Guidance on how to interpret "significant change" of a medical device: Abbreviations and definitions
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Abbreviations
- AI
- artificial intelligence
- AQL
- acceptance quality limit
- ASTM
- American Society for Testing and Materials
- CW
- continuous wave
- EO
- ethylene oxide
- IEC
- International Electrotechnical Commission
- ISO
- International Organization for Standardization
- IV
- intravenous
- IVDD/IVD
- in vitro diagnostic device/in vitro diagnostic
- MDR
- Medical Device Regulations
- ML
- machine learning
- MLMD
- machine learning medical device
- MR
- magnetic resonance
- OS
- operating system
- PCCP
- predetermined change control plan
- PICC
- peripherally inserted central catheter
- PTA
- percutaneous transluminal angioplasty
- PW
- pulsed wave
Definitions
- Contraindications
- Situations where the device should not be used because the risk of use clearly outweighs any reasonably foreseeable benefits.
- Control mechanism
- The means by which the action of a device is directed or the output of a device is regulated.
- Compatibility
- The ability of a device, when used with 1 or more other devices, to achieve the intended overall clinical purpose without requiring the user to modify or adapt any part of the combined devices.
- Design specifications
- A set of device characteristics that clearly state the technical and performance criteria that a medical device meets. They must be measurable or verifiable. For example, the design specifications of a medical device can describe a device's:
- properties, such as dimensions, weight, mass, form, configuration or materials
- performance (or functional) characteristics, such as accuracy, strength, force, flexibility or energy source and output level
- Facility
- A site that's involved in the manufacture or design and manufacture of a medical device.
- Operating principles
- The means by which a device produces or brings about an intended or appropriate effect whereby a device is able to have a certain influence on a person or its surroundings.
- Precautions
- Information that alerts the user to exercise special care for the safe and effective use of the device.
- Recall
- For a medical device that has been sold, any action taken by the manufacturer, importer or distributor of the device to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device may:
- be hazardous to health
- fail to conform to any claim made by the manufacturer or importer about its effectiveness, benefits, performance characteristics or safety or
- not meet the requirements of the Food and Drugs Actor the Medical Devices Regulations
(MDR)
- Significant change
- A change that could reasonably be expected to affect the safety or effectiveness of a medical device. It includes a change to any of the following:
- manufacturing process, facility or equipment
- manufacturing quality control procedures, including the methods, tests or procedures used to control the quality, purity and sterility of the device or of the materials used in its manufacture
- design of the device, including its performance characteristics, principles of operation, specifications of materials, energy source, software or accessories
- intended use of the device, including any new or extended use, any addition or deletion of a contraindication for the device and any change to the period used to establish its expiry date
(MDR)
- Surgically invasive device
-
An invasive device that is intended to enter the body through an artificially created opening that provides access to body structures and fluids.
(MDR)
- Validation
-
Confirmation by examination and the provision of objective evidence that the requirements for a specific intended use have been fulfilled, as set out in the definition validation in section 2.18 of International Organization for Standardization standard ISO 8402:1994, Quality management and quality assurance.
(MDR)
- Verification
- Confirmation through provision of objective evidence that specified requirements (for example, comparing a new design specification with a similar proven design) have been fulfilled. Verification ensures a device performs as intended.
- Warning
- Describes serious adverse reactions and potential safety hazards that can occur in the proper use, or misuse, of a device, along with the consequent limitations in use and mitigating steps to take if they occur.