Since there has been an ongoing process of harmonising the documentation for the registration of medical devices in the European Union due to the transition from EU directives (93/42 EC, 90/385/EEC and 98/79 EEC) to EU Regulations (MDR 2017/745 and IVDR 2017/746), the manufacturers of medical devices have been submitting to the notified bodies applications for recertification of EC certificates issued in line with previously valid legislation with the aim of issuance of new certificates in accordance with new regulations.
Consequently, a large number of applications for extension of the Decision on the registration of medical devices has been submitted to the Institute at the same time which may lead to the situation that decisions on the registration expire, but a decision on the extension of the registration, i.e. a new decision on the registration of medical device has not been issued yet.
Namely, in accordance with Article 41 of the Law on Medical Devices (“Official Gazette of Montenegro”, No. 24/19), the Institute for Medicines and Medical Devices shall issue a decision on the registration of a medical device the validity period of which may not be longer than 60 days from the expiry date of a document on conformity (EC certificate), while medical devices may be present on the market for a maximum of 90 days from the expiry date of the decision on the registration of the medical device.
Based on the above mentioned, the validity period of the decision on the registration was 25 July 2024, whereby medical devices could be present of the market for a maximum of 90 days from the expiry date of the decision on the registration of the medical device, i.e. until 25 October 2024, about which you have been already informed.
As the marketing of medical devices in Montenegro is carried out on the grounds of a decision issued by the Institute and especially bearing in mind that the application of the provisions of the Law on Medical Devices will affect regular supply of the Montenegrin market and health institutions with the necessary medical devices by foreign manufacturers, the Institute has informed the Customs Administration that until the this issue is resolved, the import of medical devices will be carried out on the grounds of the existing decision and an evidence that an application for the extension of the registration or for the registration of the same medical device has been submitted.
In accordance with obtained approval wholesalers and authorized representatives of manufacturers may submit expired decisions on the registration/extension of the registration of medical devices in tender procedures (procedures of public procurement), at customs terminals when importing medical devices, as well as for the purposes of approving manufacturer/supplier orders after the expiration of the specified deadline, i.e. until the issuance of a new decision on the registration/extension of the registration of the medical device, and until the end of the current year at the latest.
