What is the Medical Device Regulation(MDR)?

EU Medical Device Regulation MDR 2017/745
The European Union has adopted a new medical device regulation, the MDR [Medical Devices Regulation (MDR 2017/745)]. This is a new leap forward in the medical device industry to enhance patient safety and modernize public health. The European Commission officially announced the MDR on May 5, 2017, and entered into force on 25 May 2017. Therefore, medical device manufacturers were given a three-year transition period up to May 25, 2020. This new regulation will replace the existing Medical Device Directive (MDD) [Medical Devices Directives (93/42 / EEC)] and the Active Implantable Medical Device Directive (AIMDD) [Active Implantable Medical Devices Directives (90/385 / EEC)].
The IVDR [In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746)], which will replace the in vitro diagnostic medical device directives will be effective from May 26, 2022.

Which directives apply to MDR?
Medical Device Directive (93/42/EEC), Active Implantable Medical Device Directives (90/385/EEC).

What is the Key changes?

- Identification of responsible person for regulatory compliance (Manufacturer, EU representative)
- Implementation of unique device identification (UDI) for medical devices
- More strict clinical requirements for certain high risk products (Implantable medical device, Class III products)
- Establishment of European database on medical devices (EUDAMED)
- Strengthening requirements for clinical evaluation and clinical evidence
- Conformity assessment applied according to common specifications
- Strengthening of post-market surveillance requirements for manufacturers (PMS, PSUR, SSCP and etc)
- Product scope expansion [Products without an intended medical purpose, Annex XVI to Regulation (EU)2017/745]

How do manufacturers prepare for the MDR?

As MDR replaces the existing directives that have been applied to medical devices in the Europe market, manufacturers are required to conduct conformity assessment by MDR notified bodies to demonstrate compliance with the new regulations. Medical devices other than Class 1 medical devices need to be aware of the requirements for new regulations and identify solutions that will impact their products or non-compliance with new regulations and come up with ways to resolve them quickly.

How do Notified bodies follow up on MDR?

MDR notified bodies conduct on-site surveillance audits annually in accordance with European medical device regulations.

Contact Person

An SeungIn

asi@icrqa.com