General Product Safety Directive -- MEDICA - World Forum for Medicine


Obelis European Authorized Representative Center (O.E.A.R.C.)

General Product Safety Directive

General Product Safety Directive 2001/95/EC

The Directive 2001/95/EC, known as the General Product Safety Directive (GPSD) is now in force as of January 15, 2004. The Directive, designed as a European Union-wide effort to improve consumer health, safety, and availability of quality products.

Originally created December 3, 2001, the Directive sets safety requirements for consumer products ranging from sports equipment, household products, to medical device equipment. The Directive empowers member states to establish requirements depending the risk and hazard posed by individual products either being introduced within the European Union or already in circulation.

Similarly, the Directive empowers Member States to take any necessary action to remove any "serious risk requiring rapid action". These actions include, but are not limited to:

an entire ban and recall where a "serious risk requiring rapid action" is identified information regarding such actions may be available to the general public ban on exporting the product from the EU to third countries.

Work is still being done by the EU on establishing a list of potentially dangerous products of European Union-wide concern, as well as establishing within the Member States means of monitoring and testing these products. The GPSD is a "per-product" format Directive, meaning that requirements and action required varies across products and is evaluated on a product to product basis.

How does this Directive effect a Non-European Manufacturer?

Manufacturers, as well as distributors, are now legally obligated to ensure that their products reside within the bounds of the new General Product Safety Requirements and will be held responsible for not doing so. This includes informing the authorities about potentially dangerous supplies of your products, and can result in tracing your product to remove it from the market.

Obelis European Authorized Representative Center (O.E.A.R.C.)is comprised of a team of regulatory experts who maintain the latest communication and changes regarding the GPSD and other EU Directives that directly apply to your product. We maintain continual communication with the Competent Authorities and can keep you immediately informed of any information applicable to your product(s). We can assist you in introducing or maintaining your products' circulation within the EU and guide you through the regulatory maze of product safety and requirements.

Obelis (O.E.A.R.C.) is backed by 16 years, giving Commercial, Regulatory, Administration, and Market development services. Contact us today for specifics pertaining to your products.

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