A number of directives on medical device vigilance have been updated, the new rules are not binding but are presented as best practice.
Directives 90/385/EEC implantable medical devices, 93/42/EEC medical devices and 98/79/EEC and in-vitro diagnostics, all require a manufacture to implement a devices vigilance system to ensure reporting and evaluation of incidents.
Medical Devices without a CE-mark
These guidelines apply to all devices with or without a CE mark, more importantly the obligation does not end with the termination of manufacture of medical devices.
Incident criteria – “serious deterioration in state of health” “use of error” and “trends reports”
The revised guidelines list three criteria that turn an event into a notifiable event:
- occurrence of an event
- if the device is suspected to be a contributory cause
- the event led or might led to death or serious deterioration in the state of health of a patient or user
What comprises “serious deterioration in state of health”
- a life-threatening illness
- a permanent impairment of a body function or permanent damage to a body structure
- a condition necessitating medical or surgical intervention to prevent the above
- an indirect harm as a consequence of an incorrect diagnosis or
- foetal distress, foetal death or any congenital abnormality or birth defects.
There is also an obligation to report “use errors” which result in death or serious deterioration in state of health or are a serious public health threat.
Trend reports need to be submitted where there is a significant increase in the rate of: reportable incidents, incidents that are usually exempt from reporting; and events that are usually not reportable.
Timescales
The timescales are as followes:
- Serious public heath threats should be reported immediately (no longer than 2 days)
- Incidents related to death or unanticipated serious deterioration in state of health, must be reported immediately (no longer than 10 days)
- Other incidents immediately after the link is established (no later than 30 days)
Although not legally binding the guidelines are likely to be followed by the industry and regulators.
Reference – Lovells life sciences newsletter summer 2008
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com
