(EU) 2017/745 Medical Device Regulation
In order to protect patient and user health, the European Union (EU) has made a major change in medical device directive with stricter requirements. Purpose of this process improve quality, safety and performance data in medical devices and to harmonize all sector stakeholders, whether manufacturers, notified bodies or competent authorities. The New Medical Device Regulation came into force on May 25, 2017 and started to be implemented as of May 26, 2021 (DoA - Date of Application) with the completion of the four-year transition period. The implementation of the 93/42/EEC Medical Device Directive (MDD) has also ended as of this date.
Enhancements Introduced by MDR
The implementation of the New Medical Device Regulation (MDR) ushered in a series of improvements aimed at fortifying the quality and safety standards of medical devices, fostering transparency, and ensuring robust post-market surveillance. The key enhancements include:
- Stricter Preliminary Control for High-Risk Devices
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A novel pre-market review mechanism has been established at the EU level, involving a pool of experts, to impose more rigorous scrutiny on high-risk devices.
- Strengthened Criteria for Notified Bodies
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Criteria for the appointment and oversight of Notified Bodies have been reinforced, ensuring a higher standard of competence and reliability.
- Expanded Scope to Include Aesthetic Devices
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Certain aesthetic devices, sharing features and risk profiles with analogous medical devices, are now encompassed within the regulatory framework (Annex XVI).
- Enhanced Transparency through EUDAMED
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The introduction of a comprehensive EU database on medical devices (EUDAMED) has significantly improved transparency within the sector.
- Traceability System Based on UDI
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A traceability system, rooted in the Unique Device Identification (UDI) system, enhances the ability to track and monitor medical devices throughout their lifecycle.
- Mandatory `Implant Card`
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The regulation now mandates the provision of an "implant card" containing crucial information for patients with implantable medical devices, promoting awareness and patient safety.
- Strengthened Rules on Clinical Evidence
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A more robust framework for clinical evidence has been established, incorporating an EU-wide coordinated procedure for authorizing multicenter clinical trials.
- Enhanced Post-Market Surveillance Requirements
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Manufacturers are now subject to intensified post-market surveillance requirements, ensuring prompt identification and response to any emerging issues.
- Improved Coordination Mechanisms
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Mechanisms for coordination on vigilance and market surveillance among EU countries have been refined, fostering a collaborative approach to ensuring the safety and efficacy of medical devices.
- Robust Financial Compensation Mechanism
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The implementation of a robust financial compensation mechanism empowers patients to seek compensation for any harm caused by defective devices, reinforcing accountability within the industry.
Application Forms
- (EU) 2017/745 Medical Device Regulation
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(EU) 2017/745 Medical Device Regulation
Product Information
UDEM Certificate
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