The shift towards the Medical Device Regulation (MDR) signifies a major transformation within the medical device sector in the European Union and its global partners.
This journey through MDR transition is crucial for:
- Manufacturers
- Stakeholders, and
- Regulatory entities
aligning with the new regulatory norms to secure compliance, market presence, and the ongoing guarantee of device safety and efficacy.
Deciphering the MDR Transition:
Grasping the MDR transition entails an in-depth understanding of the pivotal changes initiated by moving from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) in the European Union.
This shift heralds a thorough overhaul designed to elevate the safety, efficacy, and quality of medical devices entering the market.
An exploration of the MDR transition’s significant aspects and its implications for manufacturers, stakeholders, and the healthcare sector is presented herein.
Origins of the MDR Transition:
Prompted by escalating concerns regarding patient safety and medical device efficacy, along with high-profile instances of device-related failures, the European Union introduced the MDR to enforce stricter regulatory oversight and bolster protection for users.
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