The European Commission issued a proposal on September 26, 2012 to propose amendments to existing medical device regulations. The European Parliament will first read the proposal and vote on October 23, 2013.

The European Commission is likely to ask for tightening when voting on the proposed measures for the regulation of chemical substances used in medical devices. Recently, members of Parliament and several health and environmental groups have expressed concern about the harmful chemical content of medical devices, particularly carcinogenic, mutagenic and reproductive toxic substances (CMR substances), and chemicals (EDC substances) that may interfere with the hormonal system. Future regulations should be more strictly regulated.

The French manufacturer Poly Implant Prothèse once provided problematic breast implants, affecting more than 400,000 European women, prompting the European Commission to propose the above proposal and recommend amendments to the current EU medical device legislation.

Mainland China and Hong Kong export a variety of medical devices to the EU, including heartbeats, sphygmomanometers, electronic thermometers, as well as syrup tapes and plastic syringes. Contact lenses, pregnancy tests bars, dental supplies and even X-ray machines are in line with the definition of medical devices.

Recently, some health and environmental groups, together with several Members, urged the EU to strengthen the control of medical devices, especially the harmful chemicals in medical devices. It is recommended that if adopted, certain substances will be banned and the production regulations for such products will be more stringent.

Two types of hazardous chemicals, CMR and EDC, are said to be widely used today in medical devices. These health and environmental groups argue that CMR and EDC substances in all medical devices should be banned unless there are no safer alternatives.

CMR materials include some phthalates such as di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) And butyl phthalate (BBP), these phthalates are commonly used in plastics to increase plastic elasticity and toughness. CMR materials also include certain metals such as cadmium, cobalt and chromium. EDC substances can be found in bisphenol A (BPA), and medical devices such as hoses and catheters may contain bisphenol A.

Toys, food packaging, hoses, raincoats, and cosmetics such as nail polish, hairspray, and shampoo may all contain phthalates. Because phthalates can interfere with the endocrine system, Europe has banned the use of children's toys. Phthalates have been regulated by the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations, but Danish Health Minister Astrid Krag hopes that future medical device regulations will also ban phthalic acid salt.

Health and environmental protection groups and Members have stated in their joint proposal that a more stringent pre-market approval process and post-market surveillance measures should be established for medical devices. It is considered that there is an urgent need to review the application for European Conformity Assessment (ie CE Marking). program.

Dagmar Roth-Behrendt, a member of Parliament from Germany, proposes a unified listing for Class III appliances that pose the greatest risk to patients, such as pacemakers and hip implants. Pre-audit system.

The bill has the opportunity to vote in the coming months and adopt it at the EU level. If the bill is passed, EU member states will have to implement it and the transition period will be three years.

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