COMMISSION IMPLEMENTATION DECISION M/575 was issued 14 April 2021: This is a list of standards the EU Commission is hoping to Harmonize under MDR and IVDR.  One of the issues is the HAS consultant has issued a negative assessment on EN ISO 14971 which the CEN/CLC JTC3 leadership is working with the HAS consultant to address the issues and to draft acceptable European annexes so Harmonization can occur for the standard.  Many of the standards on the list in M/575 reference to EN ISO 14971 so it is highly likely that CEN and CENELEC will reject this newest version of the EU Commission Standardization Request again and we won’t have any Harmonized Standards by the Date of Application (26 May 2021) for the MDR which will cause lots of problems for manufacturers and Notified Bodies and cause more delays for the MDR & likely even for the IVDR I’m sorry to say.  Also, the MDCG 2021-5 “Guidance on standardisation for medical devices” doesn’t seem to clarify when harmonized standards are not published through the Offical Journal of the EU what to do.  In section 3.1 mentions Harmonized standards are voluntary with respect to the MDR & IVDR as they were for the MDD, AIMDD, & IVDD.  The closest the MDCG gets to it is to use the “State of Art” standards approach in section 3.5.

Another important observation is all the newest versions of the General & Collateral IEC 60601 Standards that were issued Summer of 2020 (EN versions were issued later in the year) are listed in Annex I of the EU Commission Standardization Request as the deadline to adopt these standards by 27 May 2024 — These are EN 60601-1, ed. 3.2; EN 60601-1-2, ed. 4.1; EN 60601-1-3, ed. 2.2; EN 60601-1-6, ed. 3.2; EN 60601-1-8, ed. 2.2; EN 60601-1-9, ed. 1.2; EN 60601-1-10, ed. 1.2; EN 60601-1-11, ed. 2.1; & EN 60601-1-12, ed. 1.1 – The Particular Standards EN 60601-2-XX or EN ISO 80601-2-XX listed are primarily based on the previous versions of the General & Collaterals of IEC 60601 standards on the M/575 list so this will likely cause conflicts vs the listed new standards mentioned here.

Follow the full discussion and updates to this post on LinkedIn

Confused this is what Eisner Safety Consultants experts deal with all the time for countries for these and many other standards, regulations, laws, directives, and more. Leo Eisner is an expert on standards development and sit on many standards committees. Let us help you through this process. Need help with Essential Performance. Feel free to schedule a call with Leo www.EisnerSafety.com/Schedule-Call/ or contact Leo at Leo@EisnerSafety.com or through our contact form at https://eisnersafety.com/contact_eisner_safety/.

EU Commission promised 20 Designations

12 Notified Bodies Designated to MDR (9) & IVDR (3*)

*All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective.

2 NB’s are likely to be “de-designated” (not sure of the proper term yet) end of Jan 2020 based on Brexit. That would be BSI Assurance UK Ltd.

The EU Commission has promised more NB’s to be designated in the 1st quarter of 2020. Let’s hope this will get us to at least 20 NB’s.

Two last-minute Christmas presents were BSI Group Netherlands IVDR and Medcert’s MDR designations on 24 & 25 Dec respectively.

Few products have been CE marked to the MDR that have gone through a NB review process. Typically the process is taking at least a year or more. Your quality system and product files need to be reviewed.

You are running out of time with the transition only about 5 months away.

Not all NB’s have full coverage of the NANDO codes so check the NANDO database (MDR link) or check with your NB.

May you have a Happy, Safe, & Prosperous New Year and may your medical device be CE Marked under the MDR in the New Year.

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

• Medical Device Regulation (EU) 2017/745 and
• In Vitro Diagnostic Regulation (EU) 2017/746

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.

Let’s start with some really big news!!!

It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of IEC 60601-1 will be published.

If you want more details about what is happening with the IEC 60601-1 changes so you can plan for these big changes consider our Standards Annual Reports on the Medical Electrical Equipment Standards and/or Home Use Medical Electrical Equipment Standards which goes over what is happening with draft and newly released standards and technical reports.

We are offering a “Special April 2016 Flash Sale” on the Standards Annual Reports discount for new customers and a super deep deep discount pricing for our loyal customers

We have broken this post into national areas

• USA FDA
• EU MDR & RoHS-2
• IMDRF Update
• Brazil
• China CFDA & China RoHS-2
• Russia
• Home Health Care Articles
• Standards Update
  • So much is going on with ISO 13485:2016 (links to details below) – “Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes”.   Also, we keep adding to the post on ISO 13485:2016 is Now Available – Start Planning Your Transition.  Come and find all the great resources we link you with and also read the post to learn the steps to start your transition planning..
• New Strategic Services to help your Company in 2016 & into the future
  • Strategic Reports on Future Development of Standards that impact your Medical Devices – Flash Sale for April 216 – this service helps you strategize your product development process to know in advance when changes to standards may impact your devices and save you a lot of money in the long run.  A great example is will you be ready for the major changes that IEC 60601-1-2, 4th ed. will place on your products?  What is going on with changes in process for IEC 60601-1 3rd ed. + Amendment 2 and the future 4th ed.?

  • BIG PRICE DROP ON OUR

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Now only $900/yr for our Base subscription level or $1650/yr for a Full subscription level.  These are sale prices so get them while they last.  We have updated our service to make it more affordable but with the same information except we removed the annual report.  You get a better annual report in the above service that is much more detailed than we were offering with our db.

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USA
FDA – Are you aware of the many issues with  FDA? Here are some of the relevant issues to keep up on

1) FDA Device Regulations, a few of which are coming later in 2016.  The FDA has a transparency initiative known as the Transparency Results Accountability Credibility Knowledge Sharing (TRACK).  The database shows what is expected for upcoming proposed and final rule making.  A couple of the items on that list are noted here. The dates in the db don’t guarantee the release of those rules. More information on the process the FDA follows to issue Rules & Regulations.

a) Use of Symbols in Labeling

Abstract “The purpose of this rule is to allow for the inclusion in device labeling of stand-alone symbols established as part of a standard developed by a national or international standards development organization, provided that such symbols are explained in a symbols glossary that is included in the labeling for the medical device. The rule also revises prescription device labeling regulations to authorize the use of the symbol statement “Rx only” on the labeling of prescription devices.”  One of the standards referenced is AAMI/ANSI/ ISO 15223–1:2012, Medical Devices— Symbols to be Used With Medical Device Labels, Labeling and Information to be Supplied, Part 1, General Requirements. The proposed rule announcement was published in the Federal Register on April 19, 2013.  The final rule is scheduled for March 2016 but as mentioned above the dates may not always be met.

b) Declaration of Labeling for Home-Use Devices

Abstract: “The purpose of the proposed rule is to require certain medical device establishments listing home-use medical devices to submit, in electronic format, the label and package insert of such certain medical devices listed with FDA. FDA intends to make the information from the submitted labeling accessible by the public through a focused Internet site.”  This is in the proposed rule stage and is expected to be issued around May 2016 if on time.

c) Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

Abstract: “The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X- ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.” This is in the proposed rule stage and is expected to be issued around July 2016 if on time.

2) FDA continues to issue lots of Draft & Final Guidances.  Here are some relevant ones since our last update in Jan 2016:

a) Draft Guidance (Issued on January 26, 2016) – Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff

b) Draft Guidance (Issued on February 3, 2016) – Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff

c) Draft Guidance (Issued on February 3, 2016) – Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

d) Draft Guidance (Issued on February 3, 2016) – Linked with Item 2)b) Guidance. This Guidance provides a List of the Highest Priority Devices for Human Factors Review per FDA.  As this is a draft Guidance this list is not final but one I would highly recommend you follow, if you are submitting a product that is on this list, for a regulatory approval thru the FDA. – List of Highest Priority Devices for Human Factors Review – Draft Guidance for Industry and Food and Drug Administration Staff

e) Draft Guidance (Issued on February 9, 2016) – Display Devices for Diagnostic Radiology – Draft Guidance for Industry and Food and Drug Administration Staff

f) Final Guidance (Issued on March 7, 2016, the draft of this document was issued on January 27, 2015) – Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails – Guidance for Industry and Food and Drug Administration Staff

g) Draft Guidance (Issued on March 7, 2016) – Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes – Draft Guidance for Industry and Food and Drug Administration Staff

h) Final Guidance (Issued on March 22, 2016, the draft of this document was issued on June 29, 2015) – Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices – Guidance for Industry and Food and Drug Administration Staff

3) FDA national evaluation system for medical devices announcement on 4 April 2016: “Establishing a national evaluation system for medical devices is one of CDRH’s 2016-2017 strategic priorities. A national evaluation system is a collaborative system that monitors, links, and analyzes real-world data from many different sources—including clinical registries, electronic health records and medical billing claims— across the medical device landscape with the goal of better understanding how medical devices perform. By harnessing such real-world data using state-of-the-art techniques, such a system will provide information that not only contributes to regulatory decisions, but also promotes device innovation, and importantly provides timely and meaningful information directly to patients and their physicians.

Today, as an outcome of a cooperative agreement with FDA1, the Duke-Margolis Center for Health Policy published its vision on a coordinating center for such a system. “Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System” describes expectations for a national evaluation system’s Coordinating Center (you may recall that the planning board called for a Coordinating Center in its February 2015, “Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System”). The Coordinating Center will guide the future development and implementation of a national system.

Today’s publication is an important step toward building a national evaluation system. For more information about a national evaluation system, please visit the FDA’s National Evaluation System webpage.”

4) FDA on 4 April 2016 published in the Federal Register their latest updates to the list of Recognized Consensus Standards with some new additions, some updates and some withdrawals.  This is List 041 as published in the Federal Register and has some important updates that include finally adding in the IEC 61010-1 Lab Equipment standard among many other changes.  As of April 5, 2016 the Recognized Standards database has not been updated with these new standards updates.

5) Updated FDA Web Page on “Interference between CT and Electronic Medical Devices“. Last Updated on 31 March 2016.

6) Updated FDA Web Page on “eMDR System Enhancements“. Last Updated on 31 March 2016.

Part of the Standards Reconnaissance Database Service will include a listing of current FDA CDRH Guidances Final & Draft plus we will be adding in the Canadian and Europe Guidances, as well. We will be launching this stage 2 in the next month or so. Learn more about this db.  If you would like a live demo of the db please contact me directly at Leo@EisnerSafety.com.

EU  

Updates on the Draft EU Medical Device and the In-Vitro Diagnostic Regulations

This is a moving target but there are some really good resources for updates on these draft Regulations and my favorite sources to find out info on this topic are Erik Vollebregt’s Blog called www.medicaldeviceslegal.com, the MedTech Europe website (MedTech Europe is an alliance of European medical technology industry associations. It currently has two members: EDMA, representing the European in vitro diagnostic industry; and Eucomed, representing the European medical devices industry), and BSI’s updated white paper on “The proposed EU regulations for medical and in vitro diagnostic devices: An Overview of the likely outcomes and consequences for the market” (You need to fill out a form to download the White Paper but it is totally worth it). Anything new with Erik’s & MedTech Europe’s sites of late:

1) On Erik’s site he has done a post titled “Medical devices M&A – data protection” and it focuses on data protection in the EU is a major issue that needs to be addressed seriously and hopefully early enough on in a company’s history so when you are at the Mergers and Acquisition stage you aren’t trying to gigger with it at this late date as it could devalue your sale of your company.
2) In our previous Global Update MedTech Europe wrote about Advocacy activities related to the MD & IVD Regulations. It also looks at the past and future work to be done.

EU RoHS-2 – Courtesy GreenSoft Technology, Inc.

The Bulk of RoHS-2 Exemptions Expire This July: Be Prepared!

Renewal Requests Submitted for Large Number of EU RoHS-2 Exemptions

IMDRF Update  

IMDRF Offers Progress Updates at March Meeting in Brazil – Excellent update by RAPS Regulatory Focus which discusses the various updates by the Regulators including on the Medical Device Single Audit Program (MDSAP) and it’s progress, presentations on the topic of Software as a Medical Device, and current work summary for IMDRF (See below listing).

Current IMDRF work items include:

1. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

3. Software as a Medical Device (SaMD): Clinical Evaluation

4. Regulated Product Submission (RPS)

5. Patient Registries

6. Adverse Event Terminology

7. Good Regulatory Review Practices – Competence and Training Requirements for Pre-market Reviewers and Product Specialist

 Brazil IEC 60601-1-9 required End of 2016 Are You Ready?

Refer to our recently released blog post dated 6 April 2016. 

China  

CFDA – (China Food & Drug Administration) – Articles Courtesy CIRS-MD

Summary of Medical Device Guidelines of 2015 in China – In order to standardize the supervision and strengthen the guidance of medical device registration, CFDA had conformed and released a series of Medical Device Guideline in 2015. These guidances will help you prepare your submission dossier and for registration evaluation. What to include inside Guideline? and What guidelines did CFDA release?

“Guideline for Medical Device Good Supply Practice On-site Inspection”Interpretation – In order to strengthen the supervision and management of medical device distribution, standardize and guide the Good Supply Practice (GSP’s) on-site inspection, CFDA has formulated the Guideline for Medical Device Good Supply Practice On-site Inspection, issued Oct.15th , 2015. How to deal with the on-site inspection, and what is the criteria of inspection result determining?

“Administration Regulations for Instruction and Label of Medical Device” Interpretation – CFDA has put Administration Regulations for Instruction and Label of Medical Device (click on the Documents tab to get the regulations text) into effect on 2014.10.01, and issued the interpretation of this regulation to help enterprises to have better understanding of this regulation on 2015.02.05. What are the requirements of medical device instruction and label and their content? what are the contents forbidden in the instructions and labels?

“Administrative Measures for Quality Supervision on the Use of Medical Devices” – On Oct 23th, 2015, China Food and Drug Administration (CFDA) has promulgated Administrative Measures for Quality Supervision on the Use of Medical Devices to strengthen the management of the use of medical devices. According to the regulation, medical device use parties shall set up appropriate quality management system, which includes two aspects: one involves purchase, acceptance check and storage; another one involves use, maintenance and transfer.

CFDA 2015 Medical Device Regulatory Data Analysis – CFDA has released the 2015 Food And Drug Regulatory Statistical Annual Report, which announced the objective data about health food, drug, medical device and cosmetic. The data involved with manufacture, distribution, registration, and so on. This article discusses medical device regulatory data from 2012 to 2015 which involved with the number of Medical Device Registration during 2011~2015, as well as medical device manufacturers and distributors.

Final China RoHS-2 Regulation Published – Courtesy GreenSoft Technology, Inc. 

Russia   

Recently I found an English version of the Roszdravnadzor* website (Federal Service for Surveillance in Healthcare).

*”Roszdravnadzor executes the state supervision over observance of the Russian Federation legislation regarding the state supervision over quality and safety of medical practice, compliance to the procedures of healthcare provision and the standards of medical care by institutions and individual medical practitioners.

Home Health Care Articles Courtesy of HomeCare magazine

The Homecare Technology Race

Keeping Seniors in Their Homes with Technology

The Future of Home Health

Standards Updates  

ISO 13485:2016 – Medical devices. Quality management systems. Requirements for regulatory purposes

This segment has been update since the Publication of the ISO 13485:2016 standard.

The standard has been published as an International Standard. It was published late February but the official date on the ISO version of the Standard is March 1, 2016.
A white paper  by the Working Group WG1 of the Technical Committee TC210 proposed that there be a three (3) year transition period.  From what I have seen this seems like it will be followed but I would recommend that you check with your Notified Body or Certification Body that you are using for your Quality System Certificate to ensure you are on the same time schedule they are.

The proposal from the white paper says:
This phase concerns the co-existence of the availability of accredited certification to ISO 13485:2003 and ISO 13485:2016. It is recommended to ISO TC 210 that this phase last for three years, during which time users will have to update their quality management systems to meet the requirements of ISO 13485:2016 to an accredited certificate. It is recommended that the users of ISO 13485:2003 work with their certification bodies or registrars to schedule an upgrade audit at a convenient time within the transition period.
It is recommended that:

Two years after the publication of ISO 13485:2016 all accredited certifications issued (new certifications or re-certifications) will be to ISO 13485:2016.
Three years after publication by ISO of ISO 13485:2016, any existing certification issued to ISO 13485:2003 will not be valid.

If you are ready to start planning your transition to ISO 13485:2016 enjoy our blog post on the subject with lots of additional resources that have been added since the original post.

Find out more about this standard from a presentation done back in Feb 2016.  You can get the recording and the slide deck.  You’ll learn how to prepare for the coming regulatory changes, get a general overview of the standard & its most significant changes, and a lot more. Our strategic partners greenlight.guru will ran this free Webinar titled “Understanding the Changes to ISO 13485:2016”. It was presented by Mark Swanson who is a member of the ISO 13485 working group. Click this link to get the on-demand recording.
Also, if you want more info on the standard now you can listen to a podcast on the subject too.

New Strategic Services to help your  

Company in 2016 and into the future

Strategic Reports on Future Development of Standards that impact your Medical Devices

April 2016 Flash Sale on Reports for New Customers & Existing Clients* **

For most companies it is quite expensive to have one of your employees be a committee member for the development of standards.  For example a US company would have to pay annual dues to ANSI & AAMI (AAMI’s dues are based on your Gross profits) for the company & the employee, pay for the travel costs to the meetings, and there is a significant time commitment of the employee for the meetings & additional time commitment expected of committee members to be involved in the standard development process.
There is an alternative to this expensive venture for medical device companies that design & market electrical medical devices.  I, Leo Eisner, can be your eyes and ears so you can learn what the plans are for new and existing standards without the extensive resource and financial commitment to your organization.

These reports are available and if you are a current or past client you get an extra special discount (See * & **).  For the month of April 2016 we have slashed prices for these reports for new customers and deeply discounted the reports for current (project open already) and past clients (See * & ** notes for client rates).

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New Customers can purchase a copy of these reports now. Leo at EisnerSafety dot com or call us at 503-244-6151.

* Current & past Eisner Safety Consultants Clients are eligible for a $1,000.00 (US$) discount if you grab this deal for one reports during April 2016.  So, one report is only $1,500.00 (US$) to my loyal customers during April 2016.  Payment must be by check or bank wire to receive this discounted price.  Please contact us to arrange for this special discount.

** Current & past Eisner Safety Consultants Clients are eligible for a $2,000.00 (US$) discount if you grab this deal for both reports.  So, both reports are only $2,500.00 (US$) to my loyal customers during April 2016.  Payment must be by check or bank wire to receive this discounted price.  Please contact us to arrange for this special discount.
Please contact me with any question on this service at Leo@EisnerSafety.com or 503-244-6151

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Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for your organization to keep up with all the different data sources we have the solution for you at a reasonable price. A Standards Reconnaissance Subscription Service to help medical electrical device manufacturers keep up to date on all the changes that occur for these documents so you are prepared for future changes well ahead of the norm and you are able to stay up to date on your list of standards. The focus of this service will be on the documents for medical electrical equipment & systems (MEE&S = IEC TC 62, SC 62A – 62D) and home use medical electrical equipment & systems (Home Use MEE&S = IEC Active Assisted Living System Committee (IEC AAL SyC) and any other Home Use medical electrical equipment documents from the IEC TC 62, SC 62A – 62D including IEC 60601-1-11 Home Use Environment).

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• List of standards publishers & associated country (this will cover 50+ countries) [includes free service level],
• List of Medical Device Regulators with their websites, if available, for a selection of countries including all the of EU & EFTA countries.  We plan to expand this to include all countries in the world by the end of Stage 2 (below),
• Guidance Documents – Guidance documents that the regulatory bodies use for their national regulatory systems. Like for the US, Canada, & Europe. They will be added sometime after going live by end of stage 2 or 3 (see below).

Once the db goes live you can check out how the db works by accessing the free level of service to view a few examples of current standards (about 10 to 15). With the free service level you will be able to use most of the db features set other than obtaining reports, the update notification service, but you will not have access to List of Medical Device Regulators db of Guidance documents db.

Pricing starts at only:

• $4,500/year for Base Entry Subscription (2 reports per year and select either MEE&S or Home Use MEE&S part of db),
• $6,500/year for Mid-Level Subscription (4 reports per year and full access to db), or
• $9,000/year & up for Premium Subscription (2 personalized reports for your company’s needs based on conversations with Leo Eisner, 2 reports per year from the Premium Subscription level, and full access to db)
  All payments to be paid in US$ only.

We plan to go live with the db by the end of Sept 2015. Since we will be releasing the db in stages the early adopters will get a discount (20%) for the first annual subscription cycle and additionally we will throw in extra months to your subscription commensurate with how early you subscribe.  The earlier you subscribe the more free months will be added to your first yearly subscription for no additional charge.

Please reserve your spot by September 28, 2015 for this db subscription service and to guarantee a discounted first year price and to obtain extra months added for free. To reserve your spot for the Base entry or the Mid-Level Subscriptions please arrange a $750.00 (US$) deposit and for the Premium Subscriptions please arrange a $1,500.00 (US$) deposit. Contact us to arrange for deposit.

There will be a couple stages for the release of information for the db.  We plan on continual updates over time to provide a really valuable resource and continually make it better. The first stage will be complete prior to the official release of the db which will include all the updated information for the IEC based MEE&S & Home Use MEE&S documents including updates on the small number of joint IEC/ISO documents.  Stage 2 will be initiated just before the release of the db, which will include updates for the US, EU, and Canadian versions of the IEC & IEC/ISO MEE&S and Home Use MEE&S documents and IEC/ISO joint documents. We plan to have stage 2 completed around Jan 2016.  Stage 3 will include updated information adding in the supporting medical device (non-medical-electrical) documents you need for your regulatory submissions such as ISO 10993 series of standards, ISO 15223-1, etc.  This stage will initiate with the non-medical-electrical standards for IEC and ISO and in the future we will add other Standards Developers.  We expect to start on stage 3 around Jan 2016 and have not yet scheduled it’s completion.

Please contact Leo Eisner to find out more details about this db. He can be reached by e-mail or phone at Leo@EisnerSafety.com and 503-244-6151 (Office) and 503-709-8328 (Cell).

The old MDD Harmonized Standards Listing used to be located at the website address of http://bit.ly/MDD_Harmonized_Stds_Listing but as of 2 Feb 2015 the site has been archived.  The new site can be found by following the instructions on the archived site.  First click on the link in the bright yellow band on the top of the old site titled “Internal Market, Industry, Entrepreneurship and SMEs website“, then on the new page that opens click on the “Single Market and Standards” link, then on the left hand bar select the link titled “European Standards“, then on the next web page select the link on the left hand bar titled “Harmonised Standards“. Then search for the section titled “Healthcare engineering” and select the applicable medical device directive you are looking for:

• Medical devices (MDD)
• Active implantable medical devices (AIMDD)
• In vitro diagnostic medical devices (IVDD)

If you need help with your EU CE for the Mark Medical Device Directive, the Active Implantable Medical Device Directive or the IVD Directive, email Leo Eisner directly at Leo@EisnerSafety.com, or call Leo at +1-(503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants). 

Just released as of June 25, 2014 this NBRG Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012 is finally available.  Be forewarned that the document is not yet adopted by the NBRG, which can only be done at the next Meeting in October 2014.  Hopefully it will be adopted at that meeting.  I will check in with my NBRG Risk Management Working Group contacts to find out if they know more about that issue.

But let’s take this chance to review a little about the document and the history of the EN ISO 14971:2012 Annex Z’s.  Future posts will get into more details. The following 3 paragraphs come straight from the introduction of the document as the Working Group summarizes the situation really well.  I happen to know a couple of these working group members personally and I know they have a very good handle on the situation and they have provided some very good background.  

In October 2010, the regular review of ISO 14971:2007 which is the basis of EN ISO 14971:2009 was closed by a broad majority of votes confirming the existing status and the wide-spread acceptance of this standard in the medical devices community, including competent authorities. In November 2010, the European Commission raised a formal objection against the use of several harmonized standards, including EN ISO 14971, followed by an in-depth assessment of the coverage of the Essential Requirements of the Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) by these standards.

As a result of these objections, the Annexes Z to EN ISO 14971 were modified, resulting in EN ISO 14971:2012. This amendment of the EN ISO 14971 standard did not modify the normative parts of ISO 14971:20071. The Annexes Z describe the extent of presumption of conformity that can be based on application of the normative requirements of ISO 14971 alone. The “content deviations”, expressed in the revised Annexes Z, between ISO 14971:2007 and the Medical Device Directives have been commented by many experts in the field of risk management and resulted in diverging interpretations from different stakeholders (e.g. manufacturers, notified bodies, competent authorities).

This document has been prepared as a Notified Body Consensus Paper by a working group headed by the NBRG Vice Chair, with representatives from several European Notified Bodies and industry associations COCIR, Eucomed, EDMA and ZVEI. The paper aims to provide a practical interpretation of these “content deviations” to the Medical Device Directives and give guidance as to how to implement the risk management requirements. The work consolidates prior publications of various sources and is intended to facilitate common understanding between industry and Notified Bodies.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”

• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation 

• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012

This post is on the Eucomed Press Release is Pleased with the EU Commissions’s work on the Joint Plan for Immediate Actions for Medical Devices.

On 18 June 2014 Eucomed released a Press Release about a document the EU Commission released on 17 June 2014.  The title of the document is “COMMISSION STAFF WORKING DOCUMENT Implementation of the Joint Plan for Immediate Actions under the existing Medical Devices legislation”.  Eucomed seems to be pleased with the EU Commission on the approach they are taking in this Joint Plan document.  In the press release Eucomed says: “The Commission’s assessment confirms that much needed improvements to Europe’s notified body system have been successfully implemented and are already yielding tangible results.  The Commission also outlines a series of remaining gaps in the system that it believes can only be appropriately addressed in the new Regulation.” The document comes from the Secretary-General of the European Commission and is addressed to the EU Council (Mr Uwe CORSEPIUS, Secretary-General of the Council of the European Union).

The Commission Staff Working Document provides some background about the history of why this occurred (the Joint Plan) and as Eucomed stated this document “outlines system improvements achieved thus far and highlights remaining gaps to be addressed in new Regulation”. The Commission Staff Working Document says: “As an immediate response to the PIP” (Poly Implant Prothèse Company) “crisis” (fraudulently made breast implants)”, the Commission, in February 2012, took the initiative of agreeing with the Member States a Joint Plan for Immediate Actions aimed at tightening controls and at restoring patient confidence in the regulatory system on the basis of existing legislation, pending the adoption by the co-legislator of the new legislation and its subsequent entry into application. 

Two years after the launch of the Joint Plan, this Commission Staff Working Document communicates the achievements of the plan. It also proposes some aspects that should be continued and intensified.” 

The press release from  Eucomed some very positive comments such as: “The conclusions outlined in the….document reflect the collective feedback from Eucomed member companies that Europe’s notified body system is now subject to tightened controls with tangible results such as unannounced audits of manufacturers and notified bodies.” :”Eucomed…welcomes the Commussion’s concrete progress…”

Serge Bernasconi, Eucomed CEO said “The Action Plan very much reflects our recommendation to implement a ‘reinforced control procedure’ rather than turning the system on its head with a complex, costly and overly bureaucratic measure like the ‘scrutiny procedure’ contained in the Commission’s initial proposal and the European Parliament’s first reading agreement.”

In conclusion of the press release Eucomned goes on to say: “Eucomed also welcomes the Commission’s clear delineation in the final pages of their report of the issues that are critical to a strengthened system and must be addressed in the new Regulation, including the obligations of notified bodies, clinical evaluation and vigilance. The European medical device industry also welcomes the Commission’s reference to registries and looks forward to further dialogue on the topic. …Mr Bernasconi said, ‘…perhaps more importantly, in this document they have made clear where there is more work to be done. I am hopeful that the Commission’s emphasis on these points will serve as inspiration to the Council as it continues negotiations towards its position.'”

Below is the conclusion section of the Commission’s Staff Working Document which is what Eucomed was praising in the conclusion of their press release.

Substantial progress has until now been made in the implementation of the plan. In particular the following achievements can be noted:

• Member States have re-assessed the qualifications of the notified bodies in charge of assessing high-risk devices, thus the vast majority of notified bodies. Member States have, in many cases, modified the scope of the activities of the notified bodies;
• A majority of Member States have requested their notified bodies to carry out unannounced audits and have asked notified bodies to ensure they are informed about incident reports. Notified bodies have reported that they are in the process of launching the unannounced audits; 
• Joint audits of notified bodies by teams involving auditors from several Member States and the Commission (FVO) have until May 2014 been carried out in 22 out of 23 countries having notified bodies and is scheduled for the remaining. The voluntary joint audits have been judged as very useful by all parties involved; 
• Two Commission measures, respectively to ensure a consistent application of the criteria to be met for the designation of notified bodies and on the items to be verified by the notified bodies during an audit were adopted in September 2013. The first of the two measures has made the joint audits mandatory for new designations and re-designations of notified bodies. Five such audits have been carried out until April 2014. About 20 mandatory joint audits are foreseen for 2014; 
• Most Member States have reported on their market surveillance activities. This information is used as a base for assessing the need for further improvement; 
• Monthly vigilance teleconferences with Member States, chaired by the Commission services, have been launched and become regular. The teleconferences have proved to be a very efficient means of ensuring/improving coordination between Member States; 
• The Commission Joint Research Centre (JRC) has started a metadata analysis in the field of vigilance reporting and is conducting a screening of publicly available sources with regard to the safety of medical devices relevant for the European Market;
• A Commission Recommendation on the use of a specific system for traceability of medical devices (UDI) was adopted in April 2013; 
• Dialogues with Member States are on-going on product registers; 
• With regard to incident reporting from medical practitioners and patients, Member States however prefer to develop systems at national level.

The positive progress in the implementation of the plan has been discussed between Health Ministers in several EPSCO Councils.

Many Member States and stakeholders have underlined the importance to continue and intensify the work on certain aspects of the Joint Plan. The focus should be on problematic issues identified during the implementation of this plan that are not yet resolved, such as:

• Market surveillance

The information received under the Joint Plan and the national market surveillance programmes indicate great divergences between the Member States with regard to resources attributed and how market surveillance is carried out. Many Member States recognise that because of a shortage of resources, market surveillance is only reactive and that no proactive surveillance is carried out.

These differences in approaches influence decisions on which products are concretely checked and on which aspects they are checked. Experience has shown that national competent authorities sometimes react in different ways to the same problems. A consequence is that whilst in some Member States the placing on the market or putting into service of a given device is banned or restricted, it may freely circulate in other Member States.

Some of the 20 actions for safer and compliant products for Europe outlined in a Commission communication of last year can be a source of inspiration for the concrete actions to be undertaken, in order to address those issues and to develop best practices (for example, a best practice would be to develop a common understanding of market surveillance and better co-ordination and communication on surveillance data, as set out in paragraph 3 of that Communication).

On the international level, the activities carried out within IMDRF could contribute to an increased coordination.

• Functioning of notified bodies

•  Communication and transparency

The next steps on UDI and reporting of incidents from healthcare professionals are foreseen to be taken following the adaption of the new legislation.

The work on making best use of registers for providing data and identifying problems with devices that has been launched under the Joint Plan should be pursued under the current PARENT Joint Action and in follow up actions envisaged.

The proposals of the JRC project on identifying and developing recommendations for mechanisms to detect signals, trends and increased incident frequency more effectively should allow reducing the number of problems at the source and thus more effectively allocate the scarce resources attributed to market surveillance and vigilance. The results, that should become available mid-2014, should allow for discussions with Member States and stakeholders on the improvements in this respect.

•  Sharing of knowledge and good practices

This post discusses that EN60601-1:2006+Amendment 1 (A1):2013 has finally been Harmonized under the MDD.

This is really big news that many of us in the medical industry have been waiting to hear occur for quite awhile.

What’s The Big News About?

On 16 May 2014 the Official Journal of the European Union (OJEU) published an updated Harmonized Standards List for the MDD 93/42/EEC (2014/C 149/02), therefore making it a Harmonized Standard under the MDD.  Of the five changes to the list for “first publication” documents the one of concern for this post is EN 60601-1:2006 + A1:2013 (it is also known as Edition 3.1 which means 3rd edition of EN 60601-1 [published 2006] + Amendment 1 (or A1) [published 2013]).  The cessation of presumption of conformity for the EN 60601-1:2006 (3rd edition without A1) has been set to be 31 December 2017 ( a 3 year transition period) but there is more to the picture so please read on otherwise you will run into a problem before that date.

Remember That Harmonized Standards Are Voluntary:

NOTE: A reminder that EU Harmonized Standards are not mandatory to meet the Essential Requirements of the MDD but do help make it easier to meet the Directive than going it without the use of Harmonized Standards typically but it is your choice how to approach this issue. I do recommend, to my clients, that they use Harmonized Standards, when they can, since they are common standards that Notified Bodies and Test Houses understand and are familiar with.  So, it is easier to use a Harmonized Standard like EN 60601-1 than to prove, with a higher burden of proof, using a different standard(s) or internal specification(s), etc. that the Notified Bodies may not be as familiar with and then the manufacturer has a higher bar to prove to the Notified Body to prove they meet the Essential Requirements of the MDD.

What’s That Note All About?

In the recently released OJEU Harmonized Standards Listing for EN60601-1:2006+A1:2013 there is an extensive note that discusses the dates of cessation which reads verbatim:

“Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31.12.2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31.12.2015. As from 1.1.2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.”

What’s The Bottom Line?

So, what does the above text really mean?  You will need to consider the A1 Annex ZZ before the end of the transition period for the standard EN60601-1:2006 (3rd edition).  The EN60601-1:2006 transition period ends on 31 December 2017 but on 1 January 2016 you will need to comply, if using this voluntary standard, with the clauses of Annex ZZ of EN60601-1:2006+A1:2013 to be provided with the presumption of conformity that is needed to help meet the essential requirements of the EU Directive in relation to the EN60601-1 standard.  

To learn more about the Annex ZZ refer to the 2nd post in the below listing of past posts on the 60601-1 standard.

How Many Changes Are There in A1:2013 of EN 60601-1:2006 + A1:2013?

There are quite a few changes in A1 as there are 496 changes that were brought into the standard.  Why so many changes?  The original 3rd edition of the standard was released before it may have been totally ready but after about 10 years of development the standard committee decided they needed to get something out before the project would have been sent back to the drawing board (meaning it could have taken another couple years to release it) by IEC rules and also because at that point there was so much anticipation of the release by industry and the Test Houses the standard committee decided it was mature enough to get it out the door.  Of the 496 changes only about 70 of the changes are moderate to significant impact and the rest are editorial and minor corrections including typo corrections too.

For easy reference we have listed below some of our past posts on 60601-1 and 3rd edition + A1 which may be of interest to you.

1. Q&A on OSHA NRTL for AAMI ES 60601-1 3rd ed. + A1
2. Status Update on EN 60601-1:06 + A1:13 for EU MDD & Annexes ZA & ZZ
3. FDA Extends AAMI ES 60601-1 Transition Date to 31 Dec ’13 & Other Important Changes – Recognition Lists 031/032
4. IEC TR 62348:2012 Added in Assessment of impact of most significant changes of IEC 60601-1:2005 Amendment 1 (This Technical Report  talks about the significant and moderate changes to the standard of the 496 changes that were made to the standard.) 
5. When will IEC 60601-1:05+A1:12 turn into EN Standard?
6. IEC 60601-1:2012 Consolidated 3.1 Edition Just Published
7. Amendment 1 of IEC 60601-1:05 (3rd edition) has been published by IEC

This post is a status update on the NBRG RMWG Risk Management Consensus Document

30 April 2014 – The NBRG (Notified Body Recommendation Group) Risk Management Working Group (RMWG) membership will have a face to face meeting in mid May to refine the draft Consensus document on EN ISO 14971:2012.  This meeting has come about because the NBRG RMWG received some feedback recently from the EU Commission and they will consider it and roll it into this document.

The consensus document’s purpose is to reduce the confusion around the EU Harmonized Standard EN ISO 14971:2012 Annexes ZA, ZB, & ZC that amends the EN ISO 14971:2009 version of the standard to align with the 3 Medical Devices Directives (the Medical Device, Active Implantable Medical Device, and In Vitro Diagnostic Medical Devices Directives). The previous plan was to have this Consensus document completed and released by Mid to Late April ’14 but at this point it is hoped the NBRG RMWG will have a final released document by the end of June 2014. We look forward to sending good news about the progress of this document over the next month or so.

If you would like further info on the consensus document and some history please check out the previous posts below (Latest to Oldest):

• MD&DI Article “Collaboration Holds the Key to Clarity on EN ISO 14971:2012”
• NBRG Consensus Document on EN ISO 14971:2012 Is On Its Way MD&M West ’14 Presentation
• NBRG Call for Industry Participation – Survey Understanding Annex Z EN ISO 14971:2012