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EP 9.1
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MDR GSPR 14.1
IVDR GSPR 13.1
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For all devices:
- Clarify that information on the label, or in the instructions for use, includes:
- any restrictions on combinations with other devices or equipment
- minimising risks of connections handled by the user, such as misconnection.
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NEW
EP 9.2 (a-c)
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MDR GSPR 14.2
IVDR GSPR 13.2
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For all devices:
- Clarify expectations through including equivalent examples to those in MDR/IVDR clauses (a)(b).
- Clarify the expectation, identified in MDR/IVDR (c), to remove or minimise risks associated with use of the device when it comes into contact with various materials, liquids and substances, when used as intended.
- Clarify the expectation, identified in MDR/IVDR (d), to remove or minimise risks associated with negative interactions between software and the IT environment the device operates within and interacts.
For IVDs devices (NEW):
- Remove or minimise risks associated with incorrect identification of specimens and erroneous results, including examples for clarity.
This requirement may be included under AUS Essential Principle 15 (IVDs only), depending on legislative structure.
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EP 9.2(g)
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MDR GSPR 14.3
IVDR GSPR 13.3
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For all devices:
- Include reference to devices intended to be used with explosive substances.
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NEW
EP 9.2(h)
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MDR GSPR 14.7
IVDR GSPR 13.6
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For all devices:
- Identify and test procedures to enable safe disposal of devices after use and any waste products.
- Identified and tested disposal procedures , for disposal of the device, and any related waste products, are to be documented in the instructions for use.*
*This requirement may be included under AUS Essential Principle 13 (information provided with the device).
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NEW
(No equivalent)
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MDR GSPR 14.4
IVDR GSPR 13.4
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For all devices:
- Require devices to be designed and manufactured to ensure adjustment, calibration, and maintenance can be done safely and effectively.
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NEW
(No equivalent)
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MDR GSPR 14.5
IVDR GSPR 13.5
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For all devices:
- Require devices intended to operate together with other devices or products to be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.
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NEW
(No equivalent)
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MDR GSPR 14.6
IVDR GSPR 13.7
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For all devices:
- Require any measurement, monitoring or display scale to be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.
EP 10(2) for medical devices with a measuring function is equivalent to the above, however this MDR & IVDR GSPR applies to all devices, not only "those with a measuring function".
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