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 Ireland
From: Contents
MHRA under existing arrangements:
MHRA subject to grace periods, depending on the class of devices.
In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK
MDR 2002) as they apply in Great Britain so that they can be registered with the
MHRA.
The
MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).
Regulating medical devices in the UK
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
From:
MHRA) is responsible for regulating the UK medical devices market.
This guidance provides information on the UK system, including for:
getting your device certified
MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.
Apply for a licence to market a medicine in the UK
How to license a medicine for sale in the UK, including applications through national and international routes.
From: Contents
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This guidance also covers licensing a medicine in Northern Ireland through the centralised, decentralised and mutual recognition European procedures.
Which procedure to follow
There are several routes to obtain a marketing authorisation in the United Kingdom (UK), Great Britain (England, Scotland and Wales) or Northern Ireland. The options available will be determined by the intended market and the type of application. The markets in which each route is applicable are indicated in the following guidance:
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