UK MPs demand more stringent regulation of medical devices across Europedoi:10.1136/bmj.e7350IngridTorjesenBMJ (Clinical research ed.)
Last month the Medicines and Healthcare products Regulatory Agency (the “MHRA”) launched apublic consultationon the future of medical device regulation in the UK (the “Consultation”). This consultation comes approximately a month after theReport on Medical Devices(the “R...
the UK’s Medicines and Medical Devices Act of 2021 was passed to address the regulatory gap for medical devices created when the UK officially left the European Union (EU) in January 2021. Until then, medical devices were required to meet EU regulatory requirements, including the EU’s Medica...
摘要: A letter to the editor is presented in response to the article "The regulation of medical devices: unsatisfactory, unscientific, and in need of major overhaul," by P. Wilmshurst in the May 13, 2011 issue.被引量: 1 年份: 2011 ...
Transition to the EU MDR medical device regulation (EU) 2017/745 with a full scope notified body and the expertise and experience of our technical specialists.
J. S. (2009) European Regulation of Medical Devices, in The Textbook of Pharmaceutical Medicine, 6th Edition (ed J. P. Griffin), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444317800.ch20 Editor Information 2 Asklepieion Consultancy Ltd., Herts, UK 3 British Pharmaceutical Industry, London...
international standards and global congruity in devising new systems of regulation. It is also in conversation with stakeholders in the healthcare and life sciences industry on the proposed bill to deliver a robust regulatory framework for scrutinising the medical devices...
Medical device regulations were criticised last week by manufacturers who make devices and doctors who use them. At a press briefing on 16 February, manufacturers said the regulations were unnecessarily cumbersome, while doctors criticised them for being inadequate and subject to conflicts of interest....
Further guidance can be found on GOV.UK website and our dedicated UKCA web page.Yours sincerely, Vishal Thakker Head of UK Approved BodyRegulatory Services (Medical Devices), BSISHARE Normen ISO 9001 Kwaliteitsmanagement ISO 13485 Medische hulpmiddelen ISO 14001 Milieumanagement ISO 19650 Building ...
But guess what – that’s all part of the government’s plan. Under its national AI strategy, the UK has expressed ambitions to become a “global AI superpower” within the next decade. And they have a good shot at it – the UK currently has the third highest number of AI companies ...