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.
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.
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.