Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
How to write clear and effective field safety notices (FSNs) for medical devices.
Guidance for manufacturers of coronary stents. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
