Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): a comparative analysis thelancet.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thelancet.com Daily Mail and Mail on Sunday newspapers.
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In the spirit of MedTech Europe s repeated and vocal calls
to delay the implementation of the IVDR (see previous article here), Team-NB, the trade
association representing 26 leading Notified Bodies, has issued a
direct message to the medical device industry.
The message is clear - as things currently stand, Notified
Bodies will not be able to cope with the titanic workload as a
series of waves hit:
the MDR comes into force in May
2021;
the IVDR comes into force in May
2022; and
the transition period expires in May
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.