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How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
Guidance for organisations when making decisions about the design and operation of enterprise IT services which handle OFFICIAL information.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
How to write clear and effective field safety notices (FSNs) for medical devices.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
A list of places to find Defence contracts and funding in the technology and innovative research and development (R&D) space.
Guidance on choosing evaluation study types and methods.
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