final vote on a proposal for a regulation regarding the use of phthalates in medical devices.  

The proposal will amend Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. It requires the ban of substances that are classified or recognised as:
  • Carcinogenic, Mutagenic or toxic to Reproduction 1A or 1B (CMR, in accordance with Regulation (EC) No 1272/2008), or 
  • Endocrine Disruptors (EDCs) 
Photo Courtesy of SGS
The revision only applies to substances of 0.1% concentration and above and which are contained within medical devices that come into contact with the human body. Should safer alternatives come available, then substances will be phased out within 8 years. 

If the medical device in question is used in the treatment of children, pregnant or nursing women, phthalates should be banned as of 1st January 2020. The only exception is when no safer alternative substance is available, in which case, the device's packaging and labelling will then need to indicate this. 

To read the article in full, please visit the SGS website

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