MHRA – Eisner Safety Consultants https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Mon, 06 May 2013 04:41:22 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png MHRA – Eisner Safety Consultants https://eisnersafety.com 32 32 UK MHRA Guidance on EU Regulation 207/2012 on electronic labeling of med dvcs https://eisnersafety.com/2013/05/06/uk-mhra-guidance-on-eu-regulation-2072012-on-electronic-labeling-of-med-dvcs/?utm_source=rss&utm_medium=rss&utm_campaign=uk-mhra-guidance-on-eu-regulation-2072012-on-electronic-labeling-of-med-dvcs Mon, 06 May 2013 04:41:22 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=3367 On 9 Jan 2013 the UK MHRA (The Medicines and Healthcare products Regulatory Agency) released a Guidance on EU Commission Regulation 207/2012 on electronic labeling of medical devices.  This regualtion came into force on 1 March 2013 so you can rely on this guidance to help you meet the regulation.  The UK MHRA webpage includes the text of their guidance for how to apply the requirements of 207/2012 on electronic labeling of medical devices.

Past posts to refer to includes:

]]> UK MHRA Revamped Website! https://eisnersafety.com/2012/01/18/uk-mhra-revamped-website/?utm_source=rss&utm_medium=rss&utm_campaign=uk-mhra-revamped-website Wed, 18 Jan 2012 05:00:41 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2362 The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site!

The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical devices. Also, you can find the UK transposed regulations and many other useful items such as classification information, borderline documents, the conformity assessment process, regulatory news, details on revisions of the MDD, Vigilance, Notified Bodies, and much much more. The site links you to multiple places to the Europa website for things such as the Interpretation & guidance documents and more…

If you are looking for information on Medical Devices under the MDD this is a good link to look at for lots of information on the subject.

If you are looking for information on Medicines legislation & directives this is a good link to look at for lots of information on the subject.

They even set-up a page for New Technologies Forums for both Medicines and Medical Devices.

]]> MHRA Risk-based inspection for all Sites Inspected > 1 Apr 09 Submit Updates of Sig Chngs https://eisnersafety.com/2010/05/27/mhra-risk-based-inspection-for-all-sites-inspected-1-apr-09-submit-updates-of-sigchngs/?utm_source=rss&utm_medium=rss&utm_campaign=mhra-risk-based-inspection-for-all-sites-inspected-1-apr-09-submit-updates-of-sigchngs Thu, 27 May 2010 18:44:52 +0000 http://www.eisnersafety.com/eisnersafetycom/mhra-risk-based-inspection-rb/ MHRA Risk-based inspection all sites inspected after 1 Apr ’09 under Risk-based inspection to submit updates of significant changes between inspections: form & guidance at http://ht.ly/1QMZk

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