The Medical Device Regulation (MDR) is a comprehensive legislative framework that redefines how medical devices are designed, manufactured, and distributed across the European Union. More than just a set of rules, the MDR imposes stringent requirements aimed at drastically improving transparency, traceability, and overall product reliability within the medical sector. This regulation is essential as it tackles both longstanding and emerging challenges in medical technology, such as the rapid advancement of device innovation and the integration of software as a medical device.

For stakeholders in the medical industry — manufacturers, distributors, resellers and importers — understanding and adhering to the MDR is paramount. The regulation affects nearly every aspect of the medical device lifecycle, from initial design through post-market surveillance. Compliance is not merely about legal necessity; it is critical to maintaining trust and safeguarding user health. Non-compliance could result in heavy fines, withdrawal of products from the market, and significant damage to brand reputation.

Furthermore, the MDR is designed to ensure that all devices, whether they are cutting-edge robotic surgical aids or simple diagnostic tools, undergo rigorous testing and evaluation before they reach the market. This ensures that all medical devices used within the EU are safe, effective, and of the highest quality, which in turn supports public health and maintains the integrity of the European single market.

In the following sections, we will delve into the top 10 changes introduced by the MDR, highlighting how each change impacts the roles and responsibilities of those involved in the medical device industry. This guide will provide clarity and actionable insights to help stakeholders navigate this complex regulatory environment successfully.

Under the new MDR, the definition of what constitutes a medical device has been significantly broadened. This includes not only traditional medical devices but also non-medical and aesthetic devices such as dermal fillers, which were not previously regulated under the older Directive. This change aims to ensure that all products that have a medical purpose meet rigorous safety standards.

The Medical Device Regulation (MDR) introduces new rules for classifying medical devices into Class I, Class IIa, Class IIb, and Class III, reflecting the level of risk associated with their intended use. This classification system is crucial because it determines the level of control necessary to ensure the safety and effectiveness of devices before they reach the market.

 

• Class I Devices: These are the lowest risk devices and typically include non-invasive products like bandages, patient transport equipment (stretchers, stair chairs, rescue systems, immobilization devices), handheld surgical instruments, and reusable surgical retractors. Class I devices are subject to the least regulatory control and do not require a conformity assessment by a Notified Body, except when they have a measuring function or are sterile.
• Class IIa and Class IIb Devices: Class II devices are medium risk. Class IIa devices might include dental fillings and sutures, ventilators, suction units, whereas Class IIb are generally considered higher risk under Class II, including blood bags and infusion pumps. These devices require more stringent conformity assessments involving a Notified Body to ensure compliance with the essential requirements.
• Class III Devices: These are the highest risk devices and include items such as heart valves, implantable defibrillators, and breast implants. Class III devices are subject to the highest level of regulatory scrutiny to ensure their safety and effectiveness. The conformity assessment for these devices includes a detailed examination of the manufacturing process and ongoing evaluations.

 

Under the new MDR, the classification rules have been updated and expanded to include more detailed consideration of specific device features like whether the device is invasive or implantable, incorporates a medicinal substance, or is intended to be used for more than 30 days. These factors contribute to a more precise classification and tailored regulatory oversight.

The regulation mandates adherence to new common technical specifications set by the European Commission or a designated panel of experts. These specifications must be considered alongside existing Harmonised Standards and the current state of the art, elevating the requirements for compliance.

Under the new Medical Device Regulation (MDR), the role and responsibilities of manufacturers have been significantly expanded to ensure higher standards of safety and efficacy for medical devices within the European Union. This enhanced role requires manufacturers to undertake comprehensive measures throughout the lifecycle of each device, from design to post-market surveillance.

Manufacturers like Spencer must now demonstrate that their medical devices are designed and manufactured in accordance with the stringent requirements of the MDR. This includes proving through detailed documentation and testing that each device complies with the relevant safety and performance specifications. This obligation ensures that every device placed on the market has been rigorously evaluated for safety and efficacy, reducing the risk of adverse events and improving patient outcomes.

Under the new Medical Device Regulation (MDR), there is an enhanced emphasis on accountability and expertise within manufacturing organizations. Manufacturers are now required to appoint at least one Qualified Person (QP) who holds the responsibility for ensuring regulatory compliance of their medical devices. This requirement underscores the importance of having skilled personnel who can manage the complex regulatory landscape effectively.

The role of the Qualified Person is pivotal in navigating the regulatory requirements set forth by the MDR. The QP is responsible for the oversight of all aspects of the quality management system, from device conception through design, manufacturing, market release, and post-market surveillance. This individual serves as a key point of contact between the manufacturer and regulatory authorities, ensuring that all communication and reporting obligations are met accurately and on time.

The MDR specifies that the Qualified Person must have formal qualifications and a minimum number of years of professional experience in the field of medical devices. The QP is also tasked with maintaining the documentation and records necessary to demonstrate compliance, such as technical documentation, declarations of conformity, and compliance with the UDI system.

The implementation of the Unique Device Identification (UDI) system under the new Medical Device Regulation (MDR) represents a significant advancement in the traceability and safety management of medical devices throughout the European Union. This system requires that each medical device marketed in the EU is assigned a distinct UDI, a globally unique code that accompanies the device throughout its market life. This UDI is essential for enhancing the transparency and accountability of medical devices.

The UDI itself is comprised of two parts:

• the Device Identifier (DI) which denotes the specific model of the device and the manufacturer,
• the Production Identifier (PI) which provides information related to the production of the device, such as the batch number, serial number, expiration date, and manufacturing date. This information is crucial as it helps to precisely identify and track medical devices.

 

The primary benefit of the UDI system is improved traceability. Having a unique identifier for each device allows healthcare providers, patients, manufacturers, and regulatory bodies to track the device from manufacturing through to end use. This enhanced traceability is crucial not only for routine tracking but also for effectively managing critical situations such as recalls. In the event of a recall, the UDI allows for swift identification of affected devices, ensuring they can be quickly located and removed from circulation if necessary.

Under the MDR, manufacturers like Spencer are required to provide comprehensive clinical evidence for each device they intend to market. This evidence must demonstrate through clinical evaluations and, if necessary, clinical investigations, that their devices are consistently safe and perform as intended. The level of evidence required varies based on the device’s classification, with higher-risk devices subject to more stringent evaluations.

For many devices, particularly those that are new or have been significantly modified, existing clinical data may not be sufficient to meet the new standards. In such cases, we at Spencer have been required to conduct clinical investigations to gather new data. These studies are designed to assess the safety and performance of the devices in real-world medical settings, providing robust evidence that supports their market approval.

The MDR also imposes an ongoing obligation on manufacturers to regularly update their clinical evidence. This means that our organization must continuously monitor and gather data on the performance and safety of its devices post-market. This is achieved through various means, such as post-market clinical follow-up studies, customer feedback, and the monitoring of adverse event reports.

Systematic clinical evaluation under the MDR involves a continuous and rigorous assessment process to ensure that medical devices comply with current safety and performance standards. Manufacturers are required to regularly review and update their clinical evaluations based on new scientific findings and feedback from actual device usage. This ongoing process helps identify potential safety issues and efficacy concerns, ensuring that devices remain effective and safe throughout their lifecycle. The systematic approach ensures that medical devices continue to meet the high standards expected in the ever-evolving medical field.

Under the new Medical Device Regulation (MDR), the authority of Notified Bodies has been significantly strengthened to ensure the ongoing compliance and safety of medical devices after they have entered the market. These enhanced powers include the ability to conduct unannounced audits of manufacturing facilities, which serves as a powerful deterrent against non-compliance and helps maintain consistent adherence to regulatory standards. Additionally, Notified Bodies can now perform more thorough product sample checks and execute detailed testing of the devices. This level of rigorous oversight is crucial for detecting any deviations from safety standards or performance specifications that might not be apparent during the initial certification process.

The increased post-market surveillance activities by Notified Bodies help in identifying and addressing potential risks associated with medical devices at an early stage. This proactive approach ensures that any issues can be rectified promptly, thereby safeguarding public health and maintaining the trust of consumers and healthcare professionals in the safety and efficacy of medical devices available on the market.

Distributors are now required to implement comprehensive quality management systems that align with the MDR’s strict standards. These systems are crucial for ensuring that all aspects of the distribution process—from storage and handling to the final delivery of medical devices—are conducted in a manner that maintains the integrity and efficacy of the products.

In addition to establishing quality management systems, distributors must also conduct regular sample inspections of the medical devices they distribute. This involves periodically selecting samples from their inventory and assessing them for compliance with regulatory standards and performance criteria. These inspections help to identify any deviations from specified quality standards or potential safety issues before the products reach healthcare providers and patients.

This heightened involvement of distributors is designed to reinforce the overall safety net of the medical device market, ensuring that all entities involved in the supply chain contribute to the continuous safety and compliance of medical devices. These measures not only protect public health but also enhance the accountability and reliability of the distribution network in the medical device industry.

• 26/05/2021: All Class I medical devices must comply with the MDR. Certificates issued under the old Directive can remain valid for up to four additional years, depending on the device.
• 27/05/2024: Certificates issued under the old Directive are no longer valid.
• 27/05/2025: Devices certified under the old Directive can no longer be sold or distributed.

As a proactive manufacturer committed to compliance and excellence, Spencer has implemented comprehensive strategies to ensure that all its products fully adhere to the stringent requirements of the new Medical Device Regulation (MDR).

1. Strengthening R&D Capabilities: Spencer has significantly invested in its research and development (R&D) capabilities, enhancing the design and testing of its medical devices. This strategic enhancement includes the establishment of dedicated teams focused on clinical research and data analysis, ensuring that our innovations align with cutting-edge medical needs and regulatory expectations.

2. Establishing Robust Clinical Trials: To validate the safety and efficacy of our devices, Spencer conducts controlled clinical trials. These trials are meticulously designed to generate valid and reliable data, complying with both global standards and specific regulatory requirements. This rigorous approach to clinical trials ensures that our products are not only effective but also secure for patient use.

3. Enhancing Data Management Systems: Recognizing the critical role of data in proving compliance and enhancing device safety, Spencer has implemented advanced data management systems. These systems manage the extensive data collected from clinical trials and post-market surveillance, ensuring accurate recording, processing, and easy accessibility for ongoing analysis and regulatory review.

4. Continuous Training: Spencer is committed to continuous professional development, ensuring that all staff, especially those involved in regulatory processes, are well-trained in the latest requirements and clinical evaluation procedures. This includes specialized training for the Qualified Person responsible for regulatory compliance, keeping our team at the forefront of regulatory excellence.

5. Engaging with Regulatory Bodies: To maintain transparency and compliance, Spencer actively engages with regulatory authorities. This engagement includes regular pre-submission meetings and updates about ongoing clinical studies, ensuring that all clinical evaluations and documentation align with current regulatory standards.

 

Through these strategic initiatives, Spencer not only ensures compliance with the new MDR but also reinforces its position as a leader in the medical device industry, dedicated to providing products that are safe, effective, and of the highest quality. This comprehensive approach not only satisfies regulatory demands but also builds trust with healthcare providers and patients, securing a safer future for medical device applications.

The new EU Medical Device Regulation (MDR) marks a pivotal transformation in the regulation of medical devices within the European Union, significantly enhancing the standards for patient safety and device effectiveness. This regulation not only impacts manufacturers but also places a new emphasis on the role of distributors, who are now required to meet more stringent compliance and oversight obligations.

Distributors are integral to the medical device supply chain, and the MDR mandates that they implement robust quality management systems and engage in meticulous sample inspections to ensure that the devices they distribute consistently meet the highest standards of safety and effectiveness. These responsibilities highlight the importance of distributors in maintaining the integrity of medical devices from the point of manufacture to delivery to healthcare providers.

The MDR’s comprehensive approach elevates the benchmarks for all stakeholders involved in the medical device lifecycle—manufacturers, distributors, and healthcare providers alike—ensuring that everyone contributes to the safety and efficacy of medical devices. This collaborative effort not only protects patients but also reinforces the quality of healthcare across Europe.

For stakeholders looking to navigate these changes or understand their specific implications, we invite you to get in touch with us for more detailed information and guidance. By choosing to partner with compliant and certified manufacturers like Spencer, distributors can assure healthcare providers and patients of their commitment to distributing top-quality medical devices, thus enhancing healthcare outcomes throughout the continent. This strategic alignment with the MDR’s standards is crucial for maintaining trust and ensuring the continued well-being of patients across the EU.

 

Author: Domenico Panetta, Head of Marketing and Communication