Uk Competent Authority Medical Devices

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

A UK Responsible Person is not required on order to place IVDs that do not fall within these device classifications on the Northern Ireland market. Non-UK …

Medical devices: conformity assessment and the UKCA …

https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ukca-mark

You need to demonstrate that your medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. The assessment route …

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 devices: the regulations and how we enforce …

https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/how-mhra-ensures-the-safety-and-quality-of-medical-devices

The Regulation of Medical Devices in the UK If you are a manufacturer based in the UK and you intend to supply medical devices in the UK then you need to be aware of the …

Medical devices: how to comply with the legal …

https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements

Examples of active implantable medical devices include: implantable cardiac pacemakers implantable defibrillators leads, electrodes, adaptors for the above …

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 …

United Kingdom Medical Device Regulation

https://www.trade.gov/market-intelligence/united-kingdom-medical-device-regulation

UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), has issued guidance relating to the regulation of medical devices and …