Mdsap - essential principles checklist (tga)

Template Questions

• 1. Use of medical devices not to compromise health and safety
• A medical device is to be designed and produced in a way that ensures that:
• 1. GENERAL PRINCIPLES
• (b) any risks associated with the use of the device are:
• 2. Design and construction of medical devices to conform with safety principles
• (2) Without limiting subclause (1), in selecting appropriate solutions for the design and constructio
• (3) In paragraph 2 (d):
• 3. Medical devices to be suitable for intended purpose
• A medical device must:
• 4. Long-term safety
• A medical device must be designed and produced in a way that ensures that if:
• 5. Medical devices not to be adversely affected by transport or storage
• 6. Benefits of medical devices to outweigh any undesirable effects
• 7. Chemical, physical and biological properties
• 7.1 Choice of materials
• In ensuring that the requirements of Part 1 are met in relation to a medical device, particular atten
• 2. PRINCIPLES ABOUT DESIGN AND CONSTRUCTION
• 7.2 Minimisation of risks associated with contaminants and residues
• 7.3 Ability to be used safely with materials, etc
• (2) If the device is intended to be used to administer medicine, it must be designed and produced in
• 7.4 Verification of incorporated substance
• (1) If a medical device incorporates, or is intended to incorporate, as an integral part, a substance
• 7.5 Minimisation of risks associated with leaching substances
• 7.6 Minimisation of risks associated with ingress or egress of substances
• 8. Infection and microbial contamination
• 8.1 Minimisation of risk of infection and contamination
• (2) The device must be designed in a way that:
• 8.2 Control of animal, microbial or recombinant tissues, tissue derivatives, cells and other substanc
• (1) This clause applies in relation to a medical device that contains:
• 8.3 Medical devices to be supplied in a sterile state
• 8.4 Medical devices to be supplied in a non-sterile state
• (2) If the device is intended to be sterilised before it is used, the device must be packed in a way
• 8.5 Distinction between medical devices supplied in sterile and non-sterile state
• 9. Construction and environmental properties
• 9.1 Medical devices intended to be used in combination with other devices or equipment
• A medical device that is intended by the manufacturer to be used in combination with another medical
• 9.2 Minimisation of risks associated with use of medical devices
• A medical device must be designed and produced in a way that ensures that, as far as practicable, the
• (3) The measurements made by the device must be expressed:
• The operating instructions for a medical device that emits radiation must include detailed informatio
• A medical device that incorporates an electronic programmable system must be designed and produced in
• (2) The device must be designed and produced in a way that ensures that:
• (1) An active implantable medical device must incorporate, display, emit or exhibit a code or unique
• (1) The following information must be provided with a medical device:
• (2) In particular:
• (3) The information:
• (2) If it is not practicable to comply with subclause (1) in relation to the provision of the informa
• (9) If applicable, an indication that:
• Note: In addition to the information mentioned above, regulation 10.2 requires certain information to
• (2) However, instructions for use of a medical device need not be provided with the device, or may be
• (10) If applicable, an indication that:
• (12) For a device that is intended by the manufacturer to be supplied in a sterile state:
• (20) For a reusable device:
• (29) For an IVD medical device, information (including, to the extent practicable, drawings and diagr
• Note: See regulation 3.11 and the clinical evaluation procedures.
• Comments/Recommendations
• Name and signature