Medical Device Regulation Flashcards
who are the two UK regulators?
Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Healthcare and excellence (NICE)
List some medical devices
- spectacles
- contact lenses
- dental fillings
- apple watch (apple is FDA approved)
What is a medical device?
The (TGA) Australia defines a medical device as an instrument, apparatus, appliance, material or other article intended to be used in human beings for:
- Diagnosis, prevention, treatment or alleviation od disease, injury or disability
- investigation, replacement or mediation of the anatomy of a physiological process.
- control of conception
How are medical devices classified?
Product Risk Class (HIGH-LOW), Level of Regulatory Control (HIGH_LOW).
Describe class I
Lowest risk: gloves, wheelchair, spectacles
Describe class IIa
Contact Lenses, Catheters
Describe class IIb
Condoms, blood bags
Describe class III
Highest risk: heart valves
Describe implants
Subset of medical devices: goes inside the human body, replacement joints, heart valves, stents, breast implants
What if something goes wrong with implants?
2012: House of Commons select committee produced report (Regulations of Medical Implants in EU and UK)
government has to respond
What is the EU MDR 2017/45?
recent EU legislation on medical devices (and therefore implants). Comes into effect in 2020, gives companies 3 years to swap between legislation’s. Replaces Medical Devices Directive (1993)
Will the new legislation make a difference?
Potentially better but:
- lack of transparency
- notified bodies are still commercialised interests (profit)
- no clinical investigation’s required if implant is substantially equivalent
- post brexit?
What is post market surveillance?
A statutory requirement of manufacturers
- Needs to be a post market surveillance plan to include:
- information of serious incidents
- relevant literature or registries
- complaints
- information about similar medical devices
should be procedural and systematic
What tools are used in post market surveillance?
Risk management plans
Adverse event reporting
Environmental scanning (seeking confidential advice from other regulators and review of medical literature)
What is an adverse event?
For both medicines and medical devices: an event they resulted in, or could have resulted in, serious injury, illness or death
