Mhra Medical Devices Research

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Regulating medical devices in the UK - GOV.UK

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

Notify the MHRA about a clinical investigation for a …

https://www.gov.uk/guidance/notify-mhra-about-a-clinical-investigation-for-a-medical-device

The MHRA is working with the Health Research Authority ( HRA) to develop a new coordinated assessment pathway which will streamline the review of clinical …

Factsheet: medical devices overview

https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview

A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by human beings for a medical...

Regulatory guidance for medical devices - GOV.UK

https://www.gov.uk/government/collections/regulatory-guidance-for-medical-devices

Medical devices regulations: compliance and enforcement 26 February 2019 Guidance Virtual manufacturing of medical devices 3 February 2021 Guidance Notify the …

Medicines and Healthcare products Regulatory Agency

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

The Medicines and Healthcare products Regulatory Agency (MHRA) has received a total of £970,688 from BEIS’ Regulators’ Pioneer Fund for three projects that aim to unlock …

New UK MHRA Medical Devices Regulations Published - NAMSA

https://namsa.com/uk-mhra-medical-device-regulations-published/

New UK MHRA Medical Devices Regulations Published | NAMSA. On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority …

Medical device safety information produced by the MHRA

https://www.gov.uk/drug-device-alerts/medical-device-safety-information-produced-by-the-mhra

The MHRA is accredited to publish National Patient Safety Alerts (NatPSA) for medical devices and medicines. These alerts are sent to the NHS in England. The …

Medical devices and software applications - Health …

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/medical-devices-and-software-applications/

The HRA is working with the Medicines Healthcare products Regulatory Agency (MHRA) to develop a new coordinated assessment, which will streamline the …

UK MHRA Updates Roadmap for New Medical Device Regulations

https://www.emergobyul.com/news/uk-mhra-updates-roadmap-new-medical-device-regulations

The MHRA highlighted patient safety and benefit, “need for patient safety and being supportive in an operating environment to support industry and patients,” …

Decide if your product is a medicine or a medical device

https://www.gov.uk/guidance/decide-if-your-product-is-a-medicine-or-a-medical-device

The MHRA determines whether a product falls within the definition of a medicine – ‘medicinal product’ or a medical device and provides information on whether …

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