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Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
Information for manufacturers and users of medical devices containing plastic with DEHP phthalates.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Information about the EU Regulations and their implementation in Northern Ireland
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on sources of electromagnetic interference and mitigating the risks.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to apply for repayment of import duty and VAT on protective equipment or medical supplies brought into the UK from non-EU countries from 30 January 2020 up to 31 December 2020.
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
How the supply of medical devices from Great Britain into Northern Ireland works.
How to get fast-track approval of medical devices during COVID-19.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
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