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HRPRES2020: Meeting of the Competent Authorities for Medical Devices (CAMD) hosted by HALMED


As part of the Croatian Presidency of the Council of the European Union, on 4 and 5 June 2020 Croatian Agency for Medicinal Products and Medical Devices (HALMED) hosted the Competent Authorities for Medical Devices (CAMD) meeting. This marks the most important strategic meeting in the field of medical devices organised by HALMED during HRPRES2020. It is, at the same time, the first CAMD meeting held virtually, due to the COVID-19 pandemic circumstances.

The meeting was chaired by Suzana Oštarčević, MPharm, Head of Division for Safe Use of Medicinal Products and Medical Devices of HALMED, and vice chair of CAMD Executive Group (CEG), who welcomed participants and set the meeting in the context of current events, while emphasising the importance of maintaining continuity of CAMD’s activities.

Nelli Karhu, PhD, Senior Inspector of the Finnish Medicines Agency (FIMEA), gave an overview of the outcomes of the previous meeting. In line with the host role, HALMED’s experts presented the part of the medical devices system under HALMED’s competence. Krunoslav Kranjčec, M.Med.Biochem., Head of Department for Medical Devices, presented the registration system for manufacturers, authorised representatives, importers and wholesale distributors and retailers of medical devices. Moreover, Antonela Šimunović, M. Sc.biotech. in med., Senior Associate in the Department for Medical Devices, presented the upgrade of the OPeN platform (online platform for electronic incident reporting) which should, apart from the reporting of side effects, facilitate the reporting of incidents related to medical devices in Croatia.

On behalf of the CEG, Dr Helena Dzojic, MD, PhD, Head of Department of Medical Devices of the Swedish Medical Products Agency (Läkemedelsverket) reported on the activities of the Executive Group, while representatives of the European Commission - Anna Eva Ampelas LL.M., Head of Department for Medical Devices of DG SANTE and her deputy, Erik Hansson, LL.M., provided update on the preparations for the implementation of Regulation (EU) 2017/745 on medical devices, as well as on all measures and activities that were carried out in the context of the COVID-19 pandemic.

Thomas Wejs Møller, LL.M., Head of Department for Medical Devices of the Danish Medicines Agency (Lægemiddelstyrelsen) presented in detail the priorities of implementation process of Regulation (EU) 2017/745, emphasising the main areas where quick progress is expected, in terms of medical devices related to patient safety and public health, timely access to safe medical technologies, transparency, information and communication, as well as management, coordination and uniformity in the regulatory approach. In line with the decision by the majority of the plenum, Thomas Wejs Møller was appointed as the new chair of the CEG, whereas the re-election of other CEG members was postponed until the next face-to-face meeting.

In the remaining part of the meeting, representatives of the national competent authorities exchanged information on communication with industry representatives and other stakeholders, and on the occurring challenges in their daily work during the COVID-19 pandemic. Within the stated period, a priority was given to certain groups of medical devices, including masks and other protective equipment, in vitro diagnostic medical devices, mechanical ventilators and other essential products, as well as their availability on the market.

Approximately 70 CAMD members, consisting of the EU national competent authorities’ representatives, representatives of the European Commission and representatives of Serbia and Turkey, attended the meeting.

CAMD gathers regularly during each Presidency in order to make strategic and operational decisions for harmonising medical devices regulatory system, strengthen cooperation and mutual coordination on the common internal market.