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Overview of the International Conference on Harmonisation with the EU Medical Devices Legislation

On May 14-15, 2009, in Hotel Medena in Seget Donji, an International Conference on Harmonisation with the EU Medical Devices Legislation was jointly organised by the Croatian Agency for Medicinal Products and Medical Devices (ALMP), the Croatian Pharmaceutical Society (HFD) and the Embassy of the French Republic in Croatia. The conference was held under the auspices of the Ministry of Health and Social Welfare of the Republic of Croatia as a follow up to the symposium on the Approval, Marketing and Surveillance of Medical Devices held on November 6, 2006 in Split.

On behalf of the Minister of Health and Social Welfare, the conference was opened by the Director General of the Croatian Institute of Health Insurance, Mr. Tihomir Strizrep. Opening addresses were also given by the Head of the ALMP, Assistant professor Siniša Tomić, PhD (Speech of the Head of the ALMP-in Croatian); General Secretary of the HFD, Assistant professor Maja Jakševac Mikša, PhD; Deputy Prefect of Split-Dalmatia County Mrs. Anđelka Vuković, and Mr. Denis Dobo-Schoenenberg, Advisor for Culture and Cooperation, Embassy of the French Republic in Croatia.

The conference was attended by around 160 participants involved in the manufacturing, approval, labelling, marketing and safety monitoring procedures of medical devices in Croatia. Lectures were given by speakers from Belgium, Montenegro, France, Croatia, Canada, Slovenia, Switzerland and the European Commission, who presented all key topics from the field of medical device legislation derived from the so-called New Approach Directives of the acquis communautaire.

Among the speakers were representatives of regulatory bodies, academia, notified bodies and medical device manufacturers' associations, who also addressed market surveillance and medical device safety, presenting specific experiences in the field of medical devices in individual countries (Montenegro, Slovenia, Canada, France, Switzerland and Belgium).

At the start of the Conference, Mrs. Rita L`Abbate from the Enterprise and Industry Directorate-General of the European Commission presented the new legislative framework for market surveillance in the European Union. She particularly stressed the obligation to introduce the rapid alert system, so-called RAPEX. From January 1, 2010, this system will enable a rapid response in case of a serious risk related to product use in all member countries. The lecturers from Croatia presented the new Medical Devices Act which came into effect in October 2008, fully harmonised with the EU legislation. Particular emphasis was placed on the safety monitoring (vigilance) system for medical devices in the Republic of Croatia, where the ALMP, in case of a defective medical device, undertakes appropriate regulatory measures, which may include urgent withdrawal of the product from the market. Detailed information on defective medical devices reporting were provided at the medical devices vigilance workshop held by the ALMP's experts within the framework of the conference. The participants were also informed about the difficulties experienced by medical device manufacturers when it comes to assessment of medical device conformity (certification). The manufacturers pointed to the lack of a conformity assessment body for medical devices in Croatia as one of the problems. In connection therewith, the participants were invited to join in the debate, with EU speakers emphasising that any Croatian manufacturer can apply for a conformity assessment of its medical device with any notified body in Europe. The Croatian manufacturers thus have a parallel access to the markets of Croatia and the EU.

The basic objective of this conference, strengthening collaboration among the Croatian, European and world experts in the field of medical devices and informing all those concerned with the medical device legislation about the new guidelines in this field, has been achieved.

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Overview of the International Conference on Harmonisation with the EU Medical Devices Legislation