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Changing Medical Device Regulations in the United Kingdom & Europe

Changing Medical Device Regulations in the United Kingdom & Europe
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Register medical devices to place on the market

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). ....

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Regulating medical devices in the UK

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. ....

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Register medical devices to place on the market from 1 January 2021

Register medical devices to place on the market from 1 January 2021
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United Kingdom , Northern Ireland , Great Britain , Medical Devices Regulations , United Kingdom Responsible Persons , Authorised Representatives , Medical Device , United Kingdom Responsible Person , Authorised Representative , United Kingdom Responsible , Northern Ireland Based Authorised Representative , Kingdom Approved Body , Device Online Registration System , United Kingdom Authorised Representative , Device Registration , Free Sale System , Public Access Database , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , நன்று பிரிட்டன் , மருத்துவ சாதனங்கள் ஒழுங்குமுறைகள் , ஒன்றுபட்டது கிஂக்டம் பொறுப்பு நபர்கள் , அங்கீகாரம் பெற்றது பிரதிநிதிகள் , மருத்துவ சாதனம் , ஒன்றுபட்டது கிஂக்டம் பொறுப்பு நபர் , அங்கீகாரம் பெற்றது பிரதிநிதி ,