Thursday, May 18, 2017

Seminar Topics:

• Current guidance around Medical Electrical Equipment for FDA 510(k)s & Health Canada
• IEC 60601-1 series:
  • • Intro to IEC 60601 -1 series with Collateral & Particular Standards
    • Design & compliance to IEC 60601-1 3rd edition (including AM1)
    • Changes to the 60601-1 series and supporting standards: Updates on what’s new and draft documents that may impact your Compliance strategy
• ISO 14971:2007 Risk Management File (RMF) Overview

See the detailed Seminar Agenda.

Sign-up for Workshop Closed

Bio’s of Presenters

Leo Eisner, principal medical device product safety & regulatory consultant of Eisner Safety Consultants.
Leo’s firm specializes in helping medical device manufacturers through product safety, international regulatory and quality system processes. He has been called the “IEC 60601-1 Guy” by his clients and associates. Leo’s focus is on active medical electrical equipment including home use and wearable devices. Leo is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx standards), convener of IEC SC62D JWG9 (IEC/ISO80601-2-58) & a committee member of US TAG for TC62, SC62A, SC62D, & SyC AAL (Active Assisted Living System Committee – Home use medical and non-medical devices). Leo is a registered professional engineer in safety and has over 30 years experience in product safety. Leo is a member of RAPS, AAMI, ASQ, & IEEE. He’s manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment.

Peter Keith P.Eng, Senior Engineer and Technical Certifier at TÜV SÜD Canada Inc.
Peter is the lead medical services engineer at TÜV SÜD Canada with 10 + years of safety evaluation and regulatory experience, specializing in safety certification of medical and laboratory equipment such as hospital beds, ECGs, therapeutic lights, TENS, Lasers and more. Peter has participated on technical committees such as CACES (Canadian Advisory Committee on Electrical Safety) and assisted on the development of CSA SPE – 3000:2015. Peter is a licensed professional Engineer in Ontario and has evaluated over 400 medical and laboratory projects and given various seminars on regulatory and standards compliance.

Seminar Agenda:

Meet and Greet (9:00 AM)

Introduction to TÜV SÜD Canada & Presenter’s Backgrounds (9:15 AM)

Current US & Canadian Guidance for Medical Electrical Equipment
(9:30 to 10:45 AM)

Break time (15 Minutes)

Intro to IEC 60601-1 series (11:00 to 12:00 PM)

Q & A for Morning Session (12:00 – 12:15 PM)

Break for Lunch (lab tour and test demo) (12:15 to 1:30 PM)

Design and Compliance to 60601 – 1 3rd edition (1:30 to 2:30 PM)

Upcoming Standards Changes and Updates Related to 60601 Series
(2:30 to 3:30 PM)

Break time (15 Minutes)

ISO 14971:2007 Risk Management File (RMF) Overview (3:45 – 4:45 PM)

Q & A

Rob Packard, a Quality System & Regulatory expert of Medical Device Academy, was gracious enough to allow us to post these articles he wrote recently on Canadian Medical Device Regulations.  Thx Rob!

The first article is a hypothetical case study that explains the process of obtaining a Health Canada Medical Device License.

The second and third articles are a 2 Part Series on the 11 Steps to Obtaining CMDCAS Certification.

• Part 1 focuses on the process of verifying the classification, selecting a registrar and obtaining a quote for CMDCAS certification. 
• Part 2 focuses on the process of updating the quality system (Licensing, Mandatory Problem Reporting, & Recall Procedures), finding a distributor, training your staff that touches parts of the quality system that are impacted by the CMDR, conducting internal auditing to applicable sections of the CMDR, going thru the CMDCAS certification audit, and lastly if applicable your Submission of your License Application. 

Enjoy the article!

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:

1. If there is no Particular standard that is directly applicable to the device, it should conform to IEC 60601-1:2005 and its applicable Collateral standards.
2. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1:2005 was published by IEC before June 1, 2009, then the device should conform to IEC 60601-1:2005 and its applicable Collateral standards in addition to the(se) Particular standard(s).
   NOTE: If there are multiple Particular standards that apply to the device you will want to take the latest Particular standard publication date and if that is still before June 1, 2009 use this item 2.  If it is after June 1, 2009n then use item 3.
3. If there is a Particular standard(s) that is directly applicable to the device and the version that aligns with IEC 60601-1: 2005 was published by IEC after June 1, 2009, a three year transition period from the date of publication by IEC will apply.  During this transition, HC will accept conformity to both editions and related Collateral standards (and both will be listed on HC’s List of Recognized Standards).  
   Refer to NOTE in item 2. 

These transition rules will not be applied retroactively, meaning that if you have a HC Medical Device License for your product and you used IEC 60601-1, 2nd ed. unless there is a significant change to your product that impacts the characteristics of IEC 60601 series of standards you won’t have to retest to IEC 60601, 3rd ed and submit for an Amended License Application.  HC doesn’t require meeting the ‘state of the art’ in the same sense as is stated in the Essential Requirements of Annex I in the EU Medical Device Directive (MDD) or similarly in the Active Implantable Medical Device Directive (AIMDD) so the manufacturer only needs to submit to HC when they have a new medical device that requires a HC license or the manufacturer has to amend their HC medical device license because they have significant change(s) to the product(s) that impact characteristics addressed by the 60601 series of standards.

You still can submit for a HC Medical Device License to 2nd edition of IEC 60601-1 before June 1, 2012 but you will need to make sure it is shipped prior to June 1, 2012.

Standards are voluntary per the CMDR so if you have test data to IEC 60601-1, 2nd ed. and the applicable Particular & Collateral Standards you still could submit this test data to HC after the Transition Rules (items 1 – 3 above) prescribe IEC 60601-1:2005 & applicable standards.  The mfr would have to provide a summary of the differences in the testing compared to IEC 60601-1:2005 and provide a rationale to demonstrate that these differences do not affect the validity of the testing in demonstrating of the device’s safety and effectiveness.

The guidance document does state that HC reserves the right to require additional testing deemed necessary to demonstrate safety and effectiveness of any device. 

A very important note is stated near the end of the document which says:

” A Medical Device Licence issued by Health Canada provides authorization to import or sell a medical device in Canada and is evidence that the device meets the requirements of the Medical Devices Regulations.  Manufacturers are reminded that Provincial or Territorial electrical safety requirements are separate and distinct from the requirements of the Regulations.  For further information regarding these requirements, contact the applicable regulatory authorities.  A listing of some such authorities is available at: http://www.csa.ca/cm/ca/en/community/electrical/regulators.”

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.