Intended for healthcare professionals


EU agrees tighter standards for medical devices

BMJ 2016; 353 doi: (Published 01 June 2016) Cite this as: BMJ 2016;353:i3058
  1. Rory Watson
  1. Brussels

The European Union has agreed major changes to its 20 year old regulatory framework for medical devices. These will introduce stricter rules and higher standards on the manufacture, authorisation, and sale of medical devices, ranging from sticking plasters and pacemakers to artificial hips and breast implants.

The European Commission tabled the draft legislation in 2012 after the discovery the previous year of defective silicone gel breast implants manufactured by the French company Poly Implant Prothèse (PIP). Political agreement on the amended legislation, along with new rules on in vitro diagnostic products, was finally reached late on 24 May after lengthy negotiations …

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