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Guidance on what approved bodies are, what they do and how you can become one.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
How to conform with the legal requirements for placing medical devices on the market.
The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies, delivering increased capacity for the certification of the performance and safety of medical devices, for healthcare professionals and the public.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information about the EU Regulations and their implementation in Northern Ireland
Find out which COVID-19 test products have been approved.
Advice for manufacturers of Class I medical devices for placing products on the UK market
How to get an ENG1 or ML5 medical certificate.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Find out about MCA's recruitment process for approved doctors (ADs).
A list of overseas-based approved doctors for UK seafarers.
A list of healthcare providers, and the doctors approved to carry out ENG 1 medical examinations.
Application form to become a Maritime and Coastguard Agency (MCA) approved doctor.
Guidance for NHS regarding disclosure to individuals holding either a Lasting Power of Attorney or a deputyship.
Don’t include personal or financial information like your National Insurance number or credit card details.
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