EU 2017/745 MDR
The EU 2017/745 Medical Device Regulation (MDR) is a comprehensive regulatory framework that governs the production, distribution, and post-market surveillance of medical devices within the European Union. This regulation replaces the previous Medical Device Directive (MDD) and introduces more stringent requirements to ensure the safety, performance, and efficacy of medical devices. The EU MDR came into full effect on May 26, 2021. Manufacturers of medical devices must comply with the regulation's requirements to maintain market access in the European Union.
CE marking under EU 2017/745 indicates a medical device's compliance with stringent safety and performance standards. CE stands for Conformité Européenne. It certifies that the device meets all regulatory requirements, allowing it to be sold within the European Union and ensuring market access.
Key Objectives
Enhance Patient Safety: The MDR aims to improve patient safety by enforcing stricter controls on medical devices, including more rigorous clinical evaluations and increased post-market surveillance.
Ensure High Quality and Performance: The regulation mandates robust quality management systems (QMS) to ensure that medical devices consistently meet high standards of quality and performance.
Increase Transparency: MDR enhances transparency through improved traceability of medical devices via unique device identification (UDI) and publicly accessible information about devices and manufacturers.
Major Requirements
CE Marking
Medical devices must obtain CE marking to be sold within the EU. This marking indicates conformity with MDR requirements, including safety and performance standards, ensuring the device meets stringent regulatory criteria for market access.
Technical Documentation
Manufacturers are required to compile comprehensive technical documentation demonstrating MDR compliance. This includes detailed information on device design, manufacturing processes, clinical evaluations, and risk management, serving as vital evidence throughout the device's lifecycle.
Clinical Evaluation
The regulation necessitates thorough clinical evaluations to substantiate the safety and performance claims of medical devices. This includes pre-market clinical investigations and post-market follow-up, providing robust evidence for MDR compliance.
Quality Management System (QMS)
Manufacturers must implement and maintain a Quality Management System (QMS) in line with the MDR to ensure ongoing regulatory compliance. This involves systematic processes for design, production, and post-market activities, supporting continuous improvement.
Risk Management
MDR mandates rigorous risk management processes throughout the device lifecycle, from initial design to post-market surveillance. Manufacturers must identify, assess, and mitigate potential risks associated with their devices, ensuring patient safety.
Post-Market Surveillance
Continuous monitoring of devices in the market is required to promptly identify and address any issues. Manufacturers must establish and maintain a post-market surveillance system to gather and analyze data on device performance and safety.
Notified Bodies
Devices are subject to assessment by Notified Bodies, independent organizations designated to evaluate conformity with MDR requirements. Notified Bodies play a crucial role in the certification process, ensuring compliance and market readiness.
MDR Medical Device Classification
Under Article 51 of the EU Medical Device Regulation (MDR), medical devices are categorized into Classes I, IIa, IIb, and III, based on their intended purposes and inherent risks. The risk increases incrementally from Class I to Class III. Both the Medical Device Directive (MDD) and the MDR utilize a rule-based classification system for medical devices.
The new MDR introduces 22 classification rules in Annex VIII. Determining the appropriate EU MDR medical device classification and corresponding rule is the initial step in the EU CE marking process. Based on the classification and rule, manufacturers can compile the technical documentation and submit the Notified Body application. This process ensures that devices comply with the stringent regulatory requirements for safety and performance.
MDR Classification and Device placement
Non-Invasive Devices
Non-invasive devices, which operate outside the body, generally pose lower risks and are categorized under Class I or Class IIa. These devices do not penetrate the body, hence the lower associated risk.
Invasive Devices
Invasive devices, which pierce or enter the body through an opening or its surface, are considered higher risk. Due to the nature of their use, they are typically classified under Class IIb or Class III.
Active Devices
Active devices rely on an external power source, such as electricity, batteries, or chemicals, to function. Given their dependence on external power and potential complexity, these devices usually fall under Class IIb or Class III, reflecting their higher risk.
MDR Classification and Duration of Use
Transient Devices
Transient devices are intended for continuous use for less than 60 minutes.
Short-Term Use Devices
Short-term use devices are intended for continuous use between 60 minutes and 30 days.
Long-Term Use Devices
Long-term use devices are intended for continuous use for more than 30 days.
Medical Device Classification with Examples
Class I - Low Risk
Devices that pose minimal risk to the patient and user.
Examples: Bandages, Stethoscopes, Corrective glasses, Non-powered wheelchairs, Thermometers.
Type of Certification: Self-Certification or Self-Declaration.
Class Is - Low Risk (Sterile)
Sterile devices that pose minimal risk but require sterility.
Examples: Sterile dressings, Personal protection kits, Sterile catheters.
Type of Certification: Notified Body.
Class Im - Low Risk (Measuring Body Attributes)
Devices that measure body attributes with minimal risk.
Examples: Blood pressure cuffs, Thermometers, Weighing scales.
Type of Certification: Notified Body.
Class Ir - Low Risk (Reusable Devices)
Reusable devices that pose minimal risk.
Examples: Reusable surgical instruments, Reusable endoscopes, Reusable forceps.
Type of Certification: Notified Body.
Class IIa - Medium Risk
Devices that have a moderate risk and are used for short-term or transient use.
Examples: Hearing aids, Ultrasound machines, Contact lenses, Dental fillings, Blood pressure monitors.
Type of Certification: Notified Body.
Class IIb - Medium to High Risk
Devices that pose a higher risk due to their invasive nature or prolonged use.
Examples: Infusion pumps, Ventilators, Bone fixation plates, Dialysis machines, Surgical lasers.
Type of Certification: Notified Body.
Class III - High Risk
Devices that pose the highest risk to patients and users, often involving life-sustaining functions or significant invasive procedures.
Examples: Pacemakers, Heart valves, Implantable defibrillators, Artificial joints, Cochlear implants
Type of Certification: Notified Body.
Rules of Medical Device Classification
According to EU MDR Annex VIII the devices are classified and by adhering to these classification rules, manufacturers can ensure that their medical devices comply with the EU MDR, facilitating the CE marking process and ensuring patient safety.
Rules 1–4: Non-Invasive Devices
Non-invasive devices are generally classified as Class I medical devices. However, depending on their specific use and associated risks, some non-invasive devices may fall under Class IIa, Class IIb, or even Class III. These rules ensure that devices posing varying levels of risk are appropriately classified.
Rules 5–8: Invasive Devices
Invasive devices, which enter the body either through an opening or by penetrating the body surface, are primarily classified as Class IIa, Class IIb, or Class III medical devices due to their higher risk. However, certain low-risk invasive devices may still be classified as Class I under these rules.
Rules 9–13: Active Devices
Active devices, which rely on an external power source such as electricity, batteries, or chemicals, can be classified across all risk categories: Class I, Class IIa, Class IIb, and Class III. The classification depends on factors such as body placement and duration of use, reflecting the varying levels of risk associated with these devices.
Rules 14–22: Special Rules
Special Aspects of MDR Classification
The EU 2017/745, specifically Annex XVI, includes a list of beauty devices now classified as medical devices. This significant update ensures that various cosmetic and aesthetic devices adhere to stringent medical device regulations to enhance safety and efficacy.
Included Beauty Devices:
Contact Lenses:
Different kinds of lenses, including fun lenses and non-prescription colored contact lenses, are now regulated to ensure safety and quality.
Cosmetic Implants:
Implants without a medical function, such as breast implants for cosmetic purposes, are included. Previously, only medical implants were covered.
Cosmetic Fillers:
Cosmetic fillers used for lip augmentation and wrinkle reduction are now classified under medical device regulations to ensure proper usage and minimize risks.
Liposuction Devices:
Devices and instruments used for liposuction, lipolysis, and lipoplasty are regulated to ensure safe and effective fat removal procedures.
Light-Emitting Devices:
Lasers and intense pulsed light (IPL) devices used for hair removal, tattoo removal, skin treatment, and resurfacing are included to regulate their use and prevent potential harm.
Brain Stimulation Devices:
Devices used to stimulate or influence moods are now considered medical devices, ensuring they meet safety and efficacy standards.