EU to Amend General Safety and Performance Requirements on Medical Devices

June 6, 2014 - PRLog -- On 12 March 2014, the EU Parliament completed a final vote on a proposal for a regulation regarding medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (1). An important revision concerns the use of phthalates in medical devices.

EU Regulates the Use of Phthalates in Medical Devices

The proposed amendment requires the ban of substances that are classified or recognized as

1. Carcinogenic, Mutagenic or toxic to Reproduction 1A or 1B (CMR, in accordance with Regulation (EC) No 1272/2008), or

2. Endocrine Disruptors (EDCs)

In concentrations above 0.1% by mass of homogeneous material, contained within medical devices that come into contact with the human body. The regulation states that such substances would be phased out within 8 years, should safer alternatives become available.

Extended Safety Requirements for Pregnant or Nursing Women

If specific medical devices are meant for the treatment of children, pregnant or nursing women, phthalates, which are classified as CMR, should be banned as of 1 January 2020. The only exceptions are the cases when the manufacturer has the ability to prove that no other safer substances are available, in which case the device’s labeling and (or) packaging needs to clearly indicate the presence of substances that are classified CMRs 1A or 1B or as EDCs.

The proposed Regulation also covers devices that contain or consist of nanomaterials that can be released in the human body. In accordance with the amendments, manufacturers are required to incorporate evidence as part of the device’s technical documentation or instructions, which demonstrates that the use of nanomaterials is in compliance with safety and performance requirements and standards.

References:

(1) Report on the proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 (COM(2012)0542 – C7-0318/2012 – 2012/0266(COD)) (http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf)

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