In the period after 24 July 2024 the Institute for Medicines and Medical Devices shall give the approval to authorized representatives of manufacturers of medical devices to extend the validity of all expired decisions on registration/extension of registration of medical devices for a period of 90 days from the date of expiry of the decision.

In accordance with given approval wholesalers and authorized representatives of manufacturers may submit expired decisions on registration/extension of registration of medical devices in bidding processes (public procurement procedures), at customs terminals when importing medical devices, as well as for the purposes of approving orders of manufacturers/suppliers, within 90 days from the date of expiry of the decision on registration/extension of registration of medical devices.

Along with expired decision on registration/extension of registration, the authorized representative of the manufacturer shall submit a Confirmation of receipt of the application issued by the Institute for Medicines and Medical Devices, stating that the applicant is in the process of issuing a Decision on the extension of registration of a medical device.

According to the Law on medical devices (“Official Gazette of Montenegro”, No 24/19),  and with regards to Article 120 of the EU Regulation 2017/745/EU (with amendments No 2020/561/EU and 2023/607/EU) prescribing the transition time for the alignment of medical devices and taking into account the corresponding application of the opinion of the Ministry of health of Montenegro (No 1-040/23-4279/2 from 14 December 2023), the Institute for medicines and medical devices shall apply new requirements and manner of recognition of EC certificates – foreign certificates of conformity of medical devices as follows:

1. If the procedure for the alignment of medical devices with EU Regulation 2017/745 has been initiated by the submission of documentation by the manufacturer to the notified body, the procedure for recognizing the EC certificate is as follows:

If the Certificate of Conformity – EC certificate issued by the authorized body in accordance with the previously valid directives was valid on 26 May 2021 and has not been subsequently withdrawn, it will remain in force even after the expiry of the validity date provided on the certificate until the following dates:

31 December 2027 – for medical devices of risk class III, IIb which are implantable (with the exception of sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors), AIMD medical devices.

31 December 2028 – for medical devices of risk class IIb which are not included in the item a., IIa and I which are placed on the market in sterile condition or with a measuring function.

In order for medical devices to be placed on the market and put in use on the territory of Montenegro by December 2027 and 2028, the following requirements must be met:

• that they are still in compliance with the directives 90/385/EEC and 93/42/EEC;
• that there are no significant modifications regarding the design and purpose of the medical device;
• that the medical device does not pose an unacceptable risk to health or safety of patients, users or other persons or to other aspects of health care;
• that the manufacturer has established a quality management system in accordance with Article 10(9) of the MDR no later than 26 May 2024;
• that the manufacturer has submitted official application to the authorized conformity assessment body no later than 26May 2024;
• that the designated body and the manufacturer have signed a written agreement in accordance with Annex VII of the MDR, no later than 26 September 2024;

2. If the procedure for the alignment of medical devices with Regulation 2017/745 has not been initiated by the submission of documentation by the manufacturer to the notified body, the procedure for recognizing the EC certificate is as follows:

– If the EC certificate was issued by an authorized body in accordance with the previously valid directives 90/385/EEC and 93/42/EEC from 5 May 2017 and was valid on 26 May 2021 when the EU Regulation 2017/745 began to be applied, and which was not subsequently withdrawn and the manufacturer did not submit the official application to the authorized body for conformity assessment, i.e. the manufacturer and the authorized body did not sign a written agreement in accordance with Annex VII of the EU Regulation, the Institute will issue decisions on extension of registration of medical devices with a period of validity until 26 May 2024.

According to Article 41 of the Law on Medical Devices, the Institute issues a decision on registration of a medical device the validity period of which may not be longer than 60 days after the expiry of the validity of the Certificate of conformity, and accordingly 60 days were added to the above-mentioned deadline, 26 May 2024, as prescribed by the Law; it means that decisions on registration with a validity period until 24 July 2024 were issued for all medical devices for which the manufacturer did not submit the official application to the authorized body for conformity assessment, i.e. the manufacturer and the authorized body did not sign a written agreement in accordance with Annex VII of the EU Regulation.

According to the Law on medical devices wholesale of medical devices shall include procurement, storage and distribution, except for dispensing a medical device to an end user, i.e. the patient for his/her personal needs.

Article 41 paragraph 3 of the Law on medical devices prescribes that medical devices for which no application for registration extension has been submitted may be on the market for a maximum of 90 days from the expiry of the validity date of the Decision on the registration of the medical device.

Bearing in mind the above-mentioned and the fact that medical devices may be marketed on the territory of Montenegro 90 days after the expiration of the Decision on the registration, as well as the problems manufacturers face in the transition time, we reckon that the import of medical devices in the period after 24 July 2024, i.e. after the expiry of the Decision on the registration, may be performed on the basis of them until the expiry of the prescribed period of 90 days.

Please be informed that document Manner of submitting application and documentation for variations is now published on the CInMED website, along with an updated application form for notification/approval of a variation. Marketing authorization holders are asked to follow the published instructions and to use the updated application form when preparing and submitting documentation for variations.

Report on the results of spontaneous reporting of adverse reactions to medicines in 2023

Please be informed that the Report on the results of spontaneous reporting of adverse reactions to medicines in 2023 has been published on the portal of the Institute in the section Pharmacovigilance/Annual reports.

The published report contains the analysis of adverse reactions to medicines reports sent to the Institute for medicines and medical devices during 2023, a brief overview of the most important regulatory measures taken by CInMED during the previous year, as well as information on the educational activities conducted with the aim of the improvement of the pharmacovigilance system in Montenegro.

Compared to the previous year, in 2023 there was a significant increase in total number of submitted reports which is a result of greater involvement of healthcare professionals in the system of monitoring of the use of medicines. Bigger number of reported adverse reactions is primarily the result of the SMART Pharmacist – Therapy Management Process project, which was launched in September 2023 and organized by CInMED. Its goal was to educate and improve the competencies of pharmacists as the most accessible providers of health care, and the majority of adverse reactions to medicines reports received in 2023 were submitted by pharmacists who participated in the mentioned project. Majority of submitted reports related to medicines that act on the cardiovascular system, which is expected, considering that this group of medicines is the one most often used in Montenegro. When it comes to adverse reactions, majority of reported reactions related to disorders of the digestive system and reactions on the skin in the form of rashes and redness. On this occasion, CInMED would like to remind healthcare professionals and patients that during summer months it is necessary to pay special attention to the fact that many medicines (antibiotics, diuretics, pain relief medicines, retinoids…) can increase the skin’s sensitivity to UV rays and cause photosensitivity reactions. When prescribing and dispensing these medicines, patients should be warned to read the package leaflets of a medicine, as well as to take the necessary measures to protect the skin from UV rays, so as to prevent photosensitivity reactions.

CInMED would like to thank all healthcare professionals and patients that by reporting adverse reactions contribute to monitoring of the use of medicines in Montenegro.