THE NORMATIVE REGULATION OF MEDICAL DEVICES – A GUARANTOR FOR THE PROTECTION OF PATIENTS’ RIGHTS AS USERS OF HEALTH SERVICES IN THE REPUBLIC OF BULGARIA
Authors: Chakaldziyan Mikael 
Published: March 2020

Health is envisaged as a right of the citizens both in the Constitution of the Republic of Bulgaria and in the Treaty on the Functioning of the European Union. Healthcare is subject to regulation by a number of secondary European legislation acts as well as by acts of our domestic legislation. The overall state policy on health care provision and development constitutes a complex set of diverse activities. Its quality is largely the result of strict and good-faith implementation of the normative regulations, addressing both public authorities and individuals. Exercising preventive medical procedures, adequate diagnosis and conducting successful treatment are undoubtedly essential parts of healthcare. This essential part is implemented by healthcare professionals with specific qualifications and by using medicinal products that contribute to achieving positive results in each patient's health in every individual case. In turn, medical equipment such as apparatus, instruments, materials and other supplies, plays an increasingly important and crucial role in the overall process of the actual implementation of medical assistance. Today, secondary European legislation determines medical equipment as a medical device and defines it. The continued development of science in the field of medicine, as well as in other fields, is an important factor in achieving ever greater opportunities for medical care and determines the significant place of medical devices in the provision of healthcare to a particular patient. Using them is often the only way to correctly diagnose a patient, though the cases where the medicinal product itself comes into contact with the patient's body through a medical device are also not isolated. The presence of the appropriate type of medical device and its corresponding level of quality are essential prerequisites for proper diagnosis and conducting a precise treatment procedure to achieve the optimal end effect. To ensure a positive result in the patient's health, medical devices must be safe and meet a number of quality requirements. The safety and quality of medical devices are a prerequisite for the actual realization of the right to healthcare for citizens. This report examines some administrative-juridical remedies for exercising control over medical devices, as well as certain obligations that individuals should carry out when performing activities related to medical devices. Bearing in mind the actual object of protection in medical law - the patient, and that one of the principles of consumer law is to protect the life and health of the consumer as an individual, it is concluded that medical and consumer law have the same object of protection and that is every individual. The report makes a comparative analysis of the administrative-juridical measures taken by the Medicines Executive Agency and by the Consumer Protection Commission. It also compares some of the obligations that private law entities need to observe in medical law in respect to medical devices and those of private parties in consumer law regarding goods.