CeCert on the way to MDR and IVDR

Last week we had the pleasure to participate as an exhibitor at International Trade Fair of Medical Equipment and Equipment SALMED . From this place, we would like to thank all our visiting guests for many inspiring discussions, not only on topics related to medical devices. We do not hide that it was our debut, which we consider very successful. It was also successful because during the speech of Dr. Michał Pachowski on the “Stage of Trends in Medicine” we announced to the assembled audience that we would submit an application for designation as a notified body in the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on on Medical Devices (MDR) . We sincerely hope that, after formally assessing our application, & nbsp; later this year, our unit will be assessed by the JAT – Joint Assessment Team.  

Due to the ending period of application of Directive 98/79/EC, we can also confirm that the CeCert team is working on the preparation of an application for designation as a notified body in the scope of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices . The planned date for submitting the relevant documents is the turn of the 2nd and 3rd quarter of this year.  

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