Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 28 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.
An example of such local implementation of the Directive is present in Bulgaria. As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Bulgarian database. Non-Bulgarian manufacturers that are based in European Union are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.
In accordance with the Law on Medical Devices, adopted by the Bulgarian Parliament during its session on June 12, 2007, and as promulgated in the Bulgarian State Gazette No. 46, some categories of medical devices must be registered with the Bulgarian Drug Agency (BDA). This registration is mandatory for medical devices that enter the EU internal market through, or if they are being manufactured in, the territory of Bulgaria.
The categories of medical devices that are affected by this obligatory registration are:
- Class I Medical Devices;
- Class Is and Class Im Medical Devices;
- Custom-made Medical Devices;
- Systems and procedure packs;
- Systems and procedure packs subjected to sterilization before use;
- Medical Devices subjected to sterilization before use;
- In Vitro Diagnostic Devices
The manufacturers of Medical Devices that are classes IIa IIb and III, and established outside Bulgaria, are exempted from this requirement.
Obelis, as a professional European Authorized Representative, can perform the registration procedure on behalf of Non-EU manufacturers. A registration application form is provided by BDA and the file is submitted as a hard copy via post or courier.
Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:
1.By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Bulgaria;
2.If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Bulgaria for a second (third, fourth, etc.) time;
3.Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.
1.For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
2.The manufacturer should register their medical devices with the Bulgarian database through his appointed Authorized Representative
Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Greece, Latvia and Croatia) and strengthen the need for a professional European Authorized Representative present at any time.