The new Medical Devices Act (Zakon o medicinskim sredstvima, “Official Gazette of RS“, no. 105/2017), which had entered into force already on 1 December 2017, became applicable on 1 December 2018. The adoption of this legislation marks the beginning of distinct legal treatment of medical devices, separate from the treatment of medicinal products which remain regulated by the old Medicines and Medical Devices Act (Zakon o lekovima i medicinskim sredstvima “Official Gazette of RS“, no. 30/2010, 107/2012, 113/2017, and 105/2017) ( “Medicines Act”).
The Medical Devices Act regulates medical devices for human use (including devices used for in vitro diagnosis and active implantable medical devices) and aligns quality and technical requirements for medical devices with those set out in the EU Medical Devices Directives (Active Implantable Medical Devices Directive 90/385/EEC, Medical Devices Directive 93/42/EEC, and In Vitro Diagnostic Medical Devices Directive 98/79/EC) and the MEDDEV instruments.
The objective behind the adoption of a separate legislation on medical devices was to prevent the placement onto the Serbian market of low-quality or counterfeited medical devices. The legislation therefore establishes a system for conformity assessment of medical devices before their placement on the market and for the monitoring of medical devices already placed on the market. The legislation introduces a national conformity assessment mark in addition to the EU CE marking, to foster faster and cheaper conformity assessment procedures for national manufacturers. Conformity assessment of medical devices will be performed by specialized conformity assessment bodies. The Agency remains competent for the Registry of Medical Devices, for recognition of foreign conformity documents and conformity marks, and for conformity assessment and technical assessment of medical devices with the requirements set out in the monograph of the national pharmacopoeia, applicable European pharmacopoeia or international pharmacopoeia.
Improvements were also introduced to the process of approval of clinical trials of medical devices. The deadline for the response by the Agency for Medicines and Medical Devices to a request to conduct a clinical trial is reduced from 60 to 40 days from the receipt of the request, while the deadline for the decision of the Ethical Committee is reduced from 60 to 30 days.
The Serbian Chamber of Commerce is charged with the statutory duty to maintain the following registries related to medical devices: (i) Registry of Wholesalers, (ii) Registry of Importers; and (iii) Registry of Specialized Stores.
Registration of medical device remains an administrative requirement but is no longer a prerequisite to its placement on the market or putting in use, provided a conformity assessment is obtained and an application for registration to the Agency is made. Registration is valid for 60 days after the expiry of the conformity document, and for medical devices of the lowest risk (class I) and in vitro medical devices, for which the declaration of conformity is issued by the manufacturer for a period of five years. Medical devices may remain on the market for a maximum of 90 days following the expiry of the registration. If a request for the extension of the registration is not filed within those 90 days, the medical device may not be imported.
The Ministry of Health issues a manufacturing licence for class I medical device (other than the Is and Im class), other in vitro diagnostic medical devices, medical devices not subject to conformity assessment or sign of conformity, custom-made medical device for a particular patient, medical devices for clinical trials, as well as for system or kit of medical devices. Manufacturers who obtain a manufacturing licence from the Ministry may distribute medical devices from their own production programme without a wholesale license, while Serbian manufacturers who do not require a manufacturing licence must obtain a wholesale licence for distribution of their medical devices.
The new Medical Devices Act dispenses with the obligation to request approval on promotional materials for medical devices from the Agency for Medicines and Medical Devices. The Agency may perform control of promotional materials for medical devices already placed on the market on a case-by-case basis on the proposal of the Ministry, when the competent inspectorate assesses that there is a risk.