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How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Points to consider when using real-world data in clinical studies
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
There is an obligation on the manufacturers and importers of electronic cigarettes to submit a notification of such products they intend to market.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
The VDEC clinical evaluation team works to support vaccine and therapeutic development by providing expertise in immunological and functional assays used to support clinical trials (Phase I to IV)
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
Apply for and maintain registrations for the brokering of human medicines.
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
How the supply of medical devices from Great Britain into Northern Ireland works.
Checklists providing a practical guide to using medical devices.
Report on the service providing sterile, controlled environments for the preparation of injectable medicines into ready-to-administer formats for patients.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Information about suspected side effects of e-cigarettes and how to report side effects.
Personal protective equipment for sale by the Department of Health and Social Care (DHSC) including visors, gowns, aprons and goggles.
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