The Medical Equipment Industry Faces Tough Changes To Comply With REACH Legislation, Europe

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 17 Nov 2008 - 5:00 PST

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New European limitations for restricted substances in medical devices are coming into force under the new REACH legislation.

For the first time, Medical Equipment will be included under the European Union's RoHS legislation, the requirement to disclose Substances of Very High Concern (SVHC), and the inclusion of medical products in the Electronic Information Products (EIP) list for China RoHS.

These changes will force medical device and equipment companies to convert all products to become restricted substance (RoHS, SVHC) compliant.

Intertek, the leading provider of quality and safety solutions, has recently launched new training and implementation programs specifically to help the Medical Equipment Industry meet a number of new restricted substances requirement and comply and understand the upcoming REACH legislation.

Education will be offered both on-line through Webinars and through on-site training. The training and implementation modules will include overviews of the Global RoHS Directives and the REACH Directives, and Engineering training to create restricted substance compliance files on products.

Tom Rainone, General Manager of Intertek Health & Environmental Services 'CMS unit, notes that, "Intertek-CMS has helped guide the Electrical and Electronics Industry through restricted substances compliance in recent years. As the medical equipment industry now faces a number of new changes, we are bringing our implementation knowledge to help them address the required transition without interrupting their normal design and business processes."

REACH compliance affects all manufacturers, importers, distributors or users of chemical substances or products in the EU, across industries as far reaching as electrical and electronics, aerospace and automotive, life science and medical, building products, retail products, chemicals, textiles, and toys.

For more information on Intertek's REACH services, including the accelerated pre-registration service, please visit the Intertek website at http://www.intertek.com.