Guidance: Medical devices: periodic safety update report
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
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.
Summary of the latest safety advice for medicines and medical device users
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
Maxearn Limited have informed the MHRA that the carton used to package two imported batches of Inhixa have been released to the market with a typographical error on one side of the carton.
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Patients to benefit from new era in cancer treatment, as Government slashes red tape to unleash life-saving innovation
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Guidance on labelling requirements pertinent to the type of medicinal product and its supply status, as defined in UK legislation.