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Regulating medical devices in the UK - GOV.UK
- https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
Register medical devices to place on the market - GOV.UK
- https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market
- How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern …
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 vigilance …
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 …
Medical device safety information produced by the MHRA
- https://www.gov.uk/drug-device-alerts/medical-device-safety-information-produced-by-the-mhra
- Medicines and Healthcare products Regulatory Agency Published 12 February 2021 Message type: Device safety information Issued: 12 February 2021 …
New UK MHRA Medical Devices Regulations Published - NAMSA
- https://namsa.com/uk-mhra-medical-device-regulations-published/
- On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority (MHRA) published the results and conclusions from the …
Public Access Database for Medical Device Registration
- https://aic.mhra.gov.uk/era/pdr.nsf/Search?openform
- Registration does not represent any form of accreditation, certification or approval by the UK Competent Authority(MHRA) Where a conformity assessment certificate is listed as …
UK MHRA Updates Roadmap for New Medical Device Regulations
- https://www.emergobyul.com/news/uk-mhra-updates-roadmap-new-medical-device-regulations
- The MHRA presented a webinar on the UK Medical Devices Regulations on January 24, 2023. The webinar featured the staff of the MHRA updating on the …
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 a …
UK MHRA Medical Device Regulations: and IVD Products | NAMSA
- https://namsa.com/uk-mhra-medical-device-regulations-impact-to-ivd-manufacturers/
- As previously discussed in NAMSA’s blog post, “ New UK MHRA Medical Device Regulations Published ,” on 28 June, the UK’s Medical Devices and Healthcare …
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