Clinical trials on medical devices from the Bulgarian perspective

Bulgaria

Technological advancements in the health sector undoubtedly play a key role in the improvement of the quality of care, life and health outcomes. With the significant surge in new medical devices around the globe, the questions of how they are released on the various markets, what the terms and procedure for their designation are, and what the potential professional liability resulting from clinical trials is, are becoming ever more relevant.

Currently, Bulgaria ranks 20th worldwide in terms of the number of clinical trials conducted, with a market value of USD 330 million. This translates into Bulgaria having a strong potential for Contract Research Organizations (CRO), with all the big players present in the country. Likewise, there is an active Bulgarian Association of Clinical Research (BACR) comprising over 135 members that advocates for high standards in clinical trials and conformity with Bulgarian and international norms.

Legal aspects

In the territory of Bulgaria, medical devices are heavily regulated by the Bulgarian Drug Agency (BDA). The BDA functions in compliance with the Medical Devices Act, which provides the legal framework for medical devices registration in Bulgaria. In addition, due to Bulgaria’s membership of the European Union, its devices regulations abide by the EU Medical Device Regulations.

Medical devices manufacturers need to file an application in standardized form with the BDA Executive Director no later than 14 days after releasing the medical device on the market. Clinical trials of medical devices must be carried out for the following purposes:

  • to confirm that under conditions of normal use, the device performs one or more of the functions defined by the manufacturer;
  • to identify the adverse side effects of the device under the conditions of normal use;
  • to evaluate whether the adverse side effects identified fall within acceptable risk, assessed against the benefits from the intended use of the device.

Following compliance with all conditions, the approved Notified Body will issue a registration certificate valid for five years. The medical device can be marketed in Bulgaria after this information is submitted to the BDA for validation. In addition, the BDA keeps a public register for all registered medical devices.

Professional liability in clinical trials with medical devices

Any individual or legal entity that performs a clinical trial activity with medical devices in the territory of Bulgaria is mandatorily obliged to take out professional liability insurance. The insured must be registered with recognized competence to exercise the respective profession or activity in the Republic of Bulgaria and the performed activity lie within the framework of such registration or legal capacity. The insurance indemnity under the insurance must include the amounts that the insured persons are obliged to pay by law and on the basis of claims of the participants in the clinical trial with a medical device or third parties as compensation for an insurance event coved by the insurance as well as the cost of settling the claims, made with the written consent of the insurer. The insurance indemnity cannot exceed the limit of liability stated in the insurance policy.

While the insurance contract is valid, the Insured must comply with all relevant legal provisions governing clinical trials with medical devices, adhere to the positive opinion of the Ethics Committee, and provide to the Committee all necessary documents and information so as to promote the rights, safety, and health of the participants in the trial.

For more information on the topic, call or email your regular CMS contact, or our local CMS expert, Antonia Kehayova, CMS Sofia.

Co-authored by Berdzh Draganov, Trainee Lawyer at CMS Sofia