Medical Device Software Regulation – MHRA...

Information & Training. | Medical Devices.

Stand-alone software is software which has a medical purpose and at the time of it being placed onto the market is not incorporated into another medical device. The following details the approach by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency).

The intended purpose of the software is critical, as the software will only be regulated in relation to the intended medical purpose. Per the European Medical Device Directive (93/42/EEC) , a medical device is defined as … “software” (in this discussion)…. which is intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement or modification of the anatomy or of a physiological process,
• control of conception….”

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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Medical Device Software Regulation – Medical Device combination systems which include software.
Where a combination of CE marked medical devices and non-CE marked products are placed on the market, the MHRA will only regulate the individual devices which are to be CE marked (per the applicable EU Device Directives) and will not regulate the non CE marked devices, unless the combination of CE and non-CE marked devices are placed on the marked as a single product. The example of this approach is as follows:
Combining a laptop (which is not a medical device), with software to be used with the laptop (which is a medical device) and heart monitoring hardware (which would be considered an accessory). In this instance if marketed as a single product the full combination would be considered a medical device system and would need to comply with the relevant medical device directive.

Medical Device Software Regulation – Placing standalone software onto the European Market.
Where stand alone software is considered to be a medical device, then the persons placing onto the European market will be required to have in place a post market surveillance and adverse incident reporting processes. Additionally, the software will need to be fully validated, and will need clear comprehensive instructions for use (IFU’s). As normal the software will need to comply with the Essential Requirements of the relevant Medical Device Directive.

Medical Device software within a mobile phone.
Mobile medical apps which meet the definition of a medical device will be regulated by the MHRA as medical devices and will be required to undergo and comply with the various conformity assessment requirements.

The designer and manufacturer of the software will need to consider how antivirus protection may need to be incorporated into a mobile phone, if it is to be used as a medical device, as attack by software virus may compromise the integrity of the medical device application.
Where a manufacturer places a disclaimer on the mobile app, yet still markets as a medical device, then the manufacturer (or person placing onto the EU / EFTA Market) will still need to fully comply with the EU Directives (example of a disclaimer may be “for reference use only”)

EC Commission guidance on medical device software classification.
The European Commission has published a set of guidelines, titled “Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices”, these can be found under the MEDDEV 2.1/6 document, published January 2012. These give specific guidance in a step by step flow guide towards classification of stand alone software in terms of it being a medical device.

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 >>>

Reference sources:
MHRA – Medicines and Healthcare Products Regulatory Agency