Today, we will move on to discuss the second part of the topic on Essential Principles and why product owners have to pay attention to them. If you have missed out on part one of the article where we discuss on the first seven general requirements, please click here!
In this part two of the article, we will go in straight to discuss the other eleven requirements where they revolve around the design and manufacturing of your device. We have summarised them to keep the article concise, instead of listing all the sub-clauses. If you need to refer to the actual essential principles checklist published by HSA Singapore, you can download it here (GN- 16 Essential Principle Checklist Template).
In general, some of these requirements may not be applicable to your medical devices; depending on the nature of it. In such cases, proper justification must be provided to demonstrate non-applicability.
Design and Manufacturing Requirements
8- Chemical, physical and biological properties
When we start to discuss about the chemical, physical and biological properties of the medical device, we often spoke about the choice of material used, its biocompatibility status, duration of exposure to human body, possibility of leeching, ingress and egress of substances.
If you are working with medical devices such as drug-eluting stent and antibiotic bone cements, this section becomes especially important because of its long-term use within the patient.
9- Infection and microbial contamination
The devices and manufacturing processes should be designed in such a way as to eliminate or to reduce risk of contamination and infection to patients or users. When your medical device needs to be supplied either in a special microbiological state, sterile state or non-sterile state, validation data must be provided that the level of sterility or cleanliness is maintained. This clause is also important for devices that contain tissues, tissue derivatives, cells and other substances where any transmissible agents should be eliminated or inactivated during the manufacturing processes.
10- Manufacturing and environmental properties
Devices should be designed and manufactured in such a way as to remove or reduce foreseeable risk when used with another medical device or equipment. Any restrictions to the combined use of the device with others must be indicated in the instructions for use. Physical and environmental (humidity, temperature) hazards must be part of the evaluation. Finally, the design must also take into considerations for safe disposal of medical device.
11- Devices with a diagnostic or measuring function
This clause applies in relation to medical devices with diagnostic and measuring function. Accuracy, precision, sensitivity, specificity, limit of detection are few of the parameters that needs to be addressed in this clause. When the use of calibrators/control materials is involved, the traceability of the values assigned to such agents should also be assured.
12- Protection against radiation
This clause applies in relation to medical devices that emit ionising radiation. Device should be designed, manufactured and packaged in a way that exposure of patients, users and other persons to any emitted radiation should be reduced, while not restricting the application of the device. Instructions should also be provided to safeguard users and patients throughout the use of the device. One very good example is an x-ray machine.
13- Medical devices connected to or equipped with an energy source
This clause applies to medical devices that incorporate electronic programmable system, including software. It is important to address safety issue as part of risk analysis and indicate what control measures are in place to reduce the risk relating to electrical safety and electromagnetic compatibility. Information is to be provided regarding the power supply (internal or external) used and alarms (if any). IEC 60601, IEC 61010, IEC 61326 series and FCC are usually the few standards used to demonstrate compliance.
14- Protection against mechanical risks
Devices should be designed and manufactured in such a way as to protect the patient and user against mechanical risks and risk arising from vibration and noise emitted by the device. Some examples are drills and dental hand pieces.
15- Protection against the risks posed to the patient by supplied energy or substances
This clause applies to medical device that supply patient with energy or substances for therapeutic purposes. The device should be designed and manufactured in a manner such that the energy level exposed is guaranteed safe for patients and users, with sufficient instructions for operation purposes. Phototherapy device for jaundiced babies is one example here.
16- Protection against the risks posed to the patient for devices for self-testing or self- administration
This clause applies to medical device that are intended for self-testing or self-administration. It is important that the information and instructions provided by the product owner should be easy for the user to understand and apply. Usability considerations are also key to ensure safety and performance of device because the patients and users are lay person and not professionally trained. Such examples are pregnancy test kits and blood pressure monitor.
17- Information supplied by the product owner
Users should be provided with the information needed to identify the product owner, to use the device safely and to ensure the intended performance, taking account of their training and knowledge. This could be in the form of labeling and documentation such as product inserts and manuals.
18- Clinical Investigation
Clinical investigations on human subjects should be carried out in accordance with the principles of the Helsinki Declaration. The ISO 14155 is one standard that you can refer as it addresses the good clinical practice for clinical investigations of medical devices on human subjects.
Clauses 8 to 18 are provided as an overview for your basic understanding of each requirement. For a complete guidance, please refer to GN-16-R1.1 Guidance on Essential Principles for Safety and Performance of Medical Devices as published by HSA, Singapore.
Different countries have slightly different versions of the essential principles. Some countries have additional clauses for IVD devices. It is important to get hold of the checklist for the market that you are entering, so you can plan the method of compliance early in the design and development phase of your product. Singapore HSA accepts the EU and Australian TGA checklists, apart from the Singapore’s version. The ASEAN Medical Device Directive also published a version very similar to what Singapore has. Thus, the Singapore checklist will serve a very good example as to how the other ASEAN countries might adopt them.
Remember to consider these requirements early in your design and development plan to prevent any rework later on!
Please contact us here should you need our help to develop a regulatory strategy and analyse how much of the essential principles you have fulfilled for your medical device! Looking forward to hearing from you. Subscribe to us to receive more interesting content coming up!