NON-EUROPEAN MEDICAL DEVICES MANUFACTURERS
The MDD 93/42/EEC Medical Device Directive, mandatory since June 14,1998 requires Non-European Medical Device Manufacturers to appoint a European Authorized Representative to sell their product in Europe .(MDD 93/42 Article 14 ) Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your Medical Devices. The European Union Medical Technology industry is a market of about 55,2 € billion. Under the Medical Device Directive there are about 8,000 different types of product. Obelis wants to help you take advantage of the opportunity to enter such a large and lucrative market while navigating the difficult waters of MDD regulation.
Originally created July 12, 1993 and mandatory since June 14, 1998, the Directive requires that companies wishing to sell medical devices within the EU must meet the requirements under the directive. The regulations under this mandate can vary from member country to member country concerning translation of key documents to other regulatory laws specific to that region. These additions supplement the set of harmonized standards put in place by the European Commission. These harmonized standards serve to free the flow of goods from one market to another within the EU Medical Device industry.
Requirements under this mandate include, but are not limited to:
• Establishing an Authorized European Representative if manufacturer is located outside the EU
• Choosing and follow the appropriate assessment module
• Providing a technical file
• Selection of a Notified Body for certification (if required)
• EC Declaration of Conformity
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 Medical Device Directives 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. The European market has the potential to be a very lucrative venue to sell your products; however, ignoring or failing to meet the regulations such as the Medical Device Directives can prevent the free-flow of your product or worse, remove your product 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 MDD 93/42/EEC 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 18 years, giving Commercial, Regulatory, Administration, and Market development services. Contact us today for specifics pertaining to your products.