MDR 2017/745 (Medical Device Regulation)
Definition
MDR 2017/745 refers to Regulation (EU) 2017/745 on medical devices, which is the European Union’s comprehensive legal framework governing the production, distribution, and monitoring of medical devices within the EU market. It replaced the previous Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) and came into full application on May 26, 2021.
This regulation aims to ensure a high standard of safety and performance for medical devices, enhance transparency, and strengthen post-market surveillance across EU member states.
Detailed Explanation
Purpose and Importance of MDR 2017/745
The primary objective of MDR 2017/745 is to improve patient safety and ensure that only safe and effective medical devices are placed on the EU market. This regulation introduces more stringent requirements for clinical evaluation, conformity assessment, and post-market surveillance, reflecting the EU’s commitment to public health and innovation.
Key Changes Introduced by MDR 2017/745
- Stricter Classification Rules: Devices are now subject to more rigorous classification, especially software and diagnostic devices.
- Unique Device Identification (UDI): A system to improve traceability and facilitate recalls if needed.
- Expanded Scope: MDR now includes certain aesthetic and non-medical devices (e.g., colored contact lenses, liposuction equipment).
- Increased Transparency: The European Database on Medical Devices (EUDAMED) enhances public access to device information.
- Greater Scrutiny of Notified Bodies: Notified Bodies must meet stricter designation criteria and are subject to ongoing monitoring.
- Post-Market Surveillance: Manufacturers must implement proactive PMS systems to monitor device performance after market launch.
Who Must Comply with MDR 2017/745?
The regulation applies to all manufacturers, importers, distributors, and authorized representatives of medical devices within the EU. Non-EU manufacturers must appoint an EU-based authorized representative to act on their behalf.
Clinical Evaluation and Conformity Assessment
Manufacturers must provide robust clinical data to demonstrate the safety and performance of their devices. Depending on the device classification, conformity assessment procedures may involve a Notified Body. The regulation also mandates the use of harmonized standards and common specifications where applicable.
Examples of Devices Affected
- Class I: Bandages, wheelchairs
- Class IIa: Dental fillings, surgical clamps
- Class IIb: Ventilators, infusion pumps
- Class III: Pacemakers, heart valves
Software intended for medical purposes, such as diagnostic or monitoring tools, may also be classified as medical devices under MDR, with classification based on their intended use and risk profile.
Impact on the Life Sciences Industry
The MDR 2017/745 regulation has significantly impacted the pharmaceutical and life sciences industries by aligning medical device regulation with broader EU health policy objectives. Companies must now invest more in regulatory affairs, quality assurance, and clinical evaluation to maintain compliance and market access.
Transitional Provisions and Deadlines
Although MDR came into effect in May 2021, transitional provisions allow for certain legacy devices to remain on the market until their certificates expire or until May 2024, provided they meet specific conditions. Recent amendments have extended some deadlines further, depending on the device class and compliance status.
