Software as a Medical Device Flashcards
(14 cards)
When does a medical device used in the UK not require to be CE marked?
In-house SaMD which is not intended for commercial use.
If it is UKCA marked.
What is the definition of a Medical Device under the Medical Device Directive?
Medical devices are intended to be used for:
- Diagnosis, prevention, monitoring, treatment, 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 contraception
Excludes research-use only products and non-commercial in-house manufacture
What is software?
A computer program (compiled or un-compiled if instructions are available to compile it) or functional document (e.g. PDF with flow charts, spreadsheets, macros)
What are IV MDs?
In vitro diagnostic medical devices - a subset of MDs intended for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information
Are disclaimers from the manufacturer stating “not a medical device” acceptable if medical claims are made or implied?
No
What are the regulations around medical devices?
UK MDR 2002
Medical Device Regulations 2002, with guidance and support available for adherence
How is conformity to MDR assessed?
Class I (low risk) manufacturers self-certify with a “Declaration of Conformity”
High risk MDs are assessed by a notified body who produce a certificate, the assessment route differs depending on the type of the device. UKCA mark can then be used
What is an example of an MD notified body in the UK?
BSI
What are the MDR requirements for safety and effectiveness?
- Design - rules for risks and management
- Evidence collection - clinical evaluation
- Registration - with MHRA
- Post-market surveillance - throughout lifetime, gathering data on quality and trends, reporting to MHRA
Which class of medical device would stand-alone software intended for monitoring of
physiological parameters be categorised as?
Class II(a)
What is a Class I SaMD?
Class I
Software that is not intended to provide information used for diagnostic or therapeutic decisions.
Wellness apps, admin software
What is a Class IIa SaMD?
Class IIa
Software intended to provide information used to make decisions for diagnostic or therapeutic purposes.
Software that helps plan treatment or monitor general health
What is a Class IIb SaMD?
Class IIb
Software providing information for decisions that could result in serious health consequences.
Monitoring software in critical care, dosing calculators for chemotherapy
What is a Class III SaMD?
Class III Software that drives or influences use of a Class III device, or is used for decisions with life-threatening consequences.
AI used to guide cardiac surgery
