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The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
The call for applications for phase 2 of the AI Airlock is now closed.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Information on how to request assistance from the NSDR.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
Information about how approved bodies help regulate medical devices and how to apply for approval.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
How we engage and involve patients and the public in our regulatory decision-making.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing, access and growth in 2025.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
MHRA’s mechanism for evaluating the justifications supplied by applicant organisations who plan to utilise decentralised manufacture.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
This guide has been provided to reduce the burden when preparing responses to Post Inspection Letters.
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