In May of 2017 State Health Care Accreditation Agency (hereinafter – Accreditation Agency) attended  the meeting of the Regulatory  Committee on Medical Devices and the special expert meeting on future implementing acts under new medical devices regulations which was organized by the European Commission.

           The Medical Devices Regulatory Committee on Medical Devices voted in favour of the Commission decision on the qualification of cranberry products.  The Commission decision stated that the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis, are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive. The formal adoption and publication of the decision are expected in summer.

           The aim of the special expert meeting – to discuss the preliminary drafts of the future Commission Implementing regulations. During the meeting several preliminary drafts were discussed: Commission Implementing Regulation on Common Specification for the reprocessing of single use medical devices, Commission Implementing Regulation on the application for designation as Notified Bodies in the field of medical devices and in vitro diagnostic medical devices, Commission Implementing Regulation on the codes and corresponding types of devices describing the scope of designation of Notified Bodies in the field of medical devices and in vitro diagnostic medical devices.

          European Commission presented progress report on the development of the future EUDAMED, made a presentation on the future set up of new Medical Devices Coordination Group (MDCG) and subgroups. It was stressed that Member States will have to adopt their national legislation according to the new regulations in a harmonised manner. Therefore cooperation and communication between Member State and the European Commission is of outmost importance.

           “Accreditation Agency - as Lithuanian Competent Authority in the field of Medical Devices - actively participates in expert meetings dealing with the new Medical Devices Regulations. These Regulations are very important for our patients and health care professionals.  One of the most important issues – reprocessing of single use medical devices. Currently reprocessing of single use medical devices is not allowed in Lithuania and we do not have much experience in this field. Therefore we have carefully evaluate our capability and possible consequences of this process,” - says Nora Ribokien─Ś, director of the Accreditation Agency.



Informacija atnaujinta 2017-06-05



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