Tag Archives: UK

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance).  This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to … Continue Reading

Impact of Brexit on EU Medical Devices Regulation and Structures

The UK recently voted to leave the European Union in an advisory referendum. The impact of Brexit on medical devices regulation in the medium-to-long term will very much depend on the form a post-Brexit UK will take, the relationship that the UK chooses to have with the EU, and indeed the relationship that the EU … Continue Reading

UK Data Protection Regulator Surveys Use of Smart Medical Devices

The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps. The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for medical device procurement policies, information governance and incident response … Continue Reading

UK NICE Considers Restrictions on Hip Replacement Implants

The UK National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending tightening standards for hip replacement devices.  If adopted, the tougher standards could force the National Health Service (NHS) to stop using a significant number of existing devices, with obvious impacts on manufacturers of these products.… Continue Reading
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