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EU MDR & IVDR – Final Versions – Are You Ready (Updated 7, 12, & 17 March ’17)

European Union and Europe countries including France Germany Italy and England surrounded by blue ocean with three dimensional yellow flag stars on a blue grunge background.

Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources.  Check out our updates in this LinkedIn Article.

Updates are all underlined:

Mar 7, ’17 updates:

* addition of the EU Council vote & date of release of final text

* an important change that manufacturers will need to deal with, and

* addition of 4 resources to list of helpful resources

Mar 12, ’17 update: add in Table of Contents LinkedIn Article

Mar 17, ’17 update: RAPS Article by Rod Ruston

Our original post was on March 1, 2017 is titled EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

Medical Compliance Seminar May 18, ’17 – Toronto, Canada

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MEDICAL COMPLIANCE SEMINAR
Thursday, May 18, 2017                                    Global EMC INC 3       TUV Canada logo

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.

To guarantee your spot, please register with Tina Lee at (Tlee at tuvcanada dot com) and pay either in US or Canadian Dollars thru our Paypal links below.
Fee is $75 (Canadian$ per person) or $56 (US$ per person)

Location: 11 Gordon Collins Drive, Gormley, Ontario, Canada L0H 1G0.

Purchase 1 or 2 Person Registrations here:

In Canadian Dollars  Buy Now Paypal btn_buynowCC_LG

 

In US Dollars  Buy Now Paypal btn_buynowCC_LG

 

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 606011 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/ISO80601258) & 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 SPE3000:2015.  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

 

EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon

European Union and Europe countries including France Germany Italy and England surrounded by blue ocean with three dimensional yellow flag stars on a blue grunge background.

Final texts of the EU MDR & IVDR (R = Regulation) have been released recently and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period.  You should be starting your quality planning now if you haven’t already and start talking with your Notified Body to make sure they will still be notified for your specific type of device/technology as many Notified Bodies have lost their notifications and more are sure to fall or fail.The reason for this change from the MD & IVD Directives is because of the PIP Breast implant scandal and issues with implantable metal hips.

Some of the changes manufacturers will have to deal with include:

*Quality Management Systems
*Clinical Evidence Requirements
*Authorized Representatives Requirements and Liability
*You may need to change Notified Bodies if their scope changes during the designation process
*Need to prepare and implement for Unique Device Identifiers (UDI), starting with the highest risk class
*Person responsible for regulatory compliance in your company – minimum requirements
*Classification rules will change & some devices that are not considered medical device currently will fall under the MDR
*Classification rules will impact IVDs significantly under the IVDR
*Updates to post market surveillance & vigilance requirements
*Economic operators in the supply chain will have some changes to the obligations per the MDR or IVDR

Here are some resources to share with you:

Regulatory Focus (RF) by RAPS article, updated 23 Feb 2017, “Final Versions of EU MDR, IVD Released, Voting Begins Next Month”

BSI Blog post titled “Are you set for the Medical Devices Regulations?

greenlight.guru Webinars on How to Prepare for the New EU Medical Device Regulations (MDR) and How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

For the following 3 BSI White Papers* please select the title from the BSI White Paper webpage.

BSI’s white paper* on the MDR “Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?”

BSI’s white paper* on the IVDR titled “How to prepare for and implement the upcoming IVDR – Dos and don’ts”

BSI’s white paper* on the MDR & IVDR draft text (article updated Oct 2015) titled “UPDATED: The proposed EU regulations for medical and in vitro diagnostic devices”

BSI webpage for white papers* has additional white papers on medical devices / IVDs and quality system requirements.

One of my favorite blogs to follow on the MDR changes is Erik Vollebregt’s Medicaldeviceslegal.com blog.  Erik does an excellent job providing really great information on the subject and keeping his finger on the pulse of the issue at hand.

* Note, through out the BSI White paper series I have had the honor of being on the Advisory Panel to help shape the series and review each of the white papers to provide my years of experience in the medical device industry and the regulatory world.

De-notification of EU Notified Bodies under MDD

The number of EU Notified Bodies (NBs) under the MDD has dropped from about 80 to less than 60 because of the increasingly more stringent NB requirements.  Are you sure your Notified Body scope still covers your products or are they de-notified?  The French Competent Authority (National Agency for Safety of Medicines and Health Product [ANSM]) in late 2016 published an Information Bulletin and an FAQ for manufacturers on how to adjust to the situation when a notified body is de-notified or terminates its business. Swissmedic (Swiss Agency for Therapeutic Products) also came out with a similar notification in December 2016 (Switzerland is not part of the EU but part of EFTA which is closely linked to the EU is some ways). The two Competent Authorities notifications are similar but not identical.  Expect more Competent Authorities to come out with similar recommendations.

Also, what is going to happen when the Notified Bodies apply for designation under the MDR and when will your Notified Body get approved for the designation under the MDR.  The designation process may take a year or more and some NB’s may not get designated for all they expect or they may decide to shutter their doors, among other scenarios.  So, make sure to read the notifications in the above paragraph and also stay in close contact with your NB to make sure you don’t get left in the cold without a proper NB for your product lines.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

Rapid Growth in Home Use of Medical Devices Requires New Standards

Read the recent IEC e-tech magazine article (in Oct 2016 e-tech) titled ‘Rapid growth in home use of medical devices requires new standards‘.  It discusses both medical and non-medical home use devices and where standards development is going.  Also, it discusses wellness devices which can be a medical device or a non-medical device depending on its intended use, in some countries.

‘IEC work underpins fast growing support for home use of health and wellness devices’ – IEC e-tech article quote

Dexcom G5 Mobile is a compact continuous glucose monitoring (CGM) system that can provide accurate, real-time glucose readings every five minutes for people with type 1 or type 2 diabetes on mobile devices (Photo: Dexcom, Inc.)

Dexcom G5 Mobile is a compact continuous glucose monitoring (CGM) system that can provide accurate, real-time glucose readings every five minutes for people with type 1 or type 2 diabetes on mobile devices (Photo: Dexcom, Inc.)

IEC has published the above article that I originally wrote back in August 2016 (The above IEC article is written with a slightly different spin on it) for

InCompliance Aug 2016 Cover Pg

photo courtesy of In Compliance Magazine, Aug 2016


InCompliance Magazine
titled “Home Use Medical and Wellness Devices”.
Both articles are worth a read as you will learn different information from each one.

I hope you enjoy the two articles and if there is anything I can answer please contact me at either Leo at EsnerSafety dot com or 503-244-6151.

15 Steps to Get IEC 60601-1 Approval – Webinar

Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a Webinar on the 15 Steps to Get IEC 60601-1 Approval on December 13, 2016 1PM ET/10AM PT.  Sign-up now for the limited live seating of the free webinar.15 Steps to Get IEC 60601-1 Approval Webinar

Speed your time to market by following the step-by-step instructions that I will discuss in this free, 90 minute webinar, so you can obtain your product certification to IEC 60601-1 series of standards quicker.

I will walk you through the steps to success for product testing by a certification agency (like UL, TÜV, BSI, Intertek, etc.) to the IEC 60601-1 series of standards on medical electrical equipment and systems.
Learn from the expert the mistakes others have made that have slowed down their certification process (and how you can avoid them).
Take proactive steps so your product doesn’t need to get redesigned after testing starts.

Take Aways from this Webinar:

  • The IEC 60601-1 standards series & if they apply to your product.
  • What you need to know to classify your products to the IEC 60601-1 series.
  • What is an isolation diagram and how does that help me with my design?
  • Understanding the importance of the Risk Management File and Essential Performance requirements.
  • Determine the applicable tests for your device.
  • What are the marking and labeling requirements for the device?
  • Know your critical components.
  • What pre-tests to run and what’s not worth testing?
  • What samples are needed for testing?
  • Resources to help with this process and ways to reduce the paperwork off your backs.  Get your free sample of Our Annual Standards Trends Report. Learn more about our Annual Standards Trends Report service.

If you want to get a prelude to this webinar listen to the podcast that discusses some of the Take Aways of this presentation.

About the presenter:

This webinar is being lead by Leonard “The 60601-1 Guy” Eisner, founder and principal consultant at Eisner Safety Consultants.

Leo is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives.

Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz Imaging and was a Senior Product Safety engineer at TÜV Product Service. Prior to that Leo worked in a cross section of groups at U.L. for 9 years.

Copy of Copy of greenight.guru

About greenlight.guru

greenlight.guru is the only Quality Management Software built exclusively for the unique needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit their home page to learn more.

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About Eisner Safety Consultants

Eisner Safety Consultants provides affordable, on-time product approvals via safety & regulatory agencies to medical device companies. We provide assistance with U.S., Canadian, European, & other international regulations. Click here to learn more about our services we offer.