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The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) launched a four-week consultation which will support improved safety for certain high risk in vitro diagnostic (IVD) devices.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products.
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagnostic tool for imaging of the heart, to evaluate blood flow and aid in the diagnosis or assessment of...
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
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