A medical device is a product, device, material, equipment, article, or application intended for use in the diagnosis of a disorder or other conditions, or in the cure, mitigation, prevention, diagnosis, or treatment of disease or illness, for detecting, correcting, restoring, measuring and modifying the structure or function of the body for purpose of supporting or sustaining life.
An individual under the supervision of a healthcare provider gets benefited from the action of a medical device, the user of a medical device.
Manufacturer means the natural or legal person that provides medical devices with responsibility for the design, manufacture, packaging, and labeling of a device before it is placed on the market to make the medical device available for use, under his name or designed and manufactured on behalf of another person.
A manufacturer of a medical device has to follow various principles as it is expected to design and manufacture a product that is safe and performs as intended throughout its lifecycle.
Medical devices should be designed and produced in a way that it ensures that the devices will not compromise the clinical conditions or safety of a patient, or the safety and health of the user or any other person when the device is used on a patient under the conditions and for the purposes for which the device was intended and, if applicable, by a user with appropriate technical knowledge, experience, education or training.
Manufacturers should establish documents, implement and maintain a risk management system to ensure the ongoing safety, performance, and quality of the medical device by adopting the solutions for the design and construction of the device with safety principles, to minimize any risks the manufacturer must:
Firstly, identify hazards and associated risks arising from the use of the device for its intended purpose and foreseeable misuse of the device.
Secondly, eliminate, control, or reduce those risks.
Thirdly, if appropriate, ensure that adequate protection measures are taken, concerning any risks that cannot be eliminated and evaluate the impact of information from the production and postproduction phases, benefit-risk determination, and risk acceptability.
Fourth, inform users of any residual risks that may arise due to any shortcomings of the protection measures adopted and if necessary, amend control measures in line with the requirements.
Medical devices should be designed and manufactured and packaged in such a way that their characteristics and performances during their intended use will not be adversely affected by transport and storage conditions that are carried out taking account of the instructions and information provided by the manufacturer.
Long-term safety should be ensured.
The benefits of the devices must outweigh any side effects.
Medical devices should be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.
Medical devices intended to be sterilized should be manufactured in suitable environmental conditions.
Good Manufacturing Practices are also the principles followed during the manufacturing of the product by the manufacturers, a set of formal specifications or set of requirements designed to ensure that all medical devices released to the market are safe and effective which includes:
Before the product is manufactured it should be taken care that there are clearly defined specifications and operating procedures in place.
Has all staff been trained on quality-impacting procedures within the area?
Are there defined records management processes and storage controls in place?
On the manufacturing site, throughout the manufacturing process are their defined test and inspection points.
Everyone involved in making a product must be clear about their roles and responsibilities so that the chain of accountability is established throughout the organization.
There should be fully documented instructions for equipment calibration so that it always works as intended.
GMP records such as product master records, batch or manufacturing records, material control records, personnel records, training records, cleaning logs, etc. as keeping these records support the traceability of a product that allows non-conformance to be traced effortlessly.
Validating the work.
Executing planned and periodic audits.
It also helps to implement preventive actions and corrective actions if any deviation occurs.
A medical device that has a measuring function must be designed and delivered in a way that ensures that the device provides correct, precise, and stable measurements within the limits implied by the manufacturer and having regard for the intended purpose of the device.
Manufacturers should also see to it that reviewing customer feedback is taken to improve product quality.
Users should be provided with the information needed to identify the manufacturer and use the device safely.
Information provided should be easily understood and detailed information for labeling should be incorporated.
Information provided to the customer includes:
The manufacturer’s name, or trade name, and address.
The planned user of the device, and the kind of patient on whom the device is intended to be used.
Sufficient information to enable a user to identify the device, or if relevant, the contents of the packaging.
Any particular handling or storage requirements applying to the device.
Any cautions, restrictions on use, or precautions that should be taken, about the use of the device.
Any particular operating instructions for the use of the device.
If applicable, an indication that the device has been custom-made for a particular individual or health professional and is intended for use only by that individual or health professional.
For a medical device that is software, or that incorporates software, the current version number and current build number of the software must be accessible by, and identifiable to users of the device.
Manufacturers are the natural or legal person that provides medical devices with responsibility for the design, manufacture, packaging, and labeling of a device before it is placed on the market to make the medical device available for use, under his name or designed and manufactured on behalf of another person. They must follow various principles and implement good manufacturing practices that make the product safe and effective and help to maintain the reputation of the company.