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Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information and guidance on a range of medical devices for users and patients.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
How to conform with the legal requirements for placing medical devices on the market.
Information about the EU Regulations and their implementation in Northern Ireland
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The workshop was held in Pune on Friday, 13 February 2015.
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