Enjoy our Second global standards & regulatory update. It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry
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.?
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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 .
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)
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
Keeping Seniors in Their Homes with Technology
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).
A single report was $3,500 (US$) per report or for both of them was $6,500 (US$) and NOW new customers can get them for only $2,500 (US$) for a single report and both reports for $4,500 (US$). This is a steal compared to the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov 2015 in Japan (Kobe & Tokyo), and also the money saved not having to be on the committees, the travel expenses for getting to the meetings, the time in the meetings, and the expected contribution to the standards development for being in these committees. That is a lot of man hours that you get inexpensively from my hard work.
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.
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