In Bulgaria, the institution that regulates medical devices is the Bulgarian Drug Agency (BDA). On June 12, 2007 the Bulgarian Parliament created the Law on Medical Devices, which is the policy that is currently used to govern the registration of medical devices through the BDA. As Bulgaria is a part of the European Union, many of its device regulations abide by the EU Medical Device Regulations (EU MDR). More information on EU MDR and its labeling requirements can be found here.
In Bulgaria, general medical devices (not including IVDs or custom-made devices) are categorized into the following classes based on their posed risk to the human body: Class I, Class IIa, Class IIb, and Class III, with each class posing a higher risk than the one before it. Medical devices that are Class IIa, IIb, or III, and are manufactured outside of Bulgaria, are exempt from the requirement of having to be registered through the BDA.
If the manufacturer of the device does not have a tangible presence within Bulgaria or the European Economic Area, a European Representative must be appointed to oversee the registration of the device. All devices, except those that are custom-made, that bear a CE marking, abide by all acts under the Law, and pass conformity assessments conducted by the BDA shall be placed on the market.
All manufacturers must also provide technical documentation, which must be kept on hand by them or their European Representative for at least five years in case of inspection.
Registration Application
An application for registration must be submitted to the Executive Director of BDA. The dossier should include the following information:
- Valid entry certificate in the commercial register
- Information relating to the reagents, reagent products, and calibration and control materials (i.e. common technological and/or analytical characteristics)
- Instruction for use (in Bulgarian)
- Document for paid fee in the amount fixed by the tariff
- Some devices may require name, type, and model of the device; analytical and diagnostic features (if applicable); and performance evaluation results.
Clinical Investigations
The clinical investigation procedure must be performed in the following order:
- Confirm that, under normal conditions of use, the device performs one or more of its functions, which have been determined by the manufacturer
- Identify adverse side effects under normal conditions of use of the device
- Assess to what extent the identified adverse side effects are within the acceptable risk assessed in comparison to the benefit of the intended purpose of use of the device
More information on the technicalities and rules regarding clinical investigations can be found under Chapter 3, Section 1 of the Law.
After abiding by all requirements, an authorized Notified Body will issue a registration certificate that holds validity for five years. Once this information is passed on to the BDA for validation, the device can be marketed Bulgaria.
IVDs and Custom-made Devices
More information about IVDs and custom-made devices can be found under Section IV and Section III of the Law, respectively.These two types of devices have registration processes that are different from general medical devices.
