Device surveillance the European Union’s Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance.

Device surveillance The Medical Device Coordination Group (MDCG) has recently issued an updated version of its Surveillance Guidance for Medical Devices, bringing it in line with the transitional provisions outlined in EU regulations concerning medical devices and in vitro diagnostic devices (IVDs). This updated guidance holds significant importance for manufacturers, notified bodies, and regulatory authorities, as it underscores the importance of thorough post-market surveillance (PMS) and vigilance efforts to uphold device safety and efficacy.

“Legacy Devices: Device surveillance

These medical devices received approval under prior regulations and persist in the market despite the implementation of updated regulatory standards.

Surveillance: Device surveillance

This denotes the structured procedure of ongoing monitoring of medical device performance and safety subsequent to their introduction into the market. This process encompasses tasks such as gathering data regarding device functionality, scrutinizing incident reports, and executing remedial measures as required.”

The updated guidance places emphasis on various crucial aspects to improve the monitoring of medical devices within the EU. It delineates the duties and obligations of manufacturers, importers, distributors, and notified bodies, stressing the necessity of a proactive stance towards Post-Market Surveillance (PMS).

This document provides a framework for the tasks assigned to notified bodies as outlined in Article 120(3e) of the Medical Device Regulation (MDR). Alongside elucidating the verification requirements for notified bodies, it also sheds light on the responsibilities imposed on manufacturers, particularly regarding the management of their quality systems.

Surveillance protocols are only relevant to devices possessing MDD or AIMDD certificates. Those exempt from notified body oversight under MDD, as outlined in Article 120, are not subject to surveillance, even if MDR mandates it. As of September 25, 2024, in the absence of notified bodies designated under MDR issuing MDD or AIMDD certificates, surveillance obligations cease. Subsequently, responsibility transitions to the notified body with which the manufacturer holds an MDR certification arrangement.

Based on the manufacturer’s specifications, the notified body must ascertain:

• The utilization of current MDD or AIMDD certificates for device placement on the market or their activation for service.
• Confirmation of whether their scopes have remained consistent.
• Identification of the devices encompassed by these certificates.
• Determination of devices covered by the formal application(s) as outlined in Article 120(3c), point (e) of the MDR.

Furthermore, it is imperative for the notified body to guarantee the preservation of their rights and responsibilities in their capacity as the notified body, even amidst any changes in their status.

Adhering to the updated guidelines, manufacturers can uphold the safety and effectiveness of their medical devices, thereby safeguarding patient well-being and elevating the standard of healthcare provided. For a comprehensive grasp of the revised directives, please consult the complete document accessible.

Ensuring the continuity of rights and responsibilities for notified bodies amidst any transitions is crucial for maintaining regulatory compliance and upholding standards in the medical device industry. Notified bodies play a pivotal role in assessing the conformity of medical devices with relevant regulations and standards before they are placed on the market. Any changes in their status could potentially disrupt this process, leading to uncertainties for manufacturers and compromising patient safety.

By upholding their rights and duties, notified bodies can continue to provide essential services to manufacturers, offering expert assessment and certification of medical devices. This consistency is essential for manufacturers to navigate regulatory requirements effectively and ensure that their products meet the necessary safety and efficacy standards.

Manufacturers, on the other hand, have a responsibility to adhere to the guidance provided by notified bodies to ensure that their devices are safe and effective for use by patients. Following the revised guidance meticulously enables manufacturers to address any potential risks associated with their products and implement necessary measures to mitigate these risks.mdcg_2022-4_en

Ultimately, the goal of this process is to safeguard patient health and enhance the overall quality of care. By maintaining clear and consistent communication between notified bodies and manufacturers, and by adhering to updated guidelines, stakeholders can work together to achieve this goal while ensuring compliance with regulatory requirements. This collaborative effort is essential for maintaining public trust in the safety and effectiveness of medical devices.