Understanding the impact of the European Medical Device Regulation

In today's rapidly evolving healthcare landscape, medical devices play a crucial role in improving patient care, enhancing diagnostics, and revolutionizing treatment options. These innovative tools are transforming the way medical professionals diagnose, monitor, and treat various conditions, ultimately leading to better patient outcomes. However, the development and use of medical devices are closely regulated to ensure their safety, efficacy, and quality. By complying with these regulations, manufacturers and healthcare professionals can provide patients with the highest standards of care while fostering ongoing advancements in medical technology.

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The World Health Organization (WHO) defines a medical device as "any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes."¹ Essentially, medical devices encompass a wide range of tools and technologies designed to diagnose, prevent, monitor, or treat diseases or conditions in humans.

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Some examples of medical devices are:

1. Blood glucose monitors for diabetes management.
2. Magnetic resonance imaging (MRI) machines for detailed imaging of body structures.
3. Electrocardiogram (ECG) devices for recording heart activity.
4. Insulin pumps for delivering precise doses of insulin to individuals with diabetes.
5. Pacemakers to regulate abnormal heart rhythms.
6. Prosthetic limbs to assist individuals with limb loss.
7. Continuous glucose monitoring (CGM) systems for real-time tracking of blood sugar levels.
8. Blood pressure monitors for measuring and tracking blood pressure.
9. Pulse oximeters for measuring oxygen levels in the blood.

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Since 26th May 2021, medical devices in Europe are regulated by the Medical Device Regulation (EU) 2017/745 (MDR)², which replaces Directive 93/42/EEC on medical devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD). Consequently, manufacturers are required to comply with this regulation when introducing new medical devices to the market. This transition holds significant implications for medical device companies operating in the European market.

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The MDR document is more comprehensive and stringent compared to the original MDD. It places a strong emphasis on product safety and post-market surveillance, thereby improving safety and quality standards. Medical device companies must review their products and core processes, recertify existing products, and update technical documentation and labeling to meet the new standards. The increased focus on evidence-based practices and stricter requirements necessitates significant changes to technical documentation and quality management systems (QMSs).

Regarding transitional periods, the MDR has been recently amended by Regulation (EU) 2023/607^3,4, which introduces the following changes:

• The transition period for MDR compliance is extended until either 31st December 2027 or 31st December 2028, depending on the risk classification of the device.
• A transition period until 26th May 2026 is implemented specifically for class III custom-made implantable devices.

However, it is essential to note that the extension is subject to several conditions. These conditions ensure that only safe devices for which the manufacturer has initiated the MDR conformity assessment process by 26th May 2024 are eligible to benefit from the extended transition period.

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Transition from MDD to MDR - Key challenges

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The new regulations aim to enhance the safety and effectiveness of medical devices in the European market while addressing shortcomings identified in the implementation of the MDD. The main changes include:

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1. Expanded Scope and Classification of Products: A significant change lies in the classification rules for medical devices, leading to adjustments in risk classification. Specifically, the MDR introduces new classification rules for software as a medical device (SaMD), resulting in the up-classification of many software products. Companies must adhere to stricter regulations to ensure the safety and effectiveness of their software in the medical field.

2. Improved Product Traceability through UDI System: The MDR implements a Unique Device Identification (UDI) system to standardize the identification of medical devices and enhance traceability throughout the economic operator supply chain.

3. Enhanced Post-Market Surveillance and Vigilance: Unlike the primarily passive and reactive Post-Market Surveillance (PMS) system under the MDD, the EU MDR empowers notified bodies and competent authorities with increased authority for unannounced audits, sample checks, and annual safety reports. The EU MDR emphasizes the need for enhanced clinical evidence and proactive collection of PMS/PMCF (Post-Market Clinical Follow-up) data to evaluate the safety and performance of devices. The EU MDR requires the development of a PMS plan and a Periodic Safety Update Report (PSUR) for each device, device cluster, or device family. These requirements apply uniformly across all classes of medical devices. By implementing these changes, the EU MDR aims to establish a robust and proactive PMS system that facilitates a comprehensive benefit-risk evaluation of medical devices.

4. Roles of Economic Operators and Regulatory Compliance: Manufacturers must establish effective strategies and procedures to ensure ongoing regulatory compliance. This includes conducting clinical evaluations, identifying safety requirements, managing risk, and evaluating the clinical data of existing devices in the market. Manufacturers need to verify the adequacy and validity of the clinical data according to MDR standards and consider additional testing if necessary.

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Importance of compliance with EU MDR - Why is it needed?

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Although complying with the MDR may require significant effort, it brings several benefits. By adhering to the new regulations, medical device companies can strengthen their reputation, demonstrate a commitment to patient safety, and enhance market access within the EU. Furthermore, compliance with the MDR fosters harmonization and streamlines processes, facilitating trade and collaboration among member states.

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At Tucuvi, we are continuously pushing forward, generating clinical evidence to demonstrate the safety and effectiveness of our device. All our follow-up protocols or care processes are validated with clinical guidelines and evidenced by our medical product team following high-quality processes. 

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Our product, intended for the automation of clinical phone calls through conversational AI, is currently CE marked as Class I device according to MDD, but it will be up-classified as a Class IIa device according to the MDR. Therefore, we are currently in the transition period from MDD to MDR for our product. Tucuvi has already selected and been accepted by a Notified Body to collaborate on the certification of our product under the MDR, as well as our quality management system (QMS) for manufacturers of medical devices in accordance with ISO 13485.

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This next step brings us closer to the aim of providing a SaMD compliant with the latest regulations that ensures safety and effectiveness, increasing healthcare professionals' capacity in their daily work while providing high-value care for patients.

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Finally, it should be mentioned that Tucuvi is already working on implementing the requirements of the EU AI Act, which has been recently approved by the European Parliament. This comprehensive legislation aims to safeguard consumers from the potential risks posed by artificial intelligence applications.

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References:

1. World Health Organization (WHO). (2020). Medical devices. Retrieved from https://www.who.int/medical_devices/en/ 
2. European Commission. (2020). Medical devices. Retrieved from https://health.ec.europa.eu/medical-devices-sector_en 
3. Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023. Retrieved from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607
4. European Commission (March 2023). Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods. Retrieved from https://health.ec.europa.eu/latest-updates_en