Bulgaria and Romania Join the European Union
On January 1, 2007, Bulgaria and Romania were accessed to the European Union. With these additions, the EU now has a total of 27 member countries and contains over 500 million people. Medical Device Manufacturers shipping products into Bulgaria and Romania will now be required to comply with the EU Directives for Medical Devices (MDD), In-Vitro Diagnostics (IVDD), and Active Implantable Medical Devices (AIMDD).
The purpose of the European Directives is to facilitate a single market with minimal technical barriers to trade. The Device Directives provide harmonizing rules on the safety, quality and performance, and sets out a common regulatory environment for medical devices across Europe under which IVDs must meet certain essential requirements. Government agencies known as Competent Authorities are responsible to insure the requirements of the Directives are being followed. Products must be registered with a Competent Authority before they can be sold in the EU. The UK Competent Authority is the Medicines and Healthcare products Regulatory Agency (MHRA).
Manufacturers of medium and high risk devices are required to submit a technical file and make available their quality management system available for audit by an independent third party certification body known as a Notified Body. Compliance with the relevant medical directive is verified by the Notified Body through a process of sampling the quality management system and an assessment of the technical file to ensure all relevant essential requirements have been addressed by the manufacturer.
Products manufactured outside of the EU must have representation within a member state. This is the designated Authorized Representative who is legally responsible for registering the product with a Competent Authority for compliance and subsequent post-marketing surveillance and vigilance for the product.
The CE Marking is the outward sign that the manufacturer has declared that its device(s) meets all relevant essential requirements of the relevant European directive and is therefore permitted free market access to all EU countries. For IVDs and Medical Devices, the CE Marking means that the device meets a defined set of minimum safety requirements and is manufactured under a quality system capable of supporting the ongoing manufacturing and design of safe and effective medical devices. The number beneath the CE mark identifies the Notified Body that has performed the assessment. For example, UL's Notified Body number is 0843.
Companies exporting to the EU must comply with the national differences for each of the member countries in which they will market and sell their products. Since Bulgaria and Romania have only recently joined the EU, the official EU language has not been annuonced. Medical device manufacturers looking to market and sell products to these countries may need additional translation requirements and should be aware of any other national differences prior to market entry.
References:
http://www.mhra.gov.uk -- “Guidance on the EC Medical Devices Directives.”
http://europa.eu/