This page provides links to the latest information about the regulation of medicines ('Devices regulatory news').
Latest news and hot topics
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03 May 2012 | Medical Devices Anti-Counterfeiting Forum – 31 May 2012
The Medicines and Healthcare products Regulatory Agency has identified a growing threat from counterfeit medical devices over the last 12 months, which has resulted in the creation of a permanent forum to highlight current trends and threats to UK patients.
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29 Mar 2012 | Work-Related Deaths Protocol (WRDP) for England and Wales
The Medical Devices Division of the MHRA has signed up to the Work-Related Deaths Protocol for England and Wales (WRDP), a working arrangement with the Health and Safety Executive, with effect from 1 April 2012.
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29 Mar 2012 | Regulation on electronic instructions for use of medical devices published
Regulation 207/2012 which sets out details on how and when manufacturers may use electronic, rather than paper, instructions for use was published in the Official Journal of the European Union earlier this month.
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15 Mar 2012 | Letters to be sent out to customers with unpaid and overdue invoices
From Monday 19 March, MHRA Finance will be sending out letters to customers with unpaid and overdue invoices. After this date, you will receive two letters in quick succession. These initial letters will detail all invoices that MHRA consider outstanding and payable. You will then receive periodic reminders following the generation of invoices.
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12 Mar 2012 | Informal consultation - update to Medical Device Regulations
The MHRA is seeking views on the approach to implementing EU Directive 2011/100/EU.
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12 Mar 2012 | Amendment of Directive 98/79/Ec on In-Vitro Diagnostic Medical Devices - consultation letter
(180Kb)
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07 Mar 2012 | MHRA consultation on Guidance for Notified Bodies on the regulation of IVDs for self-testing
The MHRA is consulting on a draft guidance document intended to support the Notified Body assessment of in vitro diagnostic medical devices for self testing (self tests or home tests). Comments should be received by 5 May 2012.
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03 Feb 2012 | Medical Device Technology Forum on hip implants
An orthopaedic workshop, held on 4 November 2011, explored the difficulties in promoting innovation in the orthopaedic field while maintaining patient safety.
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30 Jan 2012 | Poly Implant Prothese (PIP) breast implants update
Women concerned about PIP breast implants can find all the latest NHS information on NHS Choices.
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24 Jan 2012 | Department of Health sets out scope of PIP implant and cosmetic surgery reviews
The Department of Health has today published the terms of reference for two reviews established following the recent concerns about PIP implants.
