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Regulating medical devices in the UK - GOV.UK
- https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. This guidance provides information on the UK system, including for: 1. getting your device certified 2. conformity marking your device 3. registering your device with the MHRA This … See more
Medical devices: the regulations and how we enforce them
- https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices
- Medical devices: the regulations and how we enforce them Medical devices: the regulations and how we enforce them. MHRA is the designated authority that …
Factsheet: medical devices overview
- https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
- Regulations on medical devices Medical devices in the UK are regulated by the Medical Devices Regulations 2002 (as amended) which provides for a system of …
Regulatory guidance for medical devices - GOV.UK
- https://www.gov.uk/government/collections/regulatory-guidance-for-medical-devices
- Regulatory guidance for medical devices Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA …
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 …
Medicines and Healthcare products Regulatory Agency
- https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about
- ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness) secure safe supply chain for …
Managing Medical Devices - GOV.UK
- https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/982127/Managing_medical_devices.pdf
- management of their medical devices, including strategic replacement and development equipment procurement planning. This should include an overarching medical devices …
Medical devices: guidance for manufacturers on vigilance
- https://www.gov.uk/government/collections/medical-devices-guidance-for-manufacturers-on-vigilance
- The MHRA is responsible for the UK medical device market. Once a medical device has been placed on the UK market, the manufacturer must submit …
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 …
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,” …
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