As of March 21, 2010 all medical devices distributed in the EU must abide by Directive 2007/47/EC which is amending the Medical Devices Directive (MDD) 93/42/EEC. After this date, manufacturers who CE mark their devices under directive 93/42/EEC must also comply with 2007/47/EC.
Article 33 of the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation requires manufacturers and suppliers to submit information on certain chemicals to their customers and the end consumers. A new revision introduces a screening methodology for the identification of substances relevant for the Electrical & Electronic industry.
Electrical product certifications are complex endeavours, but when handled by experts they optimise processes and can considerably shorten times to market. For all country-specific, product-specific or job-specific qualification requirements SGS can support manufacturers and retailers through its extensive global portfolio of services.
Dozens of criteria and regulations must be taken into consideration when placing electrical and electronic products on the market of the European Union. Retailers and importers rely on independent testing, certification and verification companies, such as SGS to ensure their products will succeed.
SGS offers Hazardous Substances Testing Services (HSTS), which determines and reports the level of HS in electric and electronic products in accordance with the latest IEC standards.