

<rss version="2.0" xmlns:atom="http://www.w3.org/2005/Atom">
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	<title>Devices regulatory news feed</title>
	<link>http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&amp;nodeId=100806</link>
 

<item>
<title>MHRA evidence to the Science and Technology Select Committee inquiry on medical implants</title>
<pubDate>Mon, 21 May 2012 15:40:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON152720 </link>
	 <description><![CDATA[The House of Commons Science and Technology Select Committee recently announced an inquiry into the regulation of medical implants.<br/> ]]></description>
	 </item>
 

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<title>Medical Devices Anti-Counterfeiting Forum – 31 May 2012</title>
<pubDate>Thu, 03 May 2012 11:23:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON152584 </link>
	 <description><![CDATA[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.<br/> ]]></description>
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<title>Work-Related Deaths Protocol (WRDP) for England and Wales</title>
<pubDate>Fri, 30 Mar 2012 14:06:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON146895 </link>
	 <description><![CDATA[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.<br/> ]]></description>
	 </item>
 

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<title>Regulation on electronic instructions for use of medical devices published</title>
<pubDate>Thu, 29 Mar 2012 14:17:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON146885 </link>
	 <description><![CDATA[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.<br/> ]]></description>
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<item>
<title>Letters to be sent out to customers with unpaid and overdue invoices</title>
<pubDate>Thu, 15 Mar 2012 10:46:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON146698 </link>
	 <description><![CDATA[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.<br/> ]]></description>
	 </item>
 

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<title>Informal consultation - update to Medical Device Regulations</title>
<pubDate>Mon, 12 Mar 2012 16:29:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON146619 </link>
	 <description><![CDATA[The MHRA is seeking views on the approach to implementing EU Directive 2011/100/EU.<br/> ]]></description>
	 </item>
 

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<title>Amendment of Directive 98/79/Ec on In-Vitro Diagnostic Medical Devices - consultation letter</title>
<pubDate>Mon, 12 Mar 2012 16:03:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/home/groups/comms-ic/documents/regulatorynews/con146622.pdf</link>
	 <description><![CDATA[The MHRA is seeking views on the approach to implementing EU Directive 2011/100/EU.<br/> ]]></description>
	 </item>
 

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<title>MHRA consultation on Guidance for Notified Bodies on the regulation of IVDs for self-testing</title>
<pubDate>Wed, 07 Mar 2012 11:36:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON146533 </link>
	 <description><![CDATA[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.<br/> ]]></description>
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<title>Medical Device Technology Forum on hip implants</title>
<pubDate>Wed, 08 Feb 2012 16:15:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON143549 </link>
	 <description><![CDATA[An orthopaedic workshop, held on 4 November 2011, explored the difficulties in promoting innovation in the orthopaedic field while maintaining patient safety.<br/> ]]></description>
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<title>Information regarding In Vitro Diagnostic Directive (IVDD) notifications for IVD device registrations</title>
<pubDate>Mon, 07 Nov 2011 16:00:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON134822 </link>
	 <description><![CDATA[Information regarding In Vitro Diagnostic Directive (IVDD) 98/79EC notifications for IVD device registrations under Article 10 submitted with other EU Member States.<br/> ]]></description>
	 </item>
 

<item>
<title>&#39;Red Tape Challenge&#39;: Your views on regulatory enforcement</title>
<pubDate>Thu, 11 Aug 2011 10:02:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON126049 </link>
	 <description><![CDATA[The 'Red Tape Challenge' is a government initiative to reduce the burden of regulation. It enables you to comment on government regulations.<br/> ]]></description>
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<title>The MHRA announces the closure of the Assistive Technology Centre at Blackpool</title>
<pubDate>Tue, 09 Aug 2011 09:16:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON126021 </link>
	 <description><![CDATA[The MHRA has announced that the Assistive Technology Centre at Blackpool will be closing and the work of the unit will be transferred to its London offices.<br/> ]]></description>
	 </item>
 

<item>
<title>Council conclusions on innovation in the medical device sector published</title>
<pubDate>Thu, 09 Jun 2011 09:44:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON120293 </link>
	 <description><![CDATA[The council conclusoins on innovation in the medical device sector, adopted 6 June 2011, are now availble to view.<br/> ]]></description>
	 </item>
 

<item>
<title>Change to the clinical trials for medical devices notifications process</title>
<pubDate>Wed, 06 Apr 2011 15:51:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON114418 </link>
	 <description><![CDATA[When submitting a notification about a clinical trial for a medical device, applicants should be aware that they now need to provide a copy of the Payment Transaction Receipt when paying by bank transfer.<br/> ]]></description>
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<title>Outcome of the European Commission public consultation on the revision of the In Vitro Diagnostic Medical Devices Directive (98/79/EC)</title>
<pubDate>Thu, 24 Feb 2011 17:34:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON108894 </link>
	 <description><![CDATA[The Commission has now published a summary report of the public consultation on technical aspects of the revision of the In Vitro Diagnostic Medical Dvice Directive results on it's website.<br/> ]]></description>
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<title>New Interpretive Document of the Commission&#39;s Services - Placing on the Market of Medical Devices</title>
<pubDate>Tue, 07 Dec 2010 10:11:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON102818 </link>
	 <description><![CDATA[The European Commission has published its interpretive document regarding the interpretation of 'placing on the market' in the context of the medical devices directives.<br/> ]]></description>
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<title>Suspected fraud involving impersonation of British authorities</title>
<pubDate>Thu, 11 Nov 2010 15:49:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON099898 </link>
	 <description><![CDATA[It has been brought to the Agency's attention that a number of manufacturers and their stakeholders groups have been approached via email from the British Health Agency that there is additional fees payable to manufacturers and importers of medical devices and medicines and supplying a extract from the UK Health Gazette.<br/> ]]></description>
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<title>Home use blood glucose tests: Final report of the joint European, co-ordinated market surveillance project</title>
<pubDate>Wed, 03 Nov 2010 22:48:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON099748 </link>
	 <description><![CDATA[The final report from a joint European exercise, to provide clear and harmonised instructions for self-test blood glucose meters and test strips, is now available.<br/> ]]></description>
	 </item>
 

<item>
<title>Home-use blood glucose tests: Final report of the joint European, co-ordinated market surveillance project</title>
<pubDate>Wed, 03 Nov 2010 16:32:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/home/groups/dts-bs/documents/regulatorynews/con099749.pdf</link>
	 <description><![CDATA[<br/> ]]></description>
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<item>
<title>Phthalates/DEHP in PVC medical devices</title>
<pubDate>Fri, 29 Oct 2010 19:00:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON062986 </link>
	 <description><![CDATA[Any questions on regulatory aspects should be directed to these contacts.<br/> ]]></description>
	 </item>
 

<item>
<title>EU Competent Authority Meeting for Medical Devices in Liège</title>
<pubDate>Tue, 12 Oct 2010 13:50:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON096863 </link>
	 <description><![CDATA[The EU Competent Authority Meeting for Medical Devices in Liège took place on the 23-24 September 2010 and a press release has been issued.<br/> ]]></description>
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<title>Access to the Medical Devices Register now available via the MHRA website</title>
<pubDate>Thu, 30 Sep 2010 13:51:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON094206 </link>
	 <description><![CDATA[Following the  implementation of Directive 2007/47/EC, information on the registration of persons responsible for placing devices on the market in accordance with Article 14 is now available via our website.<br/> ]]></description>
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<item>
<title>Relocation of the MHRA head office</title>
<pubDate>Fri, 13 Aug 2010 14:32:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON091029 </link>
	 <description><![CDATA[The MHRA head office in Vauxhall, London, will be moving to a new London location in October 2010.  We will ensure there will be minimal disruption to services for all our stakeholders during the move. This new section of the website will be updated as further details about the move become available and will include updated contacts details and specific information for those who work with the Agency.<br/> ]]></description>
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<item>
<title>Reporting a non-compliant medical device</title>
<pubDate>Thu, 05 Aug 2010 10:14:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON090864 </link>
	 <description><![CDATA[A new section has been added to the MHRA website focusing on reporting non-compliant medical devices.<br/> ]]></description>
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<item>
<title>Revision of the In Vitro Diagnostic Medical Devices Directive</title>
<pubDate>Mon, 05 Jul 2010 15:45:00 UTC</pubDate>
<link>http://www.mhra.gov.uk/Howweregulate/Devices/Devicesregulatorynews/CON087763 </link>
	 <description><![CDATA[The European Commission has launched a public consultation on the technical aspects of the revision of Directive 98/79/EC on in vitro diagnostic (IVD) medical devices.<br/> ]]></description>
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