NON-EUROPEAN IN-VITRO DIAGNOSTIC MEDICAL MANUFACTURER
The IVDD 98/79/EC In-Vitro Diagnostic Medical Devices Directive published on October 7, 1998 requires Non-European IVDD Manufacturers to appoint a European Authorized Representative to sell their product in Europe.
(IVDD 98/79/EC Article 9.7) Obelis (O.E.A.R.C.) is the foremost Authorized Representative for your In-Vitro Diagnostic Devices.
Published in October 7, 1998, the In-Vitro Diagnostic Medical Manufacturer Directive is separate from the Medical Device Directive with its own separate set of requirements for companies wishing to sell medical devices within the EU must meet the requirements under the directive. This directive does not specifically list out the products that fall under it. Rather, the responsibility is placed on the manufacturer to determine what directives apply to their product. In beginning the process of selling your product, an Authorized European Representative can help you make the determination of what directives apply to your product or products and streamline the process to get your product on the market faster.
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
• Determine the number of required translations and for what documents
• Selection of a Notified Body for certification (if required)
• EC Declaration of Conformity
How does the In-Vitro Diagnostic Medical device 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 IVDD 98/79/EC 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.
Contact us for our services, your questions, and our assistance.