European Commission 20 July 2018
This Factsheet is aimed at manufacturers of medical devices.
References to Annexes and Articles in this factsheet refer to the MDR (2017/745/EU)
The new Medical Devices Regulation (2017/745/EU) (MDR) and the In-vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making.
The new Regulations will create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers.
In contrast to Directives, Regulations do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.
Transitional periods are planned to smooth the application of the new Regulations. However, you should bear in mind that consultants, in-house professionals, and Notified Bodies will all get busie.
- Implementation Model for MDR step by step guide;
- New EU Rules to Ensure Safety of medical devices;
- Facsheet Manufactures of Medical devices.
Ed 1.0 Gennaio 2018
Regolamento (UE) 2017/745 del Parlamento Europeo e del Consiglio del 5 aprile 2017 relativo ai dispositivi medici, che modifica la direttiva 2001/83/CE, il regolamento (CE) n. 178/2002 e il regolamento (CE) n. 1223/2009 e che abroga le direttive 90/385/CEE e 93/42/CEE del Consiglio. (GUUE L117/1 del 05 maggio 2017)
Disponibile il testo del Regolamento Riservato Abbonati Marcatura CE in formato PDF navigabile e stampabile/copiabile.