The rules governing advertising and promotion of medical devices in the UK — which claims are permitted, the prohibition on advertising unregistered devices, the role of MHRA and the ASA, and the special rules for IVDs and implantable devices.
MHRA annual registration and compliance fees for medical device manufacturers and UKRPs — fee structure, payment, and what happens if fees are not paid.
The distribution record-keeping requirements for medical device manufacturers and importers under the UK MDR 2002 — what must be recorded, retention periods, and why adequate records are essential for effective recalls and FSCAs.
Circumstances in which a serious incident is exempt from mandatory individual reporting to MHRA under UK MDR 2002, and how to document non-reporting decisions.
What a Field Safety Notice must contain, how it should be distributed, MHRA review of FSN content, and the mandatory elements under the UK MDR 2002 and MHRA guidance.
Practical mechanics of submitting vigilance reports to MHRA — the Submissions portal for manufacturers and UKRPs, the Yellow Card scheme for healthcare professionals and patients, report content requirements, and post-submission follow-up.
How manufacturers and UKRPs must maintain their MHRA registration throughout the device lifecycle — when to update registrations, what changes trigger an update obligation, and the consequences of outdated registration.
The labelling requirements for medical devices placed on the GB market under UK MDR 2002 Schedule 1, Essential Requirement 18 — mandatory label elements, UKCA mark placement, UKRP details, language requirements, and IFU obligations.
A stage-by-stage overview of the regulatory lifecycle of a medical device in Great Britain — from concept and classification through pre-market conformity assessment and MHRA registration to post-market surveillance, vigilance, and end-of-life obligations under the UK MDR 2002.
The powers MHRA can exercise to initiate safety actions independently of manufacturers — including suspension and prohibition notices, recall orders, public warnings, and enforcement under the UK MDR 2002.
Which changes to a device, its manufacturer, or its UKRP must be formally notified to MHRA — and which changes are handled through registration update vs. separate notification.
PSUR requirements for Class IIa, IIb, III, AIMD, and higher-risk IVDs under the UK MDR 2002 — what a PSUR must contain, frequency, relationship to PMS data, and UKAB access requirements.
What claims are permitted and prohibited in UK medical device labelling, IFU, and advertising — including performance claims, clinical outcome claims, comparison claims, and the prohibition on claims that exceed the device's registered intended purpose.
Post-market surveillance obligations for each device class under the UK MDR 2002 — what PMS must cover, the PMS plan and report, class-specific requirements, and PSUR frequency.
PMCF requirements for medical devices under the UK MDR 2002 — what PMCF is, when it is required, PMCF plan and report structure, methods, and how PMCF data feeds back into the clinical evaluation.
An overview of the post-market obligations for medical device manufacturers and economic operators under the UK Medical Devices Regulations 2002 — what continues after a device is placed on the GB market and why post-market compliance is as important as pre-market compliance.
How a medical device recall is conducted in the UK — the types of recall action, working with MHRA, recall classifications, logistics, completion evidence, and post-recall follow-up.
Mandatory timeframes for reporting serious incidents and FSCAs to MHRA — 2-day, 10-day, and 30-day reports, initial vs final reports, and how to handle ongoing investigations.
When and how to submit a trend report to MHRA — criteria for a reportable trend, statistical significance, report content, and the relationship to PMS and PSURs.
The events that trigger mandatory vigilance reporting under the UK MDR 2002 — serious incidents, FSCAs, trend reports, and the criteria for determining whether an event is reportable.
The criteria that require a manufacturer to initiate a Field Safety Corrective Action (FSCA) under the UK MDR 2002 — what constitutes an FSCA, how to decide if action is needed, and the relationship between FSCAs and vigilance reporting.