Are you prepared for the changes?
The Medical Device Regulation (EU) 2017/745 was published in May 2017 and replaces the Medical Device Directive (MDD) 93/42/EEC. The Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC have come under criticism in recent years.
Both the MDD and AIMD are combined under the new regulation which aims to overcome the current flaws and divergences and further strengthen patient safety via a robust, transparent and sustainable regulatory framework that is ‘fit for purpose’.
- Key changes introduced in MDR:
- Scope of regulated medical devices
- Pre-market scrutiny procedure
- Classification Rules
- Conformity assessment procedures
- Person responsible for regulatory compliance
- Supervision of Notified Bodies
- Timetable for introduction and transition.
The position of Notified Bodies in relation to manufacturers is significantly strengthened. They have a right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on devices.
By proactively taking certain measures, such as accessing the documentation, will ease the introduction and transition to the new regulation.
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