What Our Clients Are Saying

“ECM has saved our business countless hours by speeding up the approval process. They know how to push through fast, while adhering to all standards.”
Alan C.

The current Medical Devices Directive – (MDD) 93/42/EEC is being replaced by the Medical Device Regulation – MDR 2017/745  (Regulation (EU) 2017/745) which came into force on May 25, 2017. The transitional period will end in 2020. The scope of the MDR has been extended to include additional devices.

The MDR has a transition period of three years and will replace the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC). Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

Some of the most notable changes included in the new regulation include:

  • Greater scrutiny of technical documentation
  • Increased concerns related to the assessment of product safety and performance
  • Stricter requirements for clinical aspects
  • Additional requirements for post-market clinical follow-up
  • Requirements for improved traceability of devices through the product supply chain
  • Cost efficiency

ECM has applied to become a Notified Body under MDR and expects designation sometime in 2019.

ECM experts are happy to discuss the new requirements of the MDR and guide your strategy for managing the transition.