Zarówno nasze produkty jak i systemy zarządzania jakością, nadzoru rynku i rejestracji produktów są dostosowywane do obowiązujących przepisów w przewidzianych terminach.
MDR – jesteśmy gotowi
As of 26 May 2021, a new legislative act – Medical Device Regulation 2017/745 – is effective in all EU member states. Mercator Medical S.A. would like to inform that both our products and our quality management, market surveillance and product registration systems are in compliance with the applicable law within the relevant periods.
MDR czyli Medical Device Regulation
MDR (Medical Device Regulation), or Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 on medical devices supersedes as of 26 May 2021 the Medical Devices Directive and Regulation (EU) 2017/745 on medical devices applicable until then.
Co się zmienia?
MDR assumes the establishment of high quality standards for medical devices and the unification of the rules of their placement and use on the EU market. Product documentation requirements have been tightened up, and the focus on the acquisition of feedback and product supervision in the context of the entire supply chain has been increased. The Mercator Medical Group is ready for new regulations as a manufacturer, importer and distributor of single-use medical devices. Our products comply with applicable EU laws and regulations, including MDR.
Kogo dotyczy MDR?
The requirements are now specified more precisely and encompass the entire medical product supply chain. Manufacturers, importers and distributors face many new challenges. The Mercator Medical Group has worked on ensuring conformity with the new MDR for a long time and has complied with MDR for all Class I medical devices since May 2021. We are ready to provide our customers and partners with relevant technical information and necessary documentation.