Says that the document on ‘essential principle for safety and performance of medical device’ is inline with international practices
Association of Indian Medical Device Industry (AIMED) welcomed the health ministry’s initiative to document the guidance for use in manufacturing of medical devices which intended to be sold in India. Recently, the health ministry had invited comments and suggestions from the medical devices manufacturers and medical devices association on draft guidance document on essential principles for safety and performance of medical devices. It is covered under rule 6 of Medical Devices, 2017 which will be implemented from January 1, 2018. AIMED also found the draft guidance document to be in line with current requirements.
Rajiv Nath, Forum Co-ordinator, AIMED said that the draft guidance document is in line with international best practices for regulating medical devices. He also said that it is the correct approach as innovative medical devices do not always have product standards but quality safety and performance needs to be proven by other essential principles to mitigate any risk to patients.
The document provides an overview on meeting the essential principles for safety and performance of medical devices. However, it does not dictate how a manufacturer should prove that their medical device has met the essential principles laid down in this document, hence providing flexibility to the manufacturers and catering to technological advances and changes in the development of new medical devices.
The draft document describes fundamental design and manufacturing requirements, referred to as ‘Essential Principles for Safety and Performance’ that, when met, indicate a medical device including in vitro diagnostic medical device is safe and performs to its specification.
Seven general requirements of safety and performance that apply to all medical devices including IVD medical devices.
- Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and, where applicable, by virtue of the technical knowledge, experience, education or training, and the medical and physical conditions of intended users, they will perform as intended by the manufacturer and not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
- The solutions adopted by the manufacturer for the design and manufacture of the devices should conform to safety principles, taking account of the generally acknowledged state of the art. When risk(s) reduction is required, the manufacturer should control the risk(s) so that the residual risk associated with each hazard is judged acceptable. The manufacturer should apply the following principles in the priority order listed:
- identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;
- eliminate risks as far as reasonably practicable through inherently safe design and manufacture;
- reduce as far as reasonably practicable the remaining risks by taking adequate protection measures, including alarms; and
- inform users of any residual risks.
- Medical devices should achieve the performance intended by the manufacturer and be designed, manufactured and packaged in such a way that, during normal conditions of use, they are suitable for their intended purpose.
- The characteristics and performances referred to in above clauses should not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during Guidance Document on Medical Devices MoHFW, Government of India July, 2017 Page 7 of 27 the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer‟s instructions.
- Medical devices should be designed, 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 (for example, fluctuations of temperature and humidity) taking account of the instructions and information provided by the manufacturer.
- All known and foreseeable risks, and any undesirable effects, should be minimised and be acceptable when weighed against the benefits of the intended performance of medical devices during normal conditions of use.
- Every medical device requires clinical evidence, appropriate for its intended use and classification of the medical device, demonstrating that the device complies with the applicable provisions of the essential principles.
Apart from the seven general requirements of safety and performance that apply to all medical devices including IVD medical devices, the manufacturer can select which of the design and manufacturing requirements are relevant to a particular medical device, documenting the reasons for excluding the other guidance mentioned in the document. The manufacturer shall retain or be able to provide documentation to demonstrate that the device conforms to the selected standard or alternative means of meeting the Essential Principles.