Medical devices in the European Union (EU) have to undergo a conformity assessment to demonstrate that the general safety and performance requirements under the new Medical Devices Regulation (2017/745/EU) (MDR) are met.
Once a medical device has passed a conformity assessment, its manufacturer can obtain a CE (Conformité Européenne) Marking certification from a Notified Body, apply the CE Mark, and place the product on the market.
The new MDR was approved by the European Union in May 2017 and changed the European legal framework for medical devices, bringing EU legislation into conformity with technical advances, changes in medical science, and progress in law making. The MDR has a transitional period of four years and will fully apply from 26 May 2021, replacing the two existing medical devices directives, the Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD). Compared to the current Medical Devices Directives, the scope of the MDR is significantly increased as it focuses more on a safety life-cycle approach, supported by clinical data and post-market monitoring, meaning that the market access framework for all member countries of the European single market will change considerably.
The EU regulatory pathway for MIRACLE MIR-ATR arthroscopy device has been carefully reviewed to ensure it passes the compliance assessment process for CE-marking under the new MDR 2017/745.
Feature image author – @snowing
