The new article addresses the aspects related to specific rules for medical devices with a measuring function or the ones intended to be sterile. The document also describes the general approach to be followed when applying classification rules.
Table of Contents
The South African Health Products Regulatory Authority (SAHPRA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the classification of medical devices intended to be marketed and used in the country. The document provides additional clarifications regarding the current classification rules, as well as recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance with the existing regulatory requirements. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidelines and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations.
The scope of the guidance covers, inter alia, device-specific classification rules to be applied with respect to various types of medical devices.
Medical Devices With a Measuring Function
First of all, the authority explains that the product is considered to have a measuring function in the case it is initially intended to:
- Measure quantitatively a physiological or anatomical parameter, or
- Measure a quantity or a qualifiable characteristic of energy, or
- Measure substances delivered to or removed from the human body.
The authority further outlines the requirements to be followed in order to ensure a medical device with a measuring function complies with the underlying legislation. In particular, the authority states that the measurements provided by the device should:
- Be displayed in units of measurement used in the country or recognized by the authority, or
- Be compared to at least one reference point compliant with the above statement, and
- Be accurate to enable the device to achieve its intended purpose.
The authority additionally emphasizes the importance of ensuring compliance with any and all the above-mentioned requirements.
Under the applicable regulations, medical device manufacturers intended to place their products with a measuring function on a country’s market should provide sufficient evidence supporting the claims with respect to the device’s performance and effectiveness, as well as demonstrating compliance with the applicable Essential Principles in general and number 10 in particular. In this respect, the authority refers to a separate guidance document dedicated to the Essential Principles of Safety and Performance for further guidance.
In case a product in question is a Class A medical device with a measuring function, its manufacturer will have to submit the abovementioned evidence of compliance with the applicable Essential Principles together with a Declaration of Conformity.
In order to assist medical device manufacturers in following the approach described herein above, the document also provides a table containing examples of different medical devices that have or have no measuring function. The products described in the table include, inter alia, a clinical thermometer that displays patient temperature in C, a medicine measuring cup with ml or defined units marked, and diagnostic electromyography.
Sterile Devices
Apart from the medical devices with a measuring function, the document also described medical devices intended to be supplied sterile in order to minimize the risk of infection and also describes the regulatory requirements these products are subject to under the existing regulatory framework. Under the general rule, such medical devices should be terminally sterilized to a Sterility Assurance Level (SAL) of at least 10-6, unless this is not possible due to device material incompatibility with the proposed sterilization process. Furthermore, the authority explicitly states that it is the responsibility of the manufacturer to determine the most appropriate method for achieving the required SAL for a particular device after due consideration of the design and construction of the device. According to the guidance, the most common methods used for the sterilization of medical devices are moist heat or steam, dry heat, ionizing radiation, ethylene oxide, and liquid chemical sterilization.
The authority also mentions that in case the device intended to be sterile cannot undergo terminal sterilization with its characteristics being affected, the entire manufacturing process could be conducted aseptically – for instance, by sterile filtration. It is stated that in such a way a SAL achieved could be lower in comparison to situations when terminal sterilization is applied.
As in the case of medical devices with a measuring function, medical devices indented to be sterile should comply with the relevant Essential Principles, while both the Declaration of Conformity and the appropriate evidence should be provided.
Application of Classification Rules: Key Points
In order to assist medical device manufacturers and other parties involved in interpreting and applying the existing classification rules in a proper way, the authority also provides additional clarifications and flowcharts outlining the key points to be considered in the context of the decision-making process.
First of all, the authority mentions that under the general rule, if more than one rule may apply, the one associated with a higher classification should be applied.
According to the document, the flowchart describing the classification process is comprised of the following main questions to be answered:
- Do the “Additional rules” apply?
- Is this a non-invasive device?
- Is this an active device?
Should the answer be “no” to all of the above questions, the product is presumably not a medical device, hence, should not be subject to regulation under the medical devices framework.
Additional questions to be considered include, inter alia, the following ones:
- Is [the device intended] for contraception or preventing sexually transmitted diseases;
- Is [the device intended] for disinfecting, cleaning, rinsing, or hydrating;
- Contains viable or non-viable animal tissues or derivatives.
In summary, the present SAHPRA guidance dedicated to medical device classification rules provides additional clarifications regarding the approach to be applied with respect to specific categories of medical devices, such as the ones with a measuring function or intended to be sterile. Apart from that, the document also outlines the key points to be taken into consideration when applying the classification rules set forth under the existing legislation.
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