E-Label – Eisner Safety Consultants

UK MHRA Guidance on EU Regulation 207/2012 on electronic labeling of med dvcs

leoeisner — Mon, 06 May 2013 04:41:22 +0000

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:

1 Step Closer to EU Medical Device e-Labeling

leoeisner — Tue, 17 Jan 2012 19:38:05 +0000

Per Eucomed’s 7 October 2011 newsletter electronic labeling of medical devices (MDD & AIMDD) has been approved as a draft regulation and is in the hands of “the Council and European Parliament who will have 3 months to exercise their right of scrutiny and evaluate whether the European Commission has exceeded its powers with this proposed regulation.

Final publication and entry into force is expected at the beginning of 2012.”

Med Dvcs E-Lableing: Health Canada TPD’s Interpretation

leoeisner — Tue, 04 Jan 2011 00:54:15 +0000

On November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with respect to electronic labeling (e-labeling) of certain medical devices sold or imported into Canada. This interpretation only covers products for professional use and not products sold to the general public.

Per the Interpretation issued e-labelling refers to the information required by section 21(1) of the Regulations (Medical Devices Regulations – SOR/98-282) that would ordinarily be found in the directions for use. Per the notice:

“The directions for use may include a surgeon’s instruction manual, operator’s manual, or user’s manual. At this time, the only acceptable electronic media in which to present information to satisfy the labeling requirements of section 21(2) of the Regulations are those described below.

Electronic labelling may be provided on Compact Disc (CD) or Digital Video Disc (DVD), accompanying the device at the time of sale and/or delivery….The CD/DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on CD/DVD should be easily navigable.

For the following two categories of devices…, this information may, in the alternative, be provided in downloadable format from the internet: Class IV medical devices and in vitro diagnostic devices (IVDDs) that do not fall within the definition of near patient IVDD. The internet address must accompany these devices at the time of sale and/or delivery, and be displayed in a manner that alerts the user to its purpose…

Manufacturers should ensure that the labelling information provided in electronic format is identical in content to the paper format submitted with the device licence application…

Upon request, a paper copy of the label information should be provided promptly to the user, without additional cost.

Since this Notice is permissive in nature, it is effective immediately….”

For full text of the notice click here or go to the Health Canada webpage for this notice.