Drug Regulators, MHRA, Publish Draft Guidance on the Vigilance System for CE-marked devices – Neurostimulators.
A full copy is available here.
Introduction
This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations.
Why Report
To obtain information on device related incidents, the Medical Devices Directive requires manufacturers to have procedures in place for systematic review of experience gained from device usage in the post-production phase.
What Should Be Reported
The Medical Devices Directive, through the relevant national regulations [4], requires manufacturers to notify the relevant competent authority (the MHRA in the UK) if:
- They know of any deterioration or malfunction of a neurostimulator, or any inadequacy in the instructions for use which has led, or might lead, to a serious deterioration in the state of health.
- The neurostimulator has been subject to a Field Safety Corrective Action
Periodic Summary Reporting
Some adverse incidents are appropriate for periodic summary reporting:
- lead fracture
- lead shorts
- lead migration
- high lead impedance
- electromagnetic interference
Adverse event trending
Some adverse incidents are expected and foreseeable, and as a result may be considered not routinely reportable. These must all be clearly identified in the manufacturer’s labelling, clinically well recognised and quantifiably predictable, well documented in the device master record with an appropriate risk assessment, and clinically acceptable in terms of individual patient benefit.
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug 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.
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