Managing Regulatory Intelligence for Medical Devices

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| 29 January 2019 | By Richard Vincins  | ©

This article discusses how medical device guidance documents, regulations, standards and requirements are presented in increasing amounts and how regulatory professionals can access, assess, manage and ultimately report to their organizations on the potential impact of regulatory changes. The author covers where and how to access documents and methods for keeping up with regulatory changes using searchable databases, such as provided by FDA, as well as how to find information where such databases are not provided. The article includes “tips” for making the hard work of international regulatory intelligence for medical devices easier and more efficient, such as through subscribing to email feeds, attending conferences and “networking.”
 
Introduction
 
From an industry perspective, due to complexity of different devices, the medical device industry is one of the world’s most regulated and one of the most challenging in terms of regulatory requirements and compliance. For the quality and/or regulatory professional responsible for Class I, low-risk and non-sterile devices, Regulatory Intelligence (RI) may be straightforward. However, for the RI professional working with a Class III, high-risk, implant, electronic-based, sterile and attached to a software application (App), RI may often keep one awake at night. This reality is compounded by several factors requiring constant and careful management by medical device RI professionals. The first difficulty factor is to do more with less; the luxury of having staff of 20 people no longer exists and the RI professional may have to manage multiple work activities alone. The second factor has to do with the new, fast-paced, socially connected, “Internet of Everything Age,” where the proliferation of information is difficult to manage and continuously increasing, seeming exponentially and every day. These factors make the medical device industry challenging not only from a regulatory perspective, but also just keeping up with the large amounts of information presented each day.
 
Several previous articles published on regulatory intelligence provide helpful information for managing regulatory intelligence.1-3 This article discusses how to keep up-to-date with regulatory intelligence primarily with US Food and Drug Administration (FDA), the European Union (EU) requirements and touches on ideas for other countries. This effort is compounded by there being (at last count) more than 30 countries each with some type of regulation for medical devices. Countries regulating medical devices for many years, such as FDA, Health Canada and the European Union, have well-established regulatory frameworks. They utilize their regulatory framework to continually release guidance, position papers and other industry notifications that can be challenging for an individual to keep up-to-date. This means that regulatory expectations are increasing, requiring continuous review, updates, adjustment and assessment on how new developments impacts each organization. Keeping up with these guidances, regulations, standards and other regulatory requirements can be a full-time function quality and regulatory professionals must find a way to “fit” into their already busy schedules.
 
In addition to local regulatory requirements for medical devices, there are a multitude of national and international standards published for wide-ranging application of quality management systems, regulatory requirements or product specific requirements. For example, ISO 13485 published by the International Standards Organization (ISO) as a management system standard has been around for more than two decades.4 ISO 14971 describes the fundamentals for implementing a risk management system and processes within the medical device industry. Many of these international standards have been recognized by regulatory authorities around the world to the point that expectation for compliance, even as a “voluntary” standard, is expected.5 Many national and international standards are beneficial in the medical device industry because they create a harmonized platform both regulators and industry can follow. For example, ISO 13485 was revised in 2016 to create more harmonized quality management system requirements rather than have 30 different quality system requirements around the world. Without these standards, because of the regulatory variations between each agency, the medical device industry would have a more difficult job in terms of compliance. Fortunately, national and international standards provide consistent ways to administer regulations, although they also create yet another level of regulatory intelligence to maintain.
 
US FDA
 
FDA was originally created to regulate drugs that may or may not be effective in treating ailments. Fast forward just over a hundred years since its creation, FDA is one of the strongest, well-funded and regulated administrations in the US or elsewhere. FDA is responsible for drugs, medical devices, food, cosmetics, blood and blood products and tobacco, along with many of the derivations of those. In the last 10 to 15 years, FDA also has implemented a number of regulations for medical devices, including one of the major and most recent ones, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).6 This act helped allow FDA to become almost self-funded to provide it with resources for regulating one of the world’s largest medical device markets. From time-to-time, FDA publishes guidance documents and now has funding for reviewing medical devices, but this function also created a need for the proliferation of ever more information.
Fortunately, today, the Internet can be used to access information. FDA has established a process for releasing guidance documents outlining the agency’s current thinking and, more importantly, their expectations for regulating medical devices. Even with the Internet, finding this information is challenging on the best of days.
 
A few years ago, FDA consolidated their guidance documents into a centralized database, greatly assisting in locating draft and final guidance. Figure 1 shows FDA’s guidance database with links provided in the sidebar allows different search categories along with search criteria in a dynamic results page. This site is a “main-stay” website that should be bookmarked as a central location finding FDA information.
 
Figure 1. Searching Guidance Documents

Vincins-Fig-1-(2).png
 
FDA also has an invaluable resource for identifying national and international standards they have recognized for quality system processes, product performance and product testing requirements. The website for recognized consensus standards, with link shown in the sidebar, also has a good search interface that can be used, including title, standard number, product code, etc., as seen in Figure 2. This information is important during any type of premarket submission to FDA, as expectations are that recognized consensus standards are utilized as part of product performance testing for safety and/or efficacy. As an example, almost all electronic or electrical medical devices must comply with the American National Standards Institute (ANSI) and Association for the Advancement of Medical Instrumentation (AAMI) ANSI/AAMI ES 60601-1, which is a recognized consensus standard by FDA.
 
Figure 2. Search Database

Vincins-Fig-2-(1).png
 

With hundreds of pages of information on FDA’s website, how does one stay up-to-date? One way is by subscribing to a daily email list serve through which FDA sends notification of advisory meetings, newly published guidance, finalized guidance, webinars, premarket approvals, safety notices and myriad of other information. Do this by either bookmarking the “CDRH News and Updates” page using the link shown in Table A or subscribing to email updates via the link shown in the sidebar. When subscribing, one may select a variety of areas, ranging across many branches of FDA, including CDRH specific information. This information should help in keeping up with large amount of regulatory intelligence FDA generates daily. While this is helpful, please note that you will be receiving emails at least daily and some do not like continuous emails cluttering their inbox. The option to visit the news page may be useful.
 
Table A. Available FDA Weblinks
FDA Guidance Document Search Database
FDA Recognized Consensus Search Database
FDA CDRH News and Updates
FDA Subscription Management Center
 
European Union/European Commission
 
The European Union recently published two new medical device regulations with a proliferation of new guidance documents with which quality and regulatory professionals must keep up-to-date.7-9 There are challenges on the European Union side for regulatory intelligence as their website is not easily navigable and information in the regulatory intelligence stream is not always transparent. Under the current Medical Device Directive (MDD) 93/42/EEC, there are a few guidance documents published under the “MEDDEV” designation with links shown in Table B. Several other informative documents and statements by the European Commission are also provided (Figure 3). With publication of the new regulations, Medical Device Regulation EU 2017/745 and In Vitro Diagnostics Medical Device Regulation EU 2017/746, expect many guidance documents to be published and existing guidance updated.
 
Figure 3. EU Guidance Documents
Vincins-Fig-3-(1).png

Like FDA, the European Union has published a listing of harmonized standards for current medical device-related directives, including the MDD 93/42/EEC. Unfortunately, as seen in the link provided in Table B, this list is a scroll-through list, not a searchable database. This structure can make it difficult to locate current information as there is no notification of updates - searching must be done through the local browser search function. In addition, this information is not always updated on a regular basis, so there are out-of-date national and international standards which can cause difficulty during product technical reviews understanding which standards must be applied.
The European Commission also publishes other informative documents that, while not guidance or requirements documents, do contain helpful information. This publicly available information referred to as “DocsRoom,” contains helpful references any quality or regulatory professional responsible for CE Marking will find useful (Table B). This is particularly important with the new regulations published along with a promise for more transparency by European authorities. Maintaining regulatory intelligence in the European Union also requires a larger net of capture information as there is not one centralized location, i.e., Notified Body Operating Group (NBOG) documents, Competent Authority for Medical Devices information and other trade industry groups.
 
Table B. Available EU Weblinks
Guidance MEDDEV
Summary List of Harmonized Standards for the MDD
European Union DocsRoom
 
Other Regulated Country Requirements
 
Outside the US or European Union, the two main markets, regulatory information can be sufficient to sporadic. Other larger medical device markets, such Canada and Australia, have regulatory authority websites dedicated to medical device information, while smaller markets, such as Malaysia or India, medical device information is more likely “buried” in pharmaceutical pages. An article previously published in RAPS Regulatory Focus has detailed links to various regulatory authorities around the world.10 While some may have changed, many are still the main site to visit for further links to specific medical device regulations. Other sources, such as the World Health Organization’s medical device atlas, provide links to regulatory sites.11 Regulatory intelligence also can be challenging in markets where local authorities only have information published in the local language. Japan, China and Brazil also are large medical device markets usually requiring local presence for regulatory intelligence because most information either on the website or publicly available is in the local language. Still, there are a variety of methods for keeping up with regulatory intelligence, including those in more obscure markets that can be significantly challenging.
 
Methods for Regulatory Intelligence
 
The first step in understanding where to get regulatory intelligence is not only knowing when regulatory documents are new or changed, but also knowing how to keep track of these documents. There are a variety of methods, depending on each individual’s organization skills, resources available in the company, and availability of funds.
 
Manual Regulatory Intelligence
 
Developing regulatory intelligence can be daunting at first, but once a system is established it is not difficult to maintain, although it requires time each day or week to visit websites, read through email notifications, check electronic databases and update the information. A simple method for keeping track of documents is to create an Excel sheet with identification number, title, version, publication date, effective/transition date and impact assessment (other variations can be used). It is often helpful to keep track of archived regulatory documents, although usually this is not required. Below is a list of methods for manually keeping up-to-date on regulatory intelligence.
 
  • Enter your email address in websites, list servers or email distribution with regulatory authorities for published information; many major regulatory agencies have some type of email notification system, i.e., FDA, Health Canada.
  • Join mailing lists of consulting firms or other regulatory support groups, i.e., AdvaMed, that often give free webinars, white papers or other information about new and changing regulations/standards. The difficulty with this approach is in receiving even more emails based on marketing their products and services.
  • Become part of a professional organization such as Regulatory Affairs Professionals Society (RAPS) or American Society for Quality (ASQ). These groups also provide learning sources, free educational webinars, forums and networking groups.
  • There are other professional organizations and private companies such as Association for the Advancement of Medical Instrumentation (AAMI), Medtech Europe or Notified Bodies that once a member or customer usually have educational information on a regular basis.
  • Network with friends and colleagues. When attending conferences, such as RAPS Convergence or other industry conferences, use the opportunity to get to know new people.
  • Establish “regulatory intelligence time” in your schedule, perhaps an hour on Friday morning or afternoon devoted solely to gathering information from these sources.
 
Depending on the number of markets to which the organization distributes, manual methods may be appropriate; if part of a large organization or distributing in more than 10 countries, manual methods can prove difficult to manage.
 
Electronic Automated Regulatory Intelligence
 
In years past, there was little option beyond manually finding information. This entailed visiting the local library to search through articles or going to industry meetings. This has changed dramatically with the availability of information via accessible databases and cloud-based applications. However, depending on the service provided, these resources usually involve a subscription or a flat fee.
 
  • A few organizations provide purchase of standards that sometimes - for a small additional fee - will notify you when the standard is updated. This usually applies only to standards such as ISO or IEC documents.
  • Services providing access to standards usually do not cover guidance documents or other regulatory documents, leaving a gap in regulatory intelligence. There are an increasing number of providers bridging this gap by providing notification on other regulatory documents.
  • As part of the service package, subscription-based service can not only provide notification of standards and guidance documents, but also electronic copies.
  • Often these services have a cloud-based system, so this regulatory intelligence is kept in one location able to be accessed via the Internet. This is helpful for keeping all related standards, guidance documents, registrations, etc., in one central location.
  • Electronic automated services are exceptional at filtering through identified regulatory markets by providing notification of standards, guidance documents, new regulations and other information. But this service comes at a price. It also should be noted that many companies, depending on their needs and depending on the markets they distribute product, use a mixture of both manual and automated methods.
 
Conclusion
 
During a training session or when going through a long list of standards from memory, the question ‘How do you keep track of everything, read everything and know how to get regulatory intelligence?’ is often raised. The answer is fairly simple. Before you go to bed at night, close your laptop, put it under your pillow and hopefully, by osmosis, information gets into your memory cells! The real answer is, unfortunately, not so simple. We all know too well the challenges inherent in keeping track of so much regulatory information today, and it is not going to get any easier. Fifteen to twenty years ago, there were perhaps a half dozen, well-documented regulatory markets. Today, there are at least triple that number and the number will continue to increase. The citations, links and information provided in this article have been located, found and reviewed being on mailing lists, involved in RAPS forums, and being part of other regulatory forums. Using a method of osmosis for some people may work, though most will find that they need to establish methods that are manageable and appropriate for their organization.
 
Keeping up with new and revised regulatory requirements is the first step and probably the most challenging. With an understanding this is not a static process and depending on the organization, there are different methods that can be applied for regulatory intelligence. As regulatory requirements continue to increase, so will the bulk and speed of accompanying information increase. Once becoming aware of new and revised regulatory requirements, one must assess them for their potential to impact the quality system or product compliance. Because of continuing regulatory changes for the medical device industry, it is important for each organization to establish defined methods for gathering, reviewing, updating, and maintaining regulatory intelligence.
 
References
 
  1. Brown-Tuttle, M. "Regulatory Intelligence Tools Compendium." Regulatory Focus. February 2017. Regulatory Affairs Professionals Society.
  2. Slabiak T and Brown-Tuttle M. "Regulatory Information and Intelligence Tools: Devices." Regulatory Focus. April 2012. Regulatory Affairs Professionals Society.
  3. Brown-Tuttle M. "Regulatory Intelligence 101." Regulatory Focus. December 2004. Regulatory Affairs Professionals Society
  4. International Organization for Standardization (ISO) website. Accessed 23 January 2019.
  5. OECD/ISO (2016), “International Regulatory Co-Operation and International Organisations: The Case of the International Organization for Standardization (ISO),” OECD and ISO.
  6. Background on MDUFMA. FDA website. https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm109149.htm. Accessed 23 January 2019.
  7. Brooks P. “Six Things You Need to Do to Prepare for the New EU Medical Devices Regulation.” Regulatory Focus. Posted 15 June 2017. Regulatory Affairs Professionals Society. Accessed 23 January 2019.
  8. Richard K. "Complying with the New IVDR Regulations." Regulatory Focus. August 2018. Regulatory Affairs Professionals Society.
  9. Fillmore R. "Implementing the New EU Medical Devices Regulations." Regulatory Focus. November 2017. Regulatory Affairs Professionals Society.
  10. Op cit 2.
  11. Global Atlas of Medical Devices. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO.
 
About the Author
 
Richard A. Vincins, RAC is part of Oriel STAT A MATRIX team as vice president global regulatory affairs responsible for regulatory affairs and quality activities. In this role, he is responsible for regulatory strategies, regulatory submissions, remediation of technical documentation, conducting quality system audits and providing regulatory expertise in national and international regulations. He brings more than 25 years of experience in the medical industry, including worldwide regulatory compliance efforts for medical device, IVD and pharmaceutical companies. Vincins is a Chartered Quality Professional, ASQ Certified Biomedical Auditor and Certified Quality Auditor. He holds the RAPS RAC (US) and RAC (EU).He can be contacted at rvincins@orielstat.com.
 
Cite as: Vincins R. “Managing Regulatory Intelligence for Medical Devices,” Regulatory Focus. January 2019. Regulatory Affairs Professionals Society.

 

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