Eisner Safety Consultants

Our website has just added the News Feed from AAMI (the Association for the Advancement of Medical Instrumentation) to the left side bar on our site.  This is in addition to other useful News Feeds which include AdvaMed SmartBriefs and our own News Feed powered by MedIntelliBase.  All 3 of these News Feed services, which are located on the right & left side bars of our website, will help you stay current on the Medical Device Industry at one website www.EisnerSafety.com in addition to our valuable Industry News blog that helps you stay up to date on the medical device industry regulatory, quality system, product safety and more news & issues.  You can also see a summary of all the Industry News blog postings at www.Twitter.com/EisnerSafety.  Sign-up to follow our blog posts.  We can help you stay current on the subjects that matter to you the most paving the way for you to get your product to market as soon as possible.

Enjoy the news postings!

This article was written by Leo Eisner and is featured in the Journal for Medical Device Regulations in their May 2012 edition.  It is the top article on our Featured Articles WebPage.  This article is on the National Implementations of IEC 60601-1:2005 for the EU under the MDD & AIMDD, Canada under the purview of Health Canada via the Canadian Medical Device Regulations (CMDR), United States of America under the purview of the Food & Drug Administration (FDA), and Brazil under the purview of the National Health Surveillance Agency (ANVISA).  

Enjoy the article!

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:   Below this article from Christine Ruther are several blog postings thx to Erik Vollegbret of Axon Lawyers but to read them you have to go to the bottom of this posting.

Several European medical device guidance documents (MEDDEVs) have been newly released or updated as noted below.  A brief note of significant points is provided.

-        MEDDEV 2.12/1 Medical devices vigilance system (UPDATED – March 2012):

o   Changes that will likely affect your current procedures are:

§  2 new report forms (Annex 7 – Trend Report Form and Annex 6 – Periodic Summary Report Form), and
§  updates to 2 existing report forms (Annex 3 – Incident Report Form and Annex 4 – FSCA Form).

o   The revised guidance is applicable as of 15JUN12.
o   Overall, the content of the guidance has not changed significantly.  Minor changes appear in Section 4.5 – EUDAMED, Section 4.18 – Trend Reporting, Section 5.1.2 – Summary Reporting, Section 5.1.3.6 – Negligible Likelihood, Section 5.1.4 – Trend Reports, Section 6.3.1 – Circumstances (Coordinating NCA), Section 6.3.5 – Information between NCAs, Annex 1 – Examples, Annex 2 – Extracts from Directives, and Annex – GHTF Documents Used.  The numbering of some Annexes has changed.
o   Available at: http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf.  Also see the Manufacturer Incident Report (MIR), http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1-rev_6_mir_en.pdf; How to Use the MIR, http://ec.europa.eu/health/medical-devices/files/meddev/mir_use_en.pdf; and Field Safety Corrective Action report form, Field Safety Corrective Action.

Continue reading EU medical device (MEDDEVs) guidance doc’s newly rls’ed or updated

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther:

The Commission Regulation of electronic instructions for use (IFUs) of Medical Devices 207/2012 was released 10 March 2012.  Here’s a general summary:

• The directive does not cover IVDD devices which have their own guidance document.
• In general, an e-IFU is allowed for:

• AIMDD and MDD devices intended exclusively for professional use where use by other persons is not reasonably foreseeable.
• MDD device fitted with a built-in system visually displaying the instructions for use.

• A documented risk analysis is required covering at least the items listed in Article 4 of the e-IFU directive (intended users’ access to hardware and software to view the e-IFU, intended use environment and access to e-IFU at time of use, etc.).  BSI provided a link, e-IFU REGULATION RISK ASSESSMENT SURVEY, to a general survey which may help avoid the need to run individual surveys.  As with all risk analyses, it must be updated based on experience from the post-marketing phase. Continue reading Electronic IFUs for EU MDD & AIMDD Devices

Today (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE titled “ADDITIONAL GUIDANCE ON TRANSITION FROM THE SECOND TO THE THIRD EDITIONS OF THE IEC 60601 FAMILY OF STANDARDS ON HEALTH CANADA’S LIST OF RECOGNIZED STANDARDS.”  HC has said that this guidance document will be posted on the HC website by around 1 APRIL 2012.  This document is much simpler and more straightforward than the Version 1.1 NB-MED EN 60601-1 3rd ed Implementation FAQ document.  (See more details on the NB-MED document by going to our 6 FEB 2012 posting on the subject.) 

Currently, HC recognizes both 2nd & 3rd edition of IEC 60601-1.  Based on what has been published, before this notice, after June 1, 2012 HC would only accept IEC 60601-1, 3rd ed. with the related Collateral standards (i.e. IEC 60601-1-XX that are aligned with IEC 60601-1, 3rd ed.) and related Particular standards (i.e. IEC 60601-2-XX that are aligned with IEC 60601-1, 3rd ed.).  This doesn’t work well as there are some Particular standards that aren’t aligned with 3rd ed., as of yet, or that have only recently (in the last year or so) been published by IEC and so many manufacturers haven’t had the time and/or resources to understand the requirements, do any redesign work, update to their labeling, update their Risk Management File to meet IEC 60601-1, 3rd. ed with any related Collateral & Particular standards, prepare the product for testing (including gathering all appropriate information [component info, etc.] to support the testing), test the product that will hopefully show that the manufacturer complies with all the requirements of the IEC 60601-1, 3rd ed. and the applicable Colateral and Particular standards.  That is unless the manufacturer has a lot of resources and are on top of the standards as they are being developed thru IEC and are starting on all this work prior to the applicable standards being published.

So, this HC guidance document sets out the following for the transition rules to be applied as of June 1, 2012:

Continue reading Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC 60601-1 & related 60601 Series of Stds