Common regulation of medical devices in Europe and patient safety are the priorities
Svens Henkuzens, the Director of the State Agency of Medicines, and Daiga Lagzdiņa, the Head of the Medical Devices Evaluation Department, are participating in the meeting of Competent Authorities for Medical Devices in Dublin, Ireland, on 17th and 18th November 2015, thus, continuing the professional discussions started at the previous CAMD meeting in Riga in February 2015 regarding a common, improved regulation of medical devices, market surveillance of medical devices and other new issues in the field in Europe.1 Svens Henkuzens, the Director of the State Agency of Medicines: "The development of the field of medical devices is currently very dynamic, and the European Commission together with the competent authorities of the member states have to be ready to ensure an appropriate legal framework, as well as effective market surveillance mechanisms for the rapidly growing field, so that patients would be equally protected throughout the EU. These regular discussions among experts from competent authorities bring us closer to this goal." During the Latvian Presidency, under S. Henkuzens' leadership the Pharmaceuticals and Medical Devices Working Group of the EU Council reached an agreement regarding a common position on projects for regulations with the objective of modernising EU regulations related to medical devices and in vitro medical devices, and that is a significant step towards improving patient safety and strengthening the European competitive capacity. At the moment the Luxembourg Presidency has commenced a trialogue discussion with the European Parliament to approve the regulations in the nearest future. During the Dublin meeting special attention will be paid to issues related to strategic development of medical devices, including the role of compliance evaluation institutions in this process. The meeting agenda includes an open session where associations of notified bodies are invited to participate and where issues related to the assessment and perspectives of the notified bodies will be discussed within the context of future medical devices regulations. Discussions will also be held regarding activities laid down in the joint action "Market Surveillance of Medical Devices" under the European Commission Annual work plan for 2015. During the meeting the Director of the State Agency of Medicines will chair one of the sessions which will cover issues regarding interaction with other EU level working groups for medical institutions, working groups for clinical trials, market surveillance and coordination of notified bodies.
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1 During the Latvian Presidency of the EU Council a meeting of the national representatives of the competent institutions for medical devices from member states, European Economic Area countries and European Free Trade Association countries and of the representatives of the European Commission took place in Riga on 24th and 25th February 2015. | 
