Resolve your challenges
to meet the obligations of the requirements of the MDR and IVDR regulations
Professional regulatory consultancy
Meet the obligations of the requirements of the MDR and IVDR regulations
Finding the right consultant is challenging.
I work on the principle of getting to know your field of activity and the current situation better, which is the basis for helping and guiding you with my knowledge and experience in finding right solutions for you. In addition, I regularly monitor innovations in the field (MDR / IVDR), inform you, and warn you of their impact on your business.
The new legislative framework (MDR / IVDR) changes the obligations of economic operators operating in the field of medical devices, so it is necessary to identify critical points in the production and distribution process in order to comply with all legislative requirements. The daily challenges and questions of what an economic operator has to follow do not run out, especially if we are aware that the field of medical devices is one of the fastest growing sectors, especially, the field of new technologies and innovations.
I offer the service of quick searching for a suitable notified body in one-step for manufacturers of medical devices and in vitro diagnostic devices.
The main changes introduced by the new legislative framework of regulations compared to the directives are:
- Updated rules are in place, including an implant card and patient information,
- The Single Registration Number (SRN) will identify the economic operator (manufacturer, authorized representative, importer) in the European Medical Device Database (EUDAMED),
- The unique device identifier (UDI) on the label of the medical device or its packaging will make it possible to find any medical device on the European Union market in EUDAMED,
- Products without a intended medical purpose are now covered by the MDR (Annex XVI of the MDR), which will have to meet the obligations set out in the MDR regulation,
- The new legislation places greater emphasis on the monitoring of medical devices over their “lifetime” and post market surveillance after placing on the market (PMS).
The European Commission’s goal in adopting the MDR / IVDR is a new legislative framework that provides safe and effective medical devices and IVD medical devices for the entire population of the European Union on the market.
The free movement of goods in the field of medical devices shall apply in the territory of the European Union.
I advise economic operators in the field of medical devices and adapt my services to the individual requirements and needs of clients.
MedDev Rešitve, Marcia Elena Podboršek s.p.
Dragomelj 78A, 1230 Domžale, Slovenia
00386 41 556 499