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EU MDR & IVDR Have Been Published in OJEU 5 May 2017

European Union


Update of May 5 2017 Addition of the Published Documents

“EU MDR & IVDR were  Published in OJEU TODAY Friday May 5, 2017″

Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:

Bassil Akra of TÜV SÜD some of the costs of this transition in his post on LinkedIn. It ain’t going to be cheap!

Back to our regularly scheduled post:

This Friday 5 May 2017 should be marked in your calendar or journal as a momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR & 5 years for the IVDR)!!  This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations.  If you haven’t started your transition planning strategies for your products & product families the pressure should be mounting quickly as there is so much to deal with for this transition time. Check out these resources for learning more about the MDR & IVDR. See below for some more details about the challenges you need to consider and START PLANNING for NOW (don’t wait)!

There is no grandfathering once the transition period ends for the applicable Regulation.  So, in 3 years and a day or so if you don’t meet the MDR or 5 years & a day or so if you don’t meet the IVDR you won’t be able to CE Mark your device and sell or distribute your medical or IVD device in the EU (& hopefully the UK which is in the middle of Brexit implications as UK will not be part of the EU by end of transition period).

We have talked about some of the challenges in the implementation of the MDR but here are more details to consider for your strategic planning:

  • New definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new & modified definitions.
  • Person Responsible for Regulatory Compliance: Identify personnel that is  responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.
  • Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) – Will register all devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations, & incident reporting.  Will manage all Unique Device Identifications and Single Registration Numbers (SRN).
  • Regulations are much more explicit now for the Quality Management System (QMS) & Risk Management System (RMS) requirements.  Beyond just what is in EN 13485 (ISO 1385:2016) & EN 14971
  • Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors & Manufacturers – Different Responsibilities depending on type of Economic Operators.
  • Traceability of Devices Between Economic Operators: Between all Economic Operators (wow that in itself can be huge!) and all the way down to the healthcare institutions & in some cases down to the patients devices used on.
  • Annex I now called Safety & Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI & SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation & Clinical Performance Evaluations requirements
  • Clinical Data: Much more prescriptive especially for higher risk class devices (class III & implantable devices) – Clinical Investigations needed in many cases now & restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III & implantable devices).
  • Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc.  The end result is fewer Notified Bodies & Notified Bodies with narrower scopes after the designation process.  Also, with the nexus of  the EU regulations, Canada’s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to complete these processes without hitting the edge or past the transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.

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.

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IEC 60601-1, 3rd ed. + A2 Anticipated ’19 – Annual Standards Trends Reports Web Special

Updated April 30 to extend Web Special til end of May ’17

Leo Eisner, the “IEC 60601 Guy” & Principal Consultant, of Eisner Safety Consultants attended several IEC SC 62A Maintenance Team (MT 28 & MT 30) and Working Group (WG14) meetings from March 22 – March 31, 2017 in Oslo, Norway and London, United Kingdom to start the work of reviewing the items agreed on (in Frankfurt Oct 2016) for IEC 60601-1, 3rd ed. + Amendment 2 (or ed. 3.2) for development and comment.

A2 of IEC 60601-1 & its’ related collateral standards are anticipated to be published by the end of 2019.  In only 2+ short years from now!!!!  Will you be ready?  We are offering a web special til the end of March May 2017 on our Annual Standards Trends Reports.  See more below.

A2 changes & collaterals changes may include any of the following:

  • safety gaps needing corrections,
  • known problems for regulatory bodies,
  •  inconsistencies within the standard,
  • technical errors, and
  • updates of standard references.

The above was the criteria for the ‘Short List’ vote on which items were agreed to in Frankfurt (Oct ’16) for A2 for IEC 60601-1 and it’s collateral standards.

Also, you need to be aware that the items that didn’t make it to the ‘short list’ are slated to be worked on for the 4th edition of IEC 60601-1 (the ‘long list’) which is scheduled to be published in 2024.  This will be a much more significant set of changes including potentially restructuring the standard and maybe even making the whole series a database standard.

Are you ready for changes coming for 60601-1, 3rd edition + Amendment 2 and 4th edition of IEC 60601-1?

We can help you stay up to date and ahead of the curve so you are prepared for these changes that are coming.  Check out our Annual Standards Trends Report as a fantastic resource that can save your company significant time and money (upwards of $100,000+).

To provide you an opportunity to receive the Eisner Safety Consultants Annual Standards Trends Reports for a significant discount of this year’s copy of these reports (publication between Late May to June 2017) we are offering a web special til the end of March May 2017 to give you the opportunity to learn from Leo about the Amendment 2 meetings in Oslo, Norway and London, U.K. The reports will include more details where these Amendment 2 changes are at and what these changes are.  If you want to stay ahead of your competitors, and save on the cost of standards committee membership fees, save on travel expenses, save time instead of sitting in these meetings, and getting the benefit of staying up to date on medical electrical equipment & systems (MEE&S) standards and home use MEE&S standard consider this amazing deal:

Eisner Safety Consultants

Annual Standards Trends Reports on MEE&S &

Home Use MEE&S Options

Get This Year’s Report(s): May/June 2017 Annual Standards Trends Report (ASTR) Options:

Normally priced at $1,997.00 Web Special $1,597.00 for the:

May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTR OR

May/June 2017 Home Use MEE&S ASTR

Normally priced at $2,997.00 Web Special $2,497.00 for the:

Bundle pricing of both the May/June 2017 MEES & Home Use MEE&S ASTRs

Get This & Last Year’s Report(s): March 2016* & May/June 2017 ASTRs Options:

Normally priced at $2,397.00 Web Special $1,997.00 for the:

March 2016* & May/June 2017 Medical Electrical Equipment & Systems (MEE&S) ASTRs OR

March 2016* & May/June 2017 Home Use MEE&S ASTRs

Normally priced at $3,697.00 Web Special $2,997.00 for the:

Bundle pricing for all 4 Reports – March 2016* & May/June 2017 of both MEE&S & Home Use MEE&S ASTRs

* = MAR ‘16 ASTRs issued as of MAR ‘16 with no updates for these ridiculously low rates.

If you need help with IEC 60601-1 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 and considered the ‘IEC 60601 Guy’ by many of his clients and associates.

 

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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.

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

ESCLogoC72

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

 

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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.