The matter concerning production and/or the trade with medical devices, apart from attracting everyone’s wider interest, also reveals several peculiarities regarding the legal regimes, under which these devices should be brought.
In this article we will focus on the concept of a medical device: the categories of medical devices, as well as those groups of products that remain outside the scope of the regulatory framework regulating the market of medical devices.
The main questions concerning the terms and procedure for market release and/ or putting into service of medical devices; the obligations of the manufacturer; the terms and procedure for the designation and the supervision of notified bodies; the terms and procedure for trade in medical devices, etc., are regulated at the national level by the Medical Devices Act (MDA) and the by-laws on its implementation. The relevant Acts of European legislation also apply, among which of particular importance are Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5th 2017 on medical devices and Regulation (EU) 2020/561 of the European Parliament and of the Council of April 23rd 2020 amending Regulation (EU) 2017/745 on medical devices, with respect to the dates of application on some of its provisions.
The main purpose of the MDA, is to ensure market release and/or putting into service of medical devices that do not threaten the life and health of patients, of healthcare specialists or of third parties, as well as to ensure the implementation in the Bulgarian legislation of the relevant EU regulations and directives.
All products that fall under the categories of medical devices according to the Medical Devices Act follow strict regulations of the so-called ‘Market Release’; conducting clinical trials; procedure for trade and etc.
Therefore, it is essential before starting to trade and/or manufacture certain products, to determine the specific category in which they belong to, in order to estimate the legal regime that the trade and/or manufacture of these products would follow.
Medical Device Concepts
A definition of “medical device” is given on par.21 in the additional provisions of MDA.
Given that the provided definition in the law is significantly complicated, it suffices for this article to point out that a medical device may be an instrument, material, apparatus, or even software that is intended by the manufacturer to be applied on people for one of the following purposes:
- diagnosis, prevention, monitoring, treatment or alleviation of disease; for an injury or handicap;
- investigation, replacement or correction of an anatomical part or of a physiological process;
- birth control.
Categories of medical devices
Depending on the purpose intended by the manufacturer, medical devices are distinguished by law into three main categories:
- in vitro diagnostic medical devices. The devices within this category, based on the potential risk associated with them, shall be grouped in List A, List B, and devices for self-testing and other groups, as defined in the relevant Ordinances on the implementation of the MDA, in accordance with the rules of Art. 18 of the law;
- Active implantable medical devices.
- Medical devices other than the listed above two types. Devices of this category, depending on the potential risk associated with them are divided into classes I; IIa; IIb; and III in accordance with the classification rules defined in the relevant Regulations on the implementation of the MDA.
The different categories of medical devices differ in the requirements relevant to their registration, clinical trials, marketing control and should be carefully considered.
Non-medical products to which MDA applies
It is important to note that the requirements of the MDA, also apply to the categories of devices that are not medical. The ingredients of the product and its purpose are decisive in this assessment.
Among them are:
- accessories to medical devices;
- devices that incorporate, as an integral part, a substance which, if used separately, may be defined as a medicinal product under the Medicinal Products in Human Medicine Act and whose action on the body is ancillary to the main purpose of the device;
- devices by means of which medical products are administered.
Products excluded from the scope of the MDA
Just as it equates certain products to medical devices, MDA on the other hand, excludes from its cope certain, explicitly listed categories of products. The rules of other laws, bylaws and Acts of European legislation apply to them. An important feature in distinguishing them is their primary purpose or component.
Thus, for some of them the stricter rules of the Medicinal Products in Human Medicine Act apply and for others, such as cosmetic products, the lighter regulation of the Health Act applies.
Among the most important items excluded from the scope of the MDA, are:
- medical products under the Medicinal Products in Human Medicine Act. The evaluation whether a certain product falls within the scope of the Medical devices Act, or within the scope of the Medicinal Products in Human Medicine Act shall be made based on the main purpose of the product;
- medical devices that are an integral part of medicinal products and are intended by the manufacturer for single use only in this form;
- cosmetic products under the Health Act;