Medical Device Competent Authority Uk

Approved bodies for medical devices - GOV.UK

https://www.gov.uk/government/publications/approved-bodies-for-medical-devices/approved-bodies-for-medical-devices

From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory...

Regulating medical devices in the UK - GOV.UK

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

Medicines and Healthcare products Regulatory Agency

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

18 January 2023 — Press release The Medicines and Healthcare products Regulatory Agency (MHRA) has confirmed that UL International UK Ltd is now designated to assess …

Register medical devices to place on the market - GOV.UK

https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market

Global Medical Devices Nomenclature ( GMDN) code and term to describe your device Basic UDI-DI (if applicable) medical device name (brand/trade/proprietary …

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

Updated 26 February 2019 Medical devices: the regulations and how we enforce them MHRA is the designated authority that administers and enforces the law on medical …

List of Competent Authorities for Medical Devices - AKRN

https://akrnconsulting.com/list-member-states-competent-authorities-for-medical-devices/

The competent authority belongs to the government of the Member State of the European Union (EU) and their responsibility is to transposes the requirements of …

Medical Device Directives - abhi.org.uk

https://www.abhi.org.uk/what-we-do/regulation/medical-device-legislation/medical-device-directives/

In the UK the competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA). The Medical Devices Directive (93/42/EEC) classifies products …

CAMD - Competent Authorities for Medical Devices : CAMD

https://www.camd-europe.eu/

The European Competent Authorities for Medical Devices (CAMD) met for its 51st meeting in Prague on the 20th – 21st October 2022 under the Czech Presidency of the Council of …

Home | UK Responsible Person

https://ukrepmed.com/

From the 1st January 2022 all Manufacturers based outside the UK need to appoint a UK Responsible Person who then registers the devices with the UK competent health …

National competent authorities (human) | European …

https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human

The national competent authorities are primarily responsible for the authorisation of medicines available in the EU that do not pass through the centralised procedure. They …