Authentication and Tracking of Medical Devices
Anti-Counterfeiting of Medical Devices: Requirements from Europe to Australia
Requirements Around the Globe
Different regulations apply worldwide for the authentication and tracking of medical devices. We have taken a close look at this and show what requirements are placed on manufacturers around the globe.
The global medical device industry is one of the fastest-growing sectors of the economy. The number of products manufactured is constantly increasing and requirements are becoming stricter to protect manufacturers and consumers from counterfeit products. The resulting Medical Device Regulation refers to the rules and guidelines that govern the manufacture, marketing, and use of medical devices. The regulations are intended to ensure that medical devices are safe and effective and meet the required quality standards. For this purpose, in contrast to pharmaceuticals, no product serialization is currently used. However, certain medical devices are given a UDI (Unique Device Identification) - this product identifier is a unique numeric or alphanumeric code.
Regulations for Medical Devices
Medical devices are subject to different regulations around the world, but in most countries, they must be tested and certified before they can be sold. The testing and certification process can be long and expensive but is essential to ensure that medical devices are safe and effective for patients.
In the European Union, the regulation of medical devices is governed by the Medical Device Regulation (MDR), which came into force on May 26, 2021. The MDR replaces the former Medical Device Directive (MDD) and introduces stricter requirements for medical device manufacturers. Under the MDR, medical devices are divided into four risk categories depending on their intended use, with more extensive testing and certification required for higher-risk products.
In the United States, the regulation of medical devices is supervised by the Food and Drug Administration (FDA). Medical devices are divided into three categories based on their level of risk, with Class III devices (the highest risk category) undergoing extensive testing and requiring evaluation before they can be marketed.
Explanation of the Different Categories
Medical devices are classified into different categories depending on their intended purpose and the degree of risk to the patient. The classification system helps determine the appropriate level of regulatory review and control required to ensure the safety and effectiveness of the device. Classification systems can vary from country to country but generally have similar principles. Here is a general overview of the classification system:
Class I medical devices:
These are low-risk devices that are not intended to be used for invasive purposes and are generally considered to have the lowest potential risk to patients. Examples of Class I medical devices include dressings, stethoscopes, and tongue depressors.
Class II medical devices:
These are medium-risk devices that are frequently used for diagnostic or treatment purposes. They may pose a greater risk compared to Class I devices and require a higher level of regulatory control. Class II medical devices include, for example, electric wheelchairs, surgical gloves, and X-ray equipment.
Class III medical devices:
These are high-risk products that are often used for life-sustaining or life-supporting purposes, as well as pose a significant risk of illness or injury to patients. These products require the most extensive testing and clinical evaluation before they can be marketed. These include pacemakers, heart valves, and implantable defibrillators.
In addition to these classes, there are further classifications in some countries, such as Class IV in Canada. This class includes diagnostic and therapeutic devices with a very high increased risk for patients. Classification thus varies from country to country.
The European Database on Medical Devices (EUDAMED) is a centralized system developed by the European Commission to manage data related to medical devices. It is designed to ensure the safety and performance of medical devices sold in the European Union. The EUDAMED system is divided into six interrelated modules:
- Actor Registration
- UDI/Device Registration
- Vigilance & Post-Market Surveillance
- Clinical Investigation & Performance Studies
- Market Surveillance
- Notified Bodies & Certificates
In June 2022, the European Commission established a schedule for the development and implementation of the EUDAMED system. The first milestone is scheduled for the fourth quarter of 2023, by which time the development of the MVP (Minimum Viable Product) for all six modules should be completed. The MVP is a version of the system that meets only the minimum requirements for functionality. Following this, an independent audit is to take place in Q1-Q2 2024. The results of the audit will then be presented to the Medical Device Coordination Group (MDCG). If EUDAMED is fully functional after the audit, a system release notice will be published.
The use of EUDAMED will become mandatory in the coming years for various requirements related to medical devices. Starting in the fourth quarter of 2024, six months after the published notice, the use of EUDAMED will become mandatory in the context of Actor Registration, Vigilance & Post-Market Surveillance, Clinical Investigation & Performance Studies, and Market Surveillance modules. The move to mandatory use of EUDAMED represents a significant change for medical device industry stakeholders. Because the system will facilitate the exchange of information between the European Commission, Member States, Notified Bodies, and economic operators.
In the second quarter of 2026, after the end of the 24-month transition period, EUDAMED will become even more important for the medical device industry. From this point on, the use of EUDAMED will become mandatory for the requirements related to the UDI/Device Registration and Notified Bodies & Certificates modules. This means that all medical devices will be registered in EUDAMED with a unique device identification number (UDI) and all notified bodies and economic operators must be registered in the system.
In December 2022, the European Commission proposed to extend the transition period for the Medical Device Regulation (MDR), citing manufacturers' difficulties in complying with the regulation due to the COVID 19 pandemic. The proposed dates for the extended transition period run through 2026 for Class III implantable custom devices, 2027 for Class IIb and Class III devices, and 2028 for Class IIa and Class I devices.
The European Commission adopted these amendments on January 6. They will now go to the European Parliament and Council for a vote. If approved, the extended transition period will give manufacturers additional time to meet the requirements of the MDR while ensuring that patients have access to safe and effective medical devices.
In summary, the use of EUDAMED will be mandatory in the coming years for various obligations and requirements related to medical devices. The transition to mandatory use of EUDAMED represents a significant change for the medical device industry and will require all stakeholders to adapt and comply with the new requirements. The proposed extension of the MDR transition period provides additional time for manufacturers to meet the requirements.
The current agreement between Switzerland and the European Union (EU) on mutual recognition of conformity assessment (MRA) has not been updated. As a result, Swissmedic is responsible for the direct registration of economic operators (CHRN) and medical devices, including in vitro diagnostic medical devices.
In April 2022, Swissmedic started the implementation of the "swissdamed" database. The database is expected to go live in 2023, but the launch date may be delayed as it is being modeled after EUDAMED. The database consists of two interlinked modules: Economic Operators and UDI/Device Registration.
Three releases are planned for the swissdamed database. The first release will include the Economic Operators module, while the second release will include the UDI/Device Registration module. An exchange with industry is planned for the piloting of this module. The third and final release will contain priority 3 features and fixes.
In Australia, the Therapeutic Goods Administration (TGA) is the government agency responsible for regulating medical devices. The AusUDID testing environment was launched on July 4 for the pilot process in accordance with IMDRF guidelines. This initiative was open to any manufacturer or product sponsor willing to provide feedback to the TGA to refine its final requirements. The pilot project ran through December 2022.
The TGA is currently working on the final version of the regulation and is expected to publish it very soon. However, the timeframe for compliance with the regulation has yet to be confirmed. Voluntary compliance with the regulation should begin in January 2023, and mandatory compliance will be required by July 2027.
Efficiency and Effectiveness of the MDR
Overall, the MDR helps to increase confidence in medical devices and instruments and thus improves the well-being of patients. The requirement for clear identification of class III devices means a high bureaucratic burden for manufacturers. Thus, this could lead to higher costs, which may or may not be passed on to the end user at a later stage.
Another criticism could be that this results in fewer innovative products coming onto the market. Since manufacturers may rely on the use of standard components to simplify identification and reduce costs. This could hinder the development of new and innovative medical devices and thus enormously slow down progress in medical technology.
Ultimately, the effectiveness of clear identification of Class III devices depends on careful consideration of costs and benefits, as well as feasibility and efficacy. It is important that decisions are made based on sound data and analysis to ensure that patient safety remains assured while encouraging the development of new and innovative medical devices.
A guide might be the introduction of FMD (Falsified Medicines Directive), where the benefits of serialization at the individual item level outweigh the disadvantages after now more than 4 years after its introduction. You can read more about this here.
Arvato Systems and the author cannot guarantee the accuracy of the information given, as regulations and deadlines change daily. In case of doubt, please do not hesitate to contact the team directly.