Transitional period Medical Devices Regulation (EU) 2017/745
The Medical Devices Regulation (EU) 2017/745 (hereafter: MDR) entered into force on May 26th, 2017. The MDR replaces both the Medical Device Directive 93/42/EEC (hereafter: MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (hereafter: AIMDD). In order to ensure a smooth transition a transitional period of three years has been implemented. This means that until May 26th, 2020 medical devices may also comply with the requirements of the MDD and AIMDD.
Conformity assessment procedures
Manufacturers of medical devices of class I are responsible for complying with the legal requirements. As the MDR is already in force, it is highly recommendable to comply with the requirements stated in the MDR, as the MDD will be repealed after the transitional period.
For all medical devices with a risk class higher than class I, an assessment by a Notified Body is required. Even though the MDR is already in force, the Notified Bodies are not yet accredited to perform assessments on the basis of the MDR. This means that an assessment by a Notified Body of your medical device shall be based on the MDD and/or the AIMDD. As we are progressing to the end of the transitional period, more Notified Bodies will be accredited in accordance with the MDR.
ISO 13485:2016 Quality System