Medical Device Design Regulations
Meeting the Essential Principles—Principles about design and constructionPrinciple 9 – Construction and Environmental Properties
Information & Training. | Medical Devices
9.1 Medical Device Design Regulations – 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 device or other equipment (including a connection system) must be designed and produced in a way that ensures that:
– the medical device, and any other device or equipment with which it is used, operate in a safe way; and
– the intended performance of the device, and any other device or equipment with which it is used, is not impaired.
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 >>>
9.1 Medical Device Design Regulations – Medical devices intended to be used in combination with other medical equipment
The work undertaken by the manufacturer could involve, but is not restricted to:
– well-reasoned and documented risk analysis considering all the other devices meant to be used for the intended purpose of the device
– documenting how the device is designed for use with other medical devices and evidence of appropriate testing procedures that demonstrate that the combination of medical devices allows all medical devices to operate safely and without any impairment to the intended performance
– addressing the use of the device in combination with another medical device as part of the clinical evidence
– providing all the information for the use of the device in combination with another medical device as a part of the Instructions for Use
– for medical electrical systems, IEC 60601-1-1[1] can provide further guidance, but is not a mandatory standard that must be used
Medical Device Design Regulations – A medical device must be designed and produced in a way that ensures that, as far as practicable, the following risks are removed or minimised:
– the risk of injury arising from the physical features of the device;
– any risks associated with reasonably foreseeable environmental conditions;
– the risk of reciprocal interference involving other devices that are normally used in an investigation or treatment of the kind for which the device is intended to be used;
– any risks arising if maintenance or calibration of the device is not possible;
– any risks associated with the ageing of materials used in the device;
– any risks associated with loss of accuracy of any measuring or control mechanism of the device;
– the risk of fire or explosion occurring during normal use of the device, and in the event of a single fault condition, especially if the device is intended to be exposed to flammable substances or substances that can cause combustion;
– the risks associated with disposal of any waste substances.
9.2 Medical Device Design Regulations – Minimization of risks associated with the use of medical devices
The design and production processes should take account of the outcomes or conclusions from a well-reasoned and documented risk analysis that has identified and analysed the significance of any of the listed foreseeable risks when the device is used.
For each risk, the analysis should list all potential causes and determine the probability and severity of their occurrence. Risk-mitigation strategies should then be examined and tested.
The most common way to demonstrate compliance with the Essential Principles is to meet a standard published by an Australian or International Standards Agency, a Pharmacopoeia, or a similar standard.
The work undertaken by the manufacturer could involve, but is not restricted to:
– a well-reasoned and documented risk analysis
– documented compliance or consideration of relevant product safety and performance standards
[1]IEC 60601-1-1 is a standard relating to medical electrical equipment and safety requirements for medical electrical systems.
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 >>>