TRAINING ON MEDICAL DEVICES MARKET SURVEILLANCE HAS BEEN ORGANIZED

TRAINING ON MEDICAL DEVICES MARKET SURVEILLANCE HAS BEEN ORGANIZED

During 19-23 March 2018, the last session of the Training on Medical Devices Market Surveillance was organized at the Medicines and Medical Devices Agency in respect of the Activity 3.2 “Training of MMDA in respect of medical devices” of the EU-funded Twinning Project.

During the training the topics of conformity assessment procedures, risk management and quality managements systems, designation and monitoring of notified bodies, audits and assessments performed by notified bodies, community market surveillance and controls of medical devices entering the community, as well as other aspects that are under the Directives concerning medical devices were presented and discussed with the MMDA experts. As well, Polish experts shared their practical knowledge and experience on the medical devices market surveillance in the Republic of Poland. 

Participants of the course learned how to assess particular parts of conformity assessment documentation (incl. clinical evaluation reports, risk analysis etc.) and how to perform inspections and controls in the registered offices of manufacturers, distributors, etc. As the additional part, the participants got trained in assessing of the documentation concerning clinical trials conducting on medical devices with regards to Good Clinical Practice (EN ISO 14155:2011).

The activity was divided in three missions and was implemented by Short Term Experts from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of the Republic of Poland, Mr. Kamil Szczurowski and Mr. Tomasz Koeber, whom shared their experience and provided answers to the questions raised by the participants. 

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(c) 2015. Agenţia Medicamentului şi Dispozitivelor Medicale