Principle 13 – Medical Device Instructions for Use
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Medical Device Regulations – TGA AustraliaInformation to be provided with Medical Devices
Meeting the Essential Principles—Principles about design and construction
Therapeutic Goods (Medical Devices) Regulations 2002
Information to be provided with medical devices — general:
– The following information must be provided with a medical device: information identifying the device; information identifying the manufacturer of the device; information explaining how to use the device safely;having regard to the training and knowledge of potential users of the device.
– In particular: the information required by clause 13.3 must be provided with a medical device; and if instructions for use of the device are required under sub-clause 13.4, the information mentioned in sub-clause 13.4 (3) must be provided in those instructions.
– The information: must be provided in English; and may also be provided in any other language.
– The format, content and location of the information must be appropriate for the device and its intended purpose.
– Any number, letter, symbol, or letter or number in a symbol, used in the information must be legible and at least 1 millimetre high.
If a symbol or identification colour that is not included in a medical device standard is used in the information provided with the device, or in the instructions for use of the device, the meaning of the symbol or identification colour must be explained in the information provided with the device or the instructions for use of the device.
Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
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13.1 General information to be provided with a medical device
The work undertaken by the manufacturer could involve, but is not restricted to:– ensuring that the label, packaging, and Instructions for Use meet the information requirements
– copies of the label, packaging, and Instructions for Use should be kept with the documentation that a manufacturer assembles and maintains to demonstrate compliance with the Essential Principles.
Information to be provided with medical devices — location
Unless it is impracticable or inappropriate to do so, the information required to be provided with a medical device must be provided on the device itself. If it is not practicable to comply with subclause (1) in relation to the provision of the information, the information must be provided: on the packaging used for the device; or in the case of devices that are packaged together because individual packaging of the devices for supply is not practicable — on the outer packaging used for the devices. If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under subregulation 10.2 (1) or clause 13.3, the information must be provided on a leaflet supplied with the device.
If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under clause 13.4, the information must be provided in a printed document or using other appropriate media.
13.2 Location of information to be provided with a medical device
The work undertaken by the manufacturer could involve, but is not restricted to:– ensuring that the label, packaging and Instructions for Use meet the information requirements
– copies of the label, packaging and Instructions for Use should be kept with the documentation that a manufacturer assembles and maintains to demonstrate compliance with the Essential Principles.
Medical Device Instructions for Use – Information to be provided with medical devices — particular requirements
The information mentioned in the following table must be provided with a medical device.| Item | Information to be provided |
| 1 | The manufacturer’s name, or trading name, and address |
| 2 | The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used (if this information is not obvious) |
| 3 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging |
| 4 | Any particular handling or storage requirements applying to the device |
| 5 | Any warnings, restrictions, or precautions that should be taken, in relation to use of the device |
| 6 | Any special operating instructions for the use of the device |
| 7 | If applicable, an indication that the device is intended for a single use only |
| 8 | If applicable, an indication that the device has been custom-made for a particular individual and is intended for use only by that individual or health professional |
| 9 | If applicable, an indication that: a) if the device is a medical device other than an IVD medical device—the device is intended for pre-market clinical investigation; or b) if the device is an IVD medical device—the devices is intended for performance evaluation only |
| 10 | For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilise the device |
| 11 | The batch code, lot number or serial number of the device |
| 12 | If applicable, a statement of the date (expressed in a way that clearly identifies the month and year) up to when the device can be safely used |
| 13 | If the information provided with the device does not include the information mentioned in item 12 — a statement of the date of manufacture of the device (this may be included in the batch code, lot number or serial number of the device, provided the date is clearly identifiable) |
| 14 | If applicable, the words ‘for export only’ |
13.3 Medical Device Instructions for Use – Particular requirements
The work undertaken by the manufacturer could involve, but is not restricted to:– ensuring that the label, packaging, and Instructions for Use meet the information requirements
– copies of the label, packaging and Instructions for Use should be kept with the documentation that a manufacturer assembles and maintains to demonstrate compliance with the Essential Principles.
Instructions for use
– Instructions for the use of a medical device must be provided with the device.
– However, instructions for the use of a medical device need not be provided with the device, or may be abbreviated, if: the device is a Class I medical device, a Class IIa medical device or a Class 1 IVD medical device; and the device can be used safely for its intended purpose without instructions.
– Instructions for the use of a medical device must include information mentioned in the following table that is applicable to the device.
| Item | Information to be provided |
| 1 | The manufacturer’s name, or trading name, and address |
| 2 | The intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used |
| 3 | Information about any risk arising because of other equipment likely to be present when the device is being used for its intended purpose (for example, electrical interference from electro‑surgical devices or magnetic field interference from magnetic resonance imaging devices) |
| 4 | Information about the intended performance of the device and any undesirable side effects caused by use of the device |
| 5 | Any contra‑indications, warnings, restrictions, or precautions that may apply in relation to use of the device |
| 6 | Sufficient information to enable a user to identify the device, or if relevant, the contents of packaging |
| 7 | Any particular handling or storage requirements applying to the device |
| 8 | If applicable, an indication that the device is intended for a single use only |
| 9 | If applicable, an indication that the device has been custom-made for a particular individual and is intended for use only by that individual or health professional |
| 10 | If applicable, an indication that the device is intended to be used only for clinical or performance investigations before being supplied a) if the device is a medical device other than an IVD medical device — the device is intended for pre‑market clinical investigation; or b) if the device is an IVD medical device — the device is intended for performance evaluation only |
| 11 | For a sterile device, the word ‘STERILE’ and information about the method that was used to sterilize the device |
| 12 | For a device that is intended by the manufacturer to be supplied in a sterile state: a) an indication that the device is sterile; and b) information about what to do if sterile packaging is damaged; and c) if appropriate, instructions for re-sterilization of the device |
| 13 | For a medical device that is intended by the manufacturer to be sterilized before use — instructions for cleaning and sterilizing the device which, if followed, will ensure that the device continues to comply with the applicable provisions of the Essential Principles |
| 14 | Any special operating instructions for the use of the device |
| 15 | Information to enable the user to verify whether the device is properly installed and whether it can be operated safely and correctly, including details of calibration (if any) needed to ensure that the device operates properly and safely during its intended life |
| 16 | Information about the nature and frequency of regular and preventative maintenance of the device, including information about the replacement of consumable components of the device during its intended life |
| 17 | Information about any treatment or handling needed before the device can be used |
| 18 | For a device that is intended by the manufacturer to be installed with, or connected to, another medical device or other equipment so that the device can operate as required for its intended purpose — sufficient information about the device to enable the user to identify the appropriate other medical device or equipment that will ensure a safe combination |
| 19 | For an implantable medical device — information about any risks associated with its implantation |
| 20 | For a reusable device: a) information about the appropriate processes to allow reuse of the device (including information about cleaning, disinfection, packaging and, if appropriate, re-sterilization of the device); and b) an indication of the number of times the device may be safely reused |
| 21 | For a medical device that is intended by the manufacturer to emit radiation for medical purposes — details of the nature, type, intensity and distribution of the radiation emitted |
| 22 | Information about precautions that should be taken by a patient and the user if the performance of the device changes |
| 23 | Information about precautions that should be taken by a patient and the user if it is reasonably foreseeable that use of the device will result in the patient or user being exposed to adverse environmental conditions |
| 24 | Adequate information about any medicinal product that the device is designed to administer, including any limitations on the substances that may be administered using the device |
| 25 | Information about any medicine (including any stable derivative of human blood or blood plasma) that is incorporated, or is intended to be incorporated, into the device as an integral part of the device |
| 25A | For a medical device, other than an IVD medical device, information about any tissues, tissue derivatives, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin that are included in the device |
| 26 | Information about precautions that should be taken by a patient and the user if there are special or unusual risks associated with the disposal of the device |
| 27 | Information about the degree of accuracy claimed if the device has a measuring function |
| 28 | Information about any particular facilities required for use of the device or any particular training or qualifications required by the user of the device |
| 29 | For an IVD medical device , information (including, to the extent practicable, drawings and diagrams) about the following: a) the scientific principle (the ‘test principle’) on which the performance of the IVD medical device relies; b) specimen type, collection, handling and preparation; c) reagent description and any limitations (for example, use with a dedicated instrument only); d) assay procedure including calculations and interpretation of results; e) interfering substances and their effect on the performance of the assay; f) analytical performance characteristics, such as sensitivity, specificity, accuracy and precision; g) clinical performance characteristics, such as sensitivity and specificity; h) reference intervals, if appropriate; i) any precautions to be taken in relation to substances or materials that present a risk of infection |
13.4 Instructions for use
The work undertaken by the manufacturer could involve, but is not restricted to:– ensuring that the label, packaging and Instructions for Use meet the information requirements
– copies of the label, packaging and Instructions for Use should be kept with the documentation that a manufacturer assembles and maintains to demonstrate compliance with the Essential Principles.
Information & Training.
Medical Device:
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
- FDA Medical Device Classification. The FDA approach to Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
- Medical Device Software Validation.
- Medical Device Design Validation.
- Electronic Signature, Electronic Records.
- Life Cycle Approach to Validation.
- Risk Identification. Documentation. DHR’s. DMR’s.
- Etc. Etc. …
- Information & Training presentation >>>