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NEW
(No equivalent)
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MDR GSPR 18.1
IVDR GSPR 17.1
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For all devices:
- Clarify that non-implantable active devices (MDR GSPR 18.1) and devices connected to or equipped with a power supply (IVDR GSPR 17.1) are to minimise risk in the event of a single fault condition.
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NEW
EP 12.2
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MDR GSPR 18.2
IVDR GSPR 17.2
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For all devices:
- Require an appropriate warning or indication for when the capacity of the power supply becomes critical.
- If necessary, such warning or indication shall be given prior to the power supply becoming critical.
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NEW
EP 12.5
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MDR GSPR 18.5
IVDR GSPR 17.3
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For all devices:
- Require devices to be designed and manufactured to minimise risks of creating an electromagnetic field/interference that could impair not only other equipment, but also the device itself.
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NEW
(No equivalent)
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MDR GSPR 18.6
IVDR GSPR 17.4
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For all devices:
- Require devices to be designed and manufactured to provide a level of intrinsic immunity to electromagnetic interference.
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NEW
EP 12.7
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MDR GSPR 20.1
IVDR 18.1-2
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For non-IVD devices:
- Increase clarity through examples, such as, but not limited to, resistance to movement, instability and moving parts.
For IVD device (NEW):
- Require devices to be sufficiently stable under the foreseen operating conditions, including being suitable to:
- withstand stresses inherent to the foreseen working environment
- retain this resistance during the expected lifetime of the devices, subject to any inspection and maintenance requirements as indicated by the manufacturer.
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NEW
(No equivalent)
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IVDR GSPR 18.3
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For IVD devices:
- Require devices to include appropriate protections from any risks due to:
- moving parts
- break-up or detachment
- leakage of substances
- Require devices that incorporate any guards or other means of protection, in particular against moving parts, to be secure and not interfere with access for the normal operation of the device or restrict routine maintenance of the device as intended by the manufacturer.
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NEW
(No equivalent)
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MDR GSPR 20.5
IVDR GSPR 18.7
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For all devcies:
- Require errors when fitting and refitting parts, which could be a source of risk, to be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.
- Require the same information to be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.
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NEW
EP 12.13
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MDR GSPR 19.1
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For non-IVD devices:
Require active implantable devices to be designed and manufactured in such a way as to remove or minimize as far as possible:
- risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
- risks connected with medical treatment, in particular those resulting from the use of defibrillators or high- frequency surgical equipment, and
- risks which may arise where maintenance and calibration are impossible, including
- excessive increase of leakage currents
- ageing of the materials used
- excess heat generated by the device
- decreased accuracy of any measuring or control mechanism.
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NEW
EP 12.13
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MDR GSPR 19.2
|
For non-IVD devices:
Require active implantable devices to be designed and manufactured in such a way as to ensure:
- if applicable, the compatibility of the devices with the substances they are intended to administer, and
- the reliability of the source of energy.
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NEW
EP 12.13
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MDR GSPR 19.3
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For non-IVD devices:
- Require active implantable devices and, if appropriate, their component parts to be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component part
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