World-Wide Medical Device Regulatory & Standards Updates
Special global update post that gives you tools to help strategically plan for regulatory, & standards updates for the Medical Device Industry
For this special posting I thought we should travel the world & provide you with a great deal of valuable information to help you on your product development way, including regulatory support, standards support, and more
We have broken this post into national areas and some of the National listings have sub-listings if more than one Agency or State is involved.
- USA FDA FCC
- EU UK (MHRA)
- Australia (TGA)
- China (CFDA)
- Russia and Eurasian Union
- Standards Updates
- ISO 13485:2016 – Medical Devices. Quality Management Systems. Requirements for Regulatory Purposes
- ISO 14644-1:2015 & 14644-2:2015 – Cleanrooms and associated controlled environments – Parts 1 & 2 – Updated Dec 2015
- IEC/PAS 63023:2016 – Medical electrical system – Input interface for haemodialysis equipment for use of external alarming device
- 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 – 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? It is likely you will need to redesign your products to meet this standard which many regulators expect you to meet.
- Standards Reconnaissance Database – this service helps you maintain your list of standards, be up to date on current and new /developing standards. Also, get strategic information about the future of these current, new and developing standards. Save time and money using this service that would take you many more hours than the cost of this service to keep up to date on these standards.
FDA – There is a lot happening at the FDA that you need to be aware of so you can strategically plan for this year and the future
Part of our Standards Reconnaissance Database Service is that we are building a listing of current FDA CDRH Guidances Final & Draft plus we are 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.
1) FDA has published a report of their strategic priorities for the two year period of 2016 – 2017. Review the report.
2) The above report also reflects back on some of the major improvements and priorities the FDA focused on over the 2014 – 2015 time period. You can review the previous strategic priorities report.
3) CDRH Fiscal Year 2016 Proposed Guidance Development and Focused Retrospective Review of Final Guidance – This webpage includes 3 lists. List “A” & “B” priorities for this FY 2016. “A” list being the higher priority Final & Draft Guidances “the Agency fully intends to publish”. The “B” list “the Agency intends to publish as resources permit”. The last list is part of a multi year project for a full retrospective review of Final Guidances that FDA is reviewing to determine if they should be revised or withdrawn. This years list of past Final Guidance being reviewed include the years 2006, 1996, 1986, or 1976.
The history for the retrospective review is that “on June 5, 2014, CDRH held a public workshop to provide stakeholders an opportunity to actively engage with Center representatives about the guidance development process, provide transparency into guidance priority development, promote dialogue on guidance process improvements, and generate ideas for assessing the impact of guidance (Public Workshop – Center for Devices and Radiological Health Guidance Development and Prioritization Public Workshop, June 5, 2014). One question that was raised was how current previously issued final guidances remain.” For this year the “CDRH would appreciate external feedback on” the final guidances that were “issued in 2006, 1996, 1986, or 1976” if they “should be revised or withdrawn. CDRH intends to provide such lists annually through fiscal year 2025 so that by 2025, FDA and stakeholders will have assessed the applicability of all guidances older than 10 years.
4) FDA has issued on the last day of 2015 (Dec 31, 2015) a very contentious Draft Guidance on “Emerging Signals” (Postmarket Medical Device Signals). It is designed to catch signals of medical device safety issues earlier to prevent adverse events. This Guidance outlines how the FDA will track and release such information publicly. RAPS has posted a well written article explaining the guidance and also showing the reactions on both sides of the issue.
5) Draft Guidance – Postmarket Management of Cybersecurity in Medical Devices, issued Jan 22, 2016 (Was announced by FDA on 15 Jan 2016). The scope of this draft guidance states: “This guidance applies to: 1) medical devices that contain software (including firmware) or programmable logic, and 2) software that is a medical device. This guidance supplements the information addressed in the FDA guidance document titled “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software.” This guidance does not apply to experimental or investigational medical devices.”
6) Two Day FDA Workshop (just finished this afternoon), Moving Forward: Collaborative Approaches to Medical Device Cybersecurity, Jan 20 – 21, 2016, at the FDA White Oak campus just finished process (you can see the archived webcast). A program book goes with the Workshop. There are a lot of different articles about this workshop and the Draft Guidance (above item) at RF TODAY, Fierce Medical Devices, SoftwareCPR (1/19/2016 post)
7) CDRH Industry Basics Workshop – Unique Device Identification (UDI), webcast, on January 27, 2016. View the webcast (when live). You will be able to view the webcast after it originally airs on the FDA website shortly after the webcast in the CDRH Learn section of the site. Also, there are several new modules added to the CDRH Learn webpage (A great place to learn more about FDA issues using presentations and webinars) including the topics of post-market activities, Purchasing Controls and Process Validation, CAPA, Gowns – Regulatory Responsibilities.
8) Draft Guidance, Unique Device Identification: Convenience Kits, issued Jan 4, 2016, This draft Guidance document is a change in FDAs policy about “convenience kits” in relation to the UDI (Refer to the 2nd paragraph of the Introduction of this document).
9) One Day FDA Workshop, Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids, Apr 21, 2016, at the FDA White Oak campus, sign-up for the Workshop on the Workshop page or the webcast link will be available on Workshop page after April 13, 2016.
1) The FCC has redesigned their website to be more useable and more functional to improve the navigability and searchability of the site. The change-over occurred on Dec 10, 2015. FCC had written a pretty extensive post on the issue and they are asking for your feedback on how it works for you.
2) FCC has expanded their Hearing Aid Compatibility requirements to “keep pace with development in technology and the wireless market” and to ensure that “emerging voice technologies are subject to our hearing aid compatibility requirements, without regard to outdated scope restrictions or regulatory service classifications.” You can view the text of the Commission’s Fourth Report and Order expanding the scope of its hearing aid compatibility (HAC) requirements.
Where does the Draft EU Medical Device and the In-Vitro Diagnostic Regulations stand?
There is a lot being said about both draft Regulations and my three 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 recently 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). Let’s see what is up on Erik’s & MedTech Europe’s sites of late:
1) On Erik’s site he has done a post titled “End of year bonanza” and it focuses on looking back at what happened and some of what is to come in 2016. It is well worth a read as Erik brings some really good insight into the subject.
2) MedTech Europe wrote about Advocacy activities related to the MD & IVD Regulations. It also looks at the past and future work to be done.
MHRA – (The Medicines and Healthcare Products Regulatory Agency)
a) If you need to pay MHRA for your product or application please make note that their bank details have changed. Their notice was posted on 4 Jan 2016. The post deals with “How to make a payment to MHRA by credit or debit card or a bank transfer and manage your account on iRIS.”
b) MHRA begins to develop human factors guidance with stakeholders.
c) Agency Highlights post looks back at what the Agency has achieved in 2015.
TGA – (Therapeutic Goods Administration)
1) New Tyvek® materials: regulatory obligations – DuPont has announced an upgraded manufacturing process for Tyvek® 1073B & 1059B now using flash spinning technology. TGA is concerned as this change will impact a large number of medical devices that are included in the Australian Register of Therapeutic Goods Listing. TGA indicates that “In order to meet the conditions of inclusion on the ARTG, manufacturers transitioning from the existing Tyvek® 1073B or 1059B to the new Tyvek® 1073B or 1059B need to check that the performance and safety of their medical devices continue to meet the Australian Essential Principles (EPs).”
2) The TGA issues a bulletin for Medical Device Safety Updates and one of the subjects in this Vol 4, No. 1 (Jan 2016) is on “Battery management a growing issue”. The bottom line is that TGA suggests that health organizations should ensure that suitable protocols and procedures are developed to optimize battery management and reduce risks. TGA indicated in this article that over 50 related deaths or serious injuries over a 10 year period were either caused by or related to batteries of medical devices.
CFDA – (China Food & Drug Administration)
Did you know you can find Guidances for CFDA on their website? It takes some effort and mostly in Chinese. You can always get them translated. These guides are like the Guidances for other medical device regulators. Just like most other regulators these guides are recommended and not law so they can’t be enforced but it benefits you to use the standardized approach discussed in the Guides as the CFDA is used to what is described in the Guide so you tend to have a smoother submission that way. Two of importance that were issued in 2015 are the Medical Device Software Registration Technical Review guidelines (In Chinese) which was issued on August 5, 2015.This one guides manufacturers on application documents of medical device software registration and standardizing the technical review requirements for medical device software. The second one is a Technical Guideline for Clinical Evaluation of Medical Devices (In Chinese). It is applicable to the clinical evaluation of Class II and Class III medical device registration application, and not applicable to the clinical evaluation of in vitro diagnostic reagents regulated as medical devices.
Alexey Stepanov has one of the very few sites that regularly updates you on what is going on in Russia & The Eurasian Union for medical device requirements and regulations. He is considered an expert in the subject and has presented his material thru LNE-Gmed, a European Notified Body.
For the end of 2015 he wrote a post titled “Five Things You Should Know about Medical Device regulation in Russia, CIS and the Eurasian Union in 2015”. He discusses the Eurasian Medical Device Regulations, Some Progress in Russian Medical Device Registration, Russia tightening controls on Medical Devices, an Overhaul of the Medical Device Approval Process in the Ukraine, and Medical Device Additional Tax Problems solved in Russia.
ISO 13485:2016 – Medical devices. Quality management systems. Requirements for regulatory purposes
The draft standard is in the process of being published and is under the Final Draft International Standard (FDIS) stage. From my review of the ISO project schedule for the standard it looks like the standard will finally be published by Mid February 2016 so within the next couple weeks or so.
The white paper that the Working Group WG1 of the Technical Committee TC210 is proposing that there be a three (3) year transition period.
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.
Find out more about this standard on Feb 9, 2016 @ 1PM EST. 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 be running a free Webinar titled “Understanding the Changes to ISO 13485:2016”. It is being presented by Mark Swanson who is a member of the ISO 13485 working group. Sign-up now.
An insider tip, please joint he webinar early the day of the webinar because it is first come gets a seat at the live webinar otherwise you will get the recording when ready.
Also, if you want more info on the standard now you can listen to a podcast on the subject too.
ISO 14644-1:2015 & 14644-2:2015 – Cleanrooms and associated controlled environments – Parts 1 & 2 Updated Dec 2015
ISO News article of 21 Jan 2016 on the update of these standards – “Revised cleanroom standards incorporate best practices for contamination control”
IEC/PAS 63023:2016 – Medical electrical system – Input interface for haemodialysis equipment for use of external alarming device
This document is a Publicly Available Specification. This is the first edition of the standard and will be added into our Standards Reconnaissance Database shortly as it is part of the IEC Sub-committee SC62D.
The Introduction to the PAS explains why it was developed. It was developed to help deal with the concern of extracorporeal circuits major issue of blood loss hazard that is brought up in IEC 60601-2-16:2012 Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment sub-clause 126.96.36.199.104.1.
The abstract on the IEC website states: “IEC PAS 63023:2016 establishes a unique input interface for connection of an external alarming device to haemodialysis equipment. The input interface of the haemodialysis equipment is designed as a simple solution, which takes a single fault condition of the input interface into account, to stop the extracorporeal blood flow in case of needles slipping out from the fistula or graft detected by the external alarming device.”
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
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. You will have the option of a general report that is issued based on information I gather and put together for the reports (2 different reports detailed below).
I am heavily involved in the medical device and home use medical device standards development process and involved in many of the committees that this database focuses on. A partial listing of my involvement includes:
* Co-chair of U.S. TAG (technical advisory group) for IEC/SC 62D
* Convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”
* Member of AAMI Electrical Safety (ES) Committee, which develops the US version of the IEC 60601-1 standard (ANSI/AAMI ES 60601-1)
* Member of US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment).
* Member of TC 62/SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1 to testing of medical electrical equipment, and to deal with general testing requirements not assigned to other maintenance teams.)
* Member of AAMI committee for Home Use Medical Devices
* Member of US TAG for Active Assisted Living SyC (System Committee approach for an aging population, their families and care provides with solutions that enable them to live longer but also to live a better life at home instead in a hospital or nursing home or other clinical setting – this SyC includes the home care medical device industry).
* Member of AAL SyC WG4 focused on Regulatory Affairs at the national and regional levels of regulators on AAL
I went to the annual meetings of both IEC TC62 (& associated Sub-Committees) and the Active Assisted Living System Committee (AAL SyC) held in Japan for two weeks in Nov 2015. These meetings were in Kobe and Tokyo respectively.
The IEC TC62 group covers Electrical Equipment in medical practice (the whole 60601 series of equipment and additionally standards related to electrical equipment in medical practice which is fairly broad including medical networks in hospitals with the IEC 80001 & 80002 series of standards, Usability, and Guidance for Risk Management to name a few areas).
The IEC TC62 general report is only $3,000.00 (US$), which is a bargain compared to paying many times that to have an employee be on one of these committees. The Home Use Medical Equipment and Systems report will discuss areas such as where is the AAL SyC at and what guidances and/or standards are planned, more detail on the focus of the committee and it’s plans. I will also report on the status of the IEC and AAMI HA 60601-1-11 standards. This general report is $3,000.00 (US$), which is a lot less expensive than having one of your employees sit on one of the standards committees.
The package price for both general reports is $5,500.00 (US$).
Please contact me with any question on this service at Leo at EisnerSafety dot com or 503-244-6151
Do you need to keep track of standards for your regulatory and quality system requirements? We can do this for you with our Standards Reconnaissance Database.
The Standards Reconnaissance Service helps medical electrical device manufacturers (our specific focus of our database) keep up to date on new standards, updates to existing standards, and draft standards under development. This assures you can plan ahead of any major changes.
We reduce your burden on this time consuming task, so you can focus on what you are good at – developing products.
We do this at very reasonable rates. We have also broken the service in different tiers to match your needs.
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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