The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.
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The Egyptian Drug Authority (EDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to detecting and reporting adverse reactions to pharmaceutical products and medical devices.
The document provides an overview of the applicable regulatory requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance to it.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations, unless explicitly stated by the authority.
Furthermore, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the vigilance system introduced in Egypt for medical devices placed on the country’s market.
Medical Devices Vigilance System
First of all, the authority acknowledges the important role medical devices play in the healthcare sector. Their efficacy and safety are vitally important for the well-being of patients.
To ensure their safe and optimal functioning, it is necessary to have a robust vigilance system in place, especially once these devices are in the post-marketing phase.
The present guidance provides details on the concept, significance, classification, and operation of the Medical Devices Vigilance System.
Significance of Post-Marketing Vigilance
When medical devices are placed on the market, they carry with them data and insights from their pre-marketing phase.
However, this information is often not exhaustive, particularly concerning adverse incidents. There are two primary reasons for this:
- The pre-marketing review process cannot reasonably anticipate all potential device failures or incidents that might arise due to misuse in the post-marketing phase.
- It is only when the device is in actual use that unforeseen challenges related to its safety and performance emerge.
Furthermore, the authority also mentions that electrically active medical devices, like those monitoring patients or delivering therapy, require special attention.
They must be shown, through tests, scientific rationale, or validated simulations, to operate safely in an MR setting without interference.
Defining Medical Devices
It is important to mention that under the general rule, medical devices encompass a wide array of instruments and articles.
By definition, a medical device is any instrument, apparatus, software, implant, material, or other article meant for specific medical purposes. These purposes include:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of diseases.
- Diagnosis, monitoring, treatment, or compensation for injuries or disabilities.
- Investigation, modification, or replacement of the anatomy or physiological or pathological processes.
- Providing information through in vitro examination of specimens obtained from the human body, such as organs, blood, and tissues.
The authority also mentions that medical devices achieve their primary intended action not through pharmacological, immunological, or metabolic means in the human body, though they might be assisted by such methods.
Moreover, certain products are also considered medical devices.
These include devices meant for conception control and products designed explicitly for cleaning, disinfecting, or sterilizing devices.
Classification of Medical Devices
In accordance with the applicable legislation, medical devices are categorized based on multiple factors, including their intended use, inherent risks, duration of patient contact, degree of invasiveness, and the part of the body they affect. The classifications are:
- Class I;
- Class IIa;
- Class IIb; and
- Class III.
The Medical Device Vigilance System
The Medical Device Vigilance System was established under the medical device directives. Its primary objective is to mitigate risks to the safety of patients, users, and other stakeholders.
The system identifies medical device safety concerns through various channels, including:
- Reporting by manufacturers or health professionals.
- Issue identification and reporting by the public.
- Information sharing with other competent authorities.
The Vigilance System is intended to:
- Enhance the health and safety protection of patients, users, and others by minimizing the recurrence of similar adverse incidents.
- Allow competent authorities to oversee the manufacturers’ response to reported incidents effectively.
- Ensure swift and direct implementation of Field Safety Corrective Actions (FSCAs).
- Empower healthcare professionals and users responsible for medical device maintenance and safety to act promptly once a corrective measure is determined.
- Permit competent authorities to monitor devices of similar types, even if produced by various manufacturers.
The Medical Device Vigilance System achieves its goals through several mechanisms:
- Manufacturers and users submit vigilance reports to the appropriate competent authorities, such as the EDA.
- The competent authorities evaluate the reported incidents.
- This is followed by an active dissemination of information to prevent the repetition of the incident or mitigate its consequences.
- If deemed necessary, the device might undergo updates, modifications, or even removal from the market.
According to the guidance, vigilance concerns might originate from adverse incidents or field safety corrective actions.
Conclusion
In summary, the Medical Devices Vigilance System described in the guidance is a critical framework ensuring the safety and efficacy of medical devices in the post-marketing phase through continuous monitoring, evaluation, and corrective actions.
The present guidance provides an overview of the said system and highlights the key points associated thereto.
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