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Medical devices: new EU regulations won’t guarantee safe design, doctors warn

BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l4446 (Published 27 June 2019) Cite this as: BMJ 2019;365:l4446
  1. Jane Feinmann
  1. London, UK

Doctors have been urged to inform their trusts when medical devices are difficult to use or have confusing instructions, amid concerns that new European regulations will fail to guarantee safe design of the devices that doctors are asked to use.

Tom Clutton-Brock, clinical director of the Medical Devices Testing and Evaluation Centre, told a Clinical Human Factors Group (CHFG) meeting in London on 12 June that new EU medical devices regulation that will come in force in May 2020 forms “an excellent basis for much safer design but it remains to be seen how these new rules are interpreted and enforced.”

Under the new regulation, manufacturers will be required to provide in-depth clinical data underpinning safety and performance claims, along with …

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