What Is MDR In Medical Technology

Introduction: What Is MDR In Medical Technology? The FDA acquires several hundred thousand medical device reports of suspected device-related deaths, serious injuries, and malfunctions each year. 

Medical Device Reporting (MDR) is one of the post market surveillance tools that the FDA uses to monitor device interpretation, detect potential device-related safety issues, and assist in the benefit-risk assessment of these products. 

What Is MDR In Medical Technology

In addition, although MDRs are a valuable origin of information, this passive surveillance system has limitations. Underreporting of incidents, errors in reports, lack of confirmation that the device caused the reported incident, and lack of information about the frequency of use caused the occurrence, prevalence, or occurrence of an incident. 

The cause cannot be determined by this reporting system alone. Because of these limitations, MDRs constitute only one of the FDA’s important post market surveillance data sources.

What Is MDR In Medical Technology

MDR stands for Medical Device Regulation, a set of regulations for medical devices sold in the European Union (EU). The MDR replaced the previous Medical Device Directive (MDD) in 2017, and its application began on May 26, 2021.

The new MDR aims to improve safety and efficiency in the EU medical device market. The predecessor of MDR, The Active Implantable Medical Devices Directive (AIMDD) and the Medical Devices Directive (MDD), introduced in the early nineties, have long served their purpose and helped shape the medical device market in Europe.

However, Medical Device Contract Development and Manufacturing Organizations (CDMO) revealed some weaknesses in implementing these guidelines. Along with scientific and technological progress, there was also a need for change in legislation.

The MDR includes several new requirements and changes compared to the MDD, including:

  1. Increased scrutiny of high-risk devices: The MDR introduces new requirements for manufacturers of high-risk devices, such as implants and Class III devices, including providing clinical data demonstrating safety and effectiveness.
  2. More rigorous requirements for clinical investigations: The MDR requires that clinical investigations be conducted according to good clinical practice (GCP) guidelines, which include requirements for informed consent, patient safety, and data quality.
  3. Introduction of Unique Device Identification (UDI): The MDR requires that medical devices be labeled with a UDI. This unique code identifies the device and allows it to be traced throughout its life cycle.
  4. Increased transparency and reporting requirements: The MDR requires that manufacturers report certain adverse events related to their devices to regulatory authorities and make this information publicly available.
  5. More stringent requirements for notified bodies: The MDR introduces new requirements for notified bodies, which are organizations that assess and certify medical devices for compliance with regulatory requirements.

5 Key elements of the New Medical Device Regulation (MDR)

Placing medical devices on the European market is complex, and new legislation can be difficult to understand. The new Medical Device Regulation includes several important changes. Here are some key aspects and how Elvis Med tech prepares to meet the new regulation.

  1. The application date for the new MDR is set for May 2022. The new MDR was approved and came into effect in May 2017. For all CDMOs, including Elos Med tech, there is now a three-year transition period to implement the new regulation. Elos Med tech is now reviewing our medical devices’ technical documentation to be ready for 2022.
  1. Longer time to place the product in the medical device market the new MDR means getting a medical device on the European market may take longer to keep there. To be prepared for this, we are looking at investing in talent, capacity, training, and equipment to enhance our performance.
  1. Greater pressure on notified bodies and competent authorities the new MDR also risks raising the workload for notified bodies, qualified authorities, and the European Commission. This means processing regulatory, clinical and certification activities will take longer. 
  2. Require all medical devices to be reevaluated for compliance and certification. All medical devices must be re-evaluated with the new Medical Device Regulation to ensure they comply with the requirements and certification. 
  1. Compensation for damage caused by defective medical equipment. Consumers can appropriate compensation for damage caused by defective equipment. With the new MDR, in the case of non-European manufacturers, the authorized representative will also be held liable alongside the manufacturer. 

Mandatory Medical Device Reporting Requirements

The Medical Device Reporting (MDR) regulation includes mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse circumstances and product problems to the FDA.

Manufacturers: Manufacturers must report to the FDA when they learn that one of their devices has caused death or serious injury. Manufacturers must also notify the FDA when they become aware that their device has developed a defect and if a recurrence of the defect could cause or contribute to death or serious injury.

Device User Facilities: A device user facility is a clinic, walking surgical facility, nursing home, outpatient diagnostic facility, or outpatient medical facility, not a physician’s organization. User facilities must report suspected medical device-related deaths to the FDA and the factory.

User facilities must report a serious medical device-related injury to the manufacturer or the FDA if the manufacturer of the medical device is unknown.

Importers: Importers must report to the FDA and the manufacturer when they become aware that one of their devices may cause or contribute to death or serious injury.

The importer must notify the manufacturer only if their imported equipment has developed a defect, and the recurrence of the defect could cause death or serious injury.

Final Words

The MDR is a set of regulations designed to improve patient safety and ensure that medical devices are safe, effective, and manufactured to a high-quality standard.

It introduces several new requirements and changes compared to the previous regulatory framework, and compliance with the new regulations is mandatory for medical devices sold in the EU.

The MDR has significant implications for manufacturers of medical devices, as compliance with the new regulations is mandatory for devices sold in the EU. The MDR also has implications for healthcare providers, who must ensure their devices comply with the new regulations.

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