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Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
How to decide what your charity’s purposes are and write them in the ‘objects’ clause of your governing document.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
The Industrial Energy Transformation Fund (IETF) supports the development and deployment of technologies that enable businesses with high energy use to transition to a low carbon future.
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