Insights & Intelligence for Regulatory Leaders

This article is an excerpt from the Regulatory strategy as a competitive advantage ebook.

Table of Contents

• The regulatory revenue opportunity
• Regulatory responsibilities
• Limitations of the "cost-center" approach to regulatory affairs
• Regulatory as a revenue function
• Competitive advantage #1: Faster time to market
• Competitive advantage #2: Cost avoidance
• Competitive advantage #3: Out-pacing competitors
• Why invest in regulatory/revenue alignment?
• Getting started - 3 steps to move towards a revenue-aligned RA team

It is well known that medical technology (medtech) companies are highly regulated, given the potential risks their products present. Understanding and complying with the complex regulations in each country is, therefore, a necessary part of marketing and selling medical devices. To realize any revenue from a medical device, it must not only demonstrate compliance with all applicable regulations, it must also receive and maintain market clearance from each country in which it is to be sold. No market clearance means no revenue. Given the key role regulatory compliance plays in revenue attainment, regulatory teams, tools, and processes present a significant opportunity for differentiation for organizations willing to invest in them.

For the majority of medtech companies, however, regulatory departments have traditionally been treated as operational cost centers, with departmental improvements focused on cost reduction and efficiency improvements. Limited investment in people and tools, and limited interest in digital transformation, have left regulatory teams across the medtech industry underfunded and under-resourced.  

This has led to great resourcefulness within the RA community, where most members can point to heroes within their team who worked long hours to meet a submission deadline, headed off a disaster by uncovering a pending expiration, created ad-hoc systems to organize information and streamline communication between the RA and QA teams for smoother audits, or have otherwise gone above and beyond their typical responsibilities.

Regulatory teams, however, have the potential to be a revenue-driving competitive weapon for companies that are willing to look at them a little differently and invest in regulatory performance above regulatory cost-effectiveness. Well-supported regulatory teams can provide a true competitive advantage by providing the resources and direction to:

• Capture market share by being first to market with novel devices.
• Avoid lost revenue by effectively tracking and planning for registration renewals/updates.

• Out-pace competitors and grow market share by adapting to regulatory changes more quickly and taking advantage of competitors’ non-compliance or inability to enter a new market.

We believe we are entering a new era for regulatory affairs within the medtech industry. One in which RA teams have a seat at the table when go-to-market, competitive positioning, and strategic decisions are being made.  

In the medtech industry, regulatory affairs (RA) teams have a broad range of responsibilities across the product lifecycle:

Premarket regulatory strategy

Obtaining market clearance for a new medical device is the primary activity typically attributed to RA teams. It is not unusual for a regulatory team to be given market entrance projects with little warning, but ideally, the RA team would be brought in as early as possible to contribute to go-to-market discussions.

Premarket regulatory strategy, at a minimum, involves:

• Determining the most appropriate pathway to market approval. For example, a 510(k) or PMA submission in the U.S.
• Working with quality, product, and other teams to gather information needed for market submission.
• Establishing communication with applicable regulatory bodies and third-party approved auditors.

• Compiling and submitting required documentation for market approval. This includes managing follow-up activities, questions, and requests for additional information throughout the approval process.

Forward-thinking organizations often look to bring in RA teams even earlier in the process. As regulatory experts, RA professionals can provide unique insight into product development plans. In consultation with R&D teams, can help to refine product strategies, and steer development in areas that will reduce regulatory hurdles when new products are ready to be commercialized.  

Maintaining regulatory compliance for existing products

While the primary focus of regulatory teams is often considered to be new market submissions, the majority of their time is actually spent on maintaining compliance for products that are already in-market. Even in situations where market registrations do not expire, constant vigilance is required to ensure that devices remain compliant with current regulations. These efforts take a considerable time for a typical RA team because information is often spread across disparate systems, where it can be difficult to find and confirm.

Maintaining regulatory compliance for approved devices includes:

• Staying on top of changing standards and making changes as required to existing technical files and other documentation.
• Submitting appropriate documentation updates when there is a change made that could potentially affect the efficacy or safety of the product, such as a material switch or facility change.  
• Understanding pending regulatory changes and proactively addressing any that have an impact on devices currently in-market.
• Tracking registration expirations and preparing for timely re-submissions to ensure there is no lapse in market clearance.

Post-market activity

Post-market surveillance and vigilance activities are required by most countries and should involve the cooperation of the quality and regulatory teams. Ensuring that changing post-market reporting requirements are understood and complied with is an important regulatory responsibility.

Regulatory teams typically play a role in:

• Post-market surveillance of adverse events, complaints, and any issues associated with a device in the field.
• Assembling and submitting any required periodic safety reports to country/regional health authorities.
• Post-market vigilance and reporting of serious events to the appropriate regulatory agencies.
• Any required communication with regulatory authorities regarding adverse events or concerning trends in product quality.

Ask any RA professional, and they are likely to tell you that they work long hours and are often scrambling to meet looming deadlines...

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What are Essential Principles?  

Essential Principles (EPs) are requirements established by a country’s health agency. Medical device manufacturers need to prove that they comply with these requirements in order to sell their device in each country where they are required. This is often tracked in a burdensome table in which each requirement is explained by applicable standards and other items used to demonstrate compliance with each requirement. The manufacturer will link their evidence files to prove that they meet the requirement or provide an explanation as to why it is not applicable in their situation.  

Think of this like cliff-notes for the submission and related documents. Submission documents, their locations, and explanations can all vary depending on the device type, manufacturer, and their processes.  

What countries require Essential Principles?

Not every country requires EPs for their submissions. Some of the main countries that do require them include:

• The European Union – where they are called General Safety and Performance Requirements (GSPR)
• Australia
• Malaysia
• Singapore (accepts EU documentation in most cases)
• China

What do Essential Principles look like?

GSPR (General Safety and Performance Requirements) in the European Union are an example of Essential Principles requirements. The language in the GSPR comes directly from Annex 1 of the EU MDR of 745/2017 for medical devices and EU IVDR 2017/746 for in-vitro diagnostic devices. Medical device manufacturers are taking the text of this regulation, numbering and all, and documenting whether they apply to it, the standards that they apply to, and then providing their evidence.  

Let’s look at an example that directly comes from EU MDR 2017/745, Regulatory text, Annex I, 7th requirement:

“Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.”

The validation of the Essential Principles for this particular requirement would be displayed in a table like the one below. Note that the description column in the table and in the EU MDR regulatory requirement are identical to each other.  

These tables change constantly, and it is a large administrative burden on the regulatory professional to quickly identify changes, perform a gap analysis (check for changes and do testing if needed), and update the tables when required. In addition, we have seen the following issues caused by changing standards:

• Large companies can have hundreds to thousands of Essential Principles tables. Without a bulk upload, this can take an incredibly long time to process all of those documents.  
• Errors can occur with standards updates by missing a product that is associated to a standard.  
• If a gap analysis is done too late and testing a product to a revised or new standard is required - your product might need to be blocked from a market for months, which could mean massive revenue loss.  

• Accidentally missing a reference to new testing data because only the standard was updated.

Rimsys allows regulatory professionals to be notified of standard changes and even do bulk additions and deletions of documents, standards and certificates to your Essential Principles Tables, which can save regulatory professionals countless hours in administrative work. For more information on how one of our customers benefited from our Essential Principles tool, reducing their EP and GSPR maintenance by 99%, read our Bisco case study.

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FDA Standards and Conformity Assessment Program

The FDA Standards and Conformity Assessment Program (S-CAP) seeks to drive the “development, recognition, and appropriate use of voluntary consensus standards for medical devices, radiation-emitting products, and emerging technologies.” Conformity to relevant standards is voluntary, unless a standard is “incorporated by reference” directly into a regulation. However, demonstration of conformity with FDA-recognized standards in a premarket submission is encouraged by the agency and will streamline the review process.

According to the FDA, S-CAP is designed to:

• Produce and implement clear policies to promote the appropriate use of standards in regulatory processes.
• Anticipate the need for and leads the development of national and international consensus standards.
• Advance initiatives to enhance confidence in conformity assessment activities.
• Foster innovation and standardization in technologies that facilitate patient access to novel devices.
• Provide leadership in standards quality and utilization through outreach and global harmonization.

What is a voluntary consensus standard?

The FDA recognizes standards that medical device manufacturers may use to demonstrate that they have met a relevant requirement of the FD&C act. The FDA may recognize all or part of a standard established by an international Standards Development Organization (SDO). Not all standards recognized internationally are recognized by the FDA.

The most common SDO is the International Organization for Standardization (ISO), and some of the most recognized ISO standards for medical devices include:

• ISO 14971- Applications of risk management to medical devices
• ISO 10993 – Biologic evaluation of medical devices
• ISO 11137 – Sterilization of healthcare products

Note that ISO 13485 is not recognized by the FDA for use in standard market submissions, but it is recognized as a quality standard under the MDSAP program.

Some of the other recognized SDOs include:

• ANSI – American National Standards Institute
• ASQ – American Society for Quality
• IEC – International Electrotechnical Commission

In some cases, FDA consensus standards have an identical U.S. adoption, such as IEC 60601-2-47 and ANSI/AAMI/IEC 60601-2-47. For a full list of recognized standards, see the FDA’s Recognized Consensus Standards database (the “Standards Organization” field lists all SDOs).

Using consensus standards in premarket submissions

Demonstrating conformity with FDA-recognized standards can facilitate the premarket review process for:

• 510(k) submissions
• De Novo requests
• Investigational Device Exemption (IDE) applications
• Premarket Approval (PMA) applications
• Product Development Protocols (PDP)
• Humanitarian Device Exemption (HDE) applications
• Investigational New Drug (IND) applications
• Biologics License Application (BLA) for devices that are regulated by CBER as biological products

It is important to recognize that conformance to a recognized standard often satisfies only a portion of the requirements of a premarket submission. When using an FDA-recognized consensus standard, a manufacturer should submit a Declaration of Conformity (DOC) to the standard and list it in the CDRH Premarket Review Submission Cover Sheet (form FDA 3514). Elements of a Declaration of Conformity include:

1. Name and address of the applicant/sponsor responsible for the DOC.

2. Product/device identification, including product codes, device marketing name, model number, and any other unique product identification data specific to the DOC in question.

3. Statement of conformity.

4. A list of standards for which the DOC applies including, for each standard, the options selected, if any.

5. The FDA recognition number for each standard.

6. The date and place of issuance of the DOC.

7. Signature, printed name, and function of the sponsor responsible for the DOC.

8. Any limitation on the validity of the DOC (ex: how long the declaration is valid, what was tested, or concessions made about the testing outcomes).

Supplemental documentation requirements in support of a DOC

Supplemental documentation in support of a DOC is often required. Adherence to a standard may not be sufficient for the FDA to make a regulatory decision. The example used in the FDA’s guidance document, Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices, is that of ISO 14971. ISO 14971, Application of risk management to medical devices, does not list all of the detailed acceptance criteria for necessary performance tests. According to this guidance, the following general principles should be followed when determining the need for supplemental documentation:

• When the consensus standard includes both a test method or test procedure with a single set of predefined acceptance criteria, FDA should generally not request data relating to the specific consensus standard in the DOC.
• When the consensus standard describes a test method or procedure, but does not include acceptance criteria, the submitter should provide an assessment of the results and how conformity was determined.
• When the consensus standard includes choices related to, for example, what is to be tested, which test methods to use, or acceptance criteria to assess conformity, the submitter should include an explanation for the choices and selections made.

Managing standards updates

When a consensus standard is replaced by a newly recognized standard, the older version is withdrawn following a transition period. That transition period is provided to allow submitters time to prepare to use a new version of the standard. During the transition period, the submitter may continue to use the old version of the standard, though a justification for use of the older version should be provided in instances where adherence with a new version would require significant questions to be addressed.

Transition periods will vary based on the scope of the change to the standard and can be found in the standard’s supplemental information sheet (SIS). When a standard changes during an active review of a premarket submission, the FDA will continue to review the submission based on the previous version of the standard.  

Learn more about how Rimsys can help your regulatory team manage standards.

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Regulatory affairs professionals at large medical device companies must manage heavy submission workloads, registrations for products currently on the market, and ever-changing regulatory requirements. Regulatory information management (RIM) systems have been available for some time, but only in the pharmaceutical industry. This means that many regulatory professionals in the medical device industry continue to rely on paper documents, spreadsheets, and other outdated tools and methods to manage their work.  

Medtech RA teams who implement RIM systems built for the pharma industry do not have the functionality they need to manage the complex workflows associated with medical device submissions and registration maintenance. In fact, at Rimsys we have worked with a number of medical device manufacturers who moved away from their RIM pharma system without successfully implementing it.

What is RIM for the pharmaceutical industry?

RIM systems designed for the pharmaceutical industry (Pharma RIM) provide a centralized system for managing the drug approval process. Pharma RIM systems differ in their scope, but often handle processes from pre-registration through post-registration including the creation and management of dossiers for investigational New Drug (IND) and Clinical Trial Application (CTA) submissions.

Pharma RIM systems also provide content/document management capabilities, often tied to Master Data Management (MDM) functionality which provides for the storage, retrieval, and integration of the large amounts of data tracked by pharmaceutical companies. In addition, Pharma RIM systems can assist with electronic submissions of regulatory dossiers.

Why Pharma RIM doesn’t work for medical device manufacturers

On the surface, regulatory solutions for the pharmaceutical and medical device industries appear similar. Both industries are highly regulated, require controlled workflow and document management, and have complex market entrance requirements.

However, the regulatory requirements governing the development and marketing of a drug are very different from that of a medical device in the following areas:

Harmonization of regulatory requirements

Global harmonization of pharmaceutical guidelines, through the International Conference for Harmonisation (ICH), is much more complete than in the medical device industry. Regulatory professionals working in the medical device industry must manage market-specific device classification rules, submission regulations, reporting requirements, and more.  

The harmonized requirements in the pharmaceutical industry mean that, while submissions need to be made to each market, they are largely the same.

Change management requirements

Medical devices typically have multiple versions, iterations, and packaging options that inherently make market submissions and registrations more difficult to manage than in the case of pharmaceuticals. In addition, a medical device may undergo changes as the result of a supplier change, software update, or a corrective action made to the manufacturing process or product (among other possible changes). In most markets, any change that has the potential to affect the safety or efficacy of a device must be reported. However, the reporting requirements, including timing and submission formats, vary with each market. RA professionals must understand and track every requirement in every market.

Updates to pharmaceutical products, such as labeling changes, are less common and the notification process is more streamlined because of globally harmonized processes.

Regulatory pathways and options

For many medical devices, the regulatory pathway is not always clear – leaving RA teams to determine the path most likely to succeed and, in some cases, most advantageous to obtaining clearance in additional markets. For example, a new device in the United States might achieve faster approval through the 510(k) process, but the manufacturer must reference a predicate device already on the market. Whether the FDA accepts the identified device as a predicate and whether a PMA process would provide the company a greater competitive advantage, are strategic questions for the RA team to answer.  

Devices are classified based on different criteria in different countries, making it necessary to analyze the device classification separately for each market as well. If the device is software or a combination device, the approval process may differ from the typical device approval pathway in some countries, but not others. In some cases, multiple options are available, such as participation in the MDSAP program.

Product complexity

From a regulatory data standpoint, medical devices are significantly more complex than drug products. In a pharma RIM system, a new drug is set up in the same manner as existing drugs. For a medical device, there are many more data points that need to be tracked and standards that need to be identified based on such things as whether the device is sold sterile, contains electronic equipment, or includes software.  

A medtech RIM system allows each device to be configured and tracked appropriately for each market.

What are medtech RIM systems?

Holistic RIM systems for medical device manufacturers enable users to create a single source of truth for all data associated with regulatory submissions and registration management. RIM systems are used by regulatory teams to digitize data and automate key processes across the organization.

Medtech RIM system functions are designed to support a range of regulatory activities across a product’s lifecycle. In addition to centralizing core regulatory data and managing regulatory registrations and certificates, RIM systems can also support:

• Submission planning, authoring, and assembly
• Market entrance requirements and pre-built submission templates
• Collaborative content authoring and project management
• UDI management
• Standards management
• Essential principles/GSPR management, including bulk updating

RIM systems are product-centric, structuring data around individual regulated products and their requirements, market by market. This means that RIM systems can track product-specific data and link standards with individual products to easily identify those affected by standards updates.

RIM for regulatory projects and processes

Digitization and automation of regulatory data are more critical as global regulations continue to change and become more complex. Getting a medical device to market is a difficult process, but RIM software cuts the time and costs associated with product registrations while providing tools essential for ensuring ongoing compliance. Choosing a RIM system designed specifically for the medtech industry will provide your RA team with the tools they need. To get your regulatory ducks in a row, only a RIM system will do!

To learn more about the Rimsys RIM system, talk to one of our experts today.

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The lifecycle of a medical device

The time from when a medical device enters the market to the time it leaves, and the business and regulatory processes associated with that journey, are referred to as a product lifecycle. Regulatory affairs (RA) professionals have responsibilities at each stage of the product lifecycle and will collaborate with most sections of the business on one or more activities. In this article, we discuss the regulatory responsibilities that are typical in a large, global medical device manufacturer.

Cross collaboration with RA across the globe

The Regulatory Affairs professional at the manufacturer often does not complete regulatory activities alone. Major medical manufacturers have RA employees stationed across the globe. The international RA employees or local distributor will provide insight into their country’s regulatory requirements and will often be the individuals that have direct contact with their country’s government agency.  

For example: When a manufacturer is working on a Registration in China, the Regulatory Affairs Engineer in the U.S. may be on an 8pm call coordinating with a Regulatory Affairs Professional in China.  

Manufacturing RA Responsibilities

• Provide details and information on the medical device.
• Assist in-country RA in providing manufacturing SME team support on governmental questions during submission review.
• Provide appropriate documentation from the SME teams to help complete the regulatory submission.

In-country RA Responsibilities

• Provide insight on the in-country medical device requirements.
• Identify Standards particular to the country.
• Manage in-country specific submission deliverables.
• Identify devices that need to be provided for in-country testing (if applicable).

Each major lifecycle stage – pre-market, market placement, and post-market – are discussed below.

Pre-market

Research and development

A new medical device begins with an idea for a product and an R&D process that will eventually include the quality and regulatory departments. Once designed, these devices are heavily tested to industry standards that are applicable to the device. Higher risk devices must also go through clinical trials before being brought to market. Information on compliance with standards and results from testing are included in the submission documents used to obtain market access.  

Each department plays a role in ensuring that a device and all supporting information is ready to request market entrance.

Regulatory responsibilities  

• Identify applicable standards that will apply to the new device.
• Collaborate with R&D to understand the functions of the new device.
• Identify the intended use of the device.
• Classify the device for major markets.
• Collaborate with in-country RA for any additional device testing.

R&D responsibilities

• Test the new device to the standards that regulatory tells them to or find a vendor that does that testing.
• Compile the testing reports.

Business role responsibilities

• Approve the financials for the R&D work.
• Have an initial scope of regions where the device would be sold.

Initial business case

In parallel to the R&D preparation, a business plan will be developed by the Sales and Marketing teams, along with the Product and Project Managers (“business” teams). The business plan will detail where a product will be distributed and sold. It is incredibly important for the regulatory team to have a full understanding of this plan as early as possible so that they can research regulatory requirements and develop a regulatory plan.

The initial business case is often a back-and-forth conversation between those developing the business plan and the manufacturing and regulatory teams. The business often asks and heavily relies on the regulatory professional to describe the submission processes per country, to note any particularly challenging country for registration, and to explain why there are more requirements in some markets.

Regulatory Responsibilities

• Notify the business of the cost of the submissions for all markets that the business intends to sell in (Market Access Submissions cost money).
• Notify the business of the cost of man-hours on a per-registration basis.
• Notify the business of the labeling costs.
• Translating the manual into multiple languages.
• Applying country-specific labeling on the package or on the device.

Business Responsibilities

• Make good financial decisions on go-to-market.
• Approve staffing resources for the regulatory activity.
• Create a priority for submission activity.

Regulatory Plan

The regulatory department creates a plan of how to gain market access based on the initial business case. For large expansive launches in many countries, a regulatory plan may need to consider over 100 country requirements, which often includes a phased approach to product launches.

Regulatory responsibilities are often split between the RA resources at the manufacturer and those that are in the country in which the device is being marketed. While they vary by company, responsibilities often look something like this:

Manufacturing RA responsibilities

• Draft the regulatory plan.
• Provide classification for country of origin and some major markets.
• Provide appropriate documentation from the SME teams to complete the regulatory submission.

In-country RA responsibilities

• Provide insight on the in-country medical device requirements.
• Classify the device per country standards.
• Identify in-country specific submission deliverables that need manufacturing SME support.
• Identify devices that need to be provided for in-country testing (if applicable).
• Provide timeline estimations for international submissions.

Initial pre-market submissions

In regulated markets, a company needs to “register” their device prior to shipping, selling or marketing a device in the country. These submissions often contain confidential business information and test reports that were identified as needed in the regulatory plan. Once the device is accepted, a certificate is given to the manufacturer allowing the product to be sold in that market.

Typically, manufacturers begin by registering in their country of origin and a small subset of highly marketable countries. This phase often includes the USA and EU. Once a majority of those submissions are completed, submissions to other markets are addressed in a phased approach. There can be multiple waves of these registrations, and the entire registration process can last for months. Registration projects also often overlap for the manufacturing regulatory professional.  

Manufacturing regulatory responsibilities

• Provide appropriate documentation from the SME teams to complete the regulatory submission.
• Notify SME teams when support is needed.
• Coordinate and compilate SME answers to governmental questions.
• Update the business on the submission progress.
• Notify the business when the submission is complete.

SME teams responsibilities

• Provide adequate information about the device per the regulatory plan.
• Notify the manufacturing regulatory team of any governmental questions and ask for support when needed.
• Notify the manufacturing regulatory team of submission progress.
• Provide SME support to develop the submission and answer governmental questions.

Business responsibilities

• Provide funding for this activity.

Expansion to the rest of the globe

Once the initial launch is completed or near completion, submission activity now begins in every other market that the business approves to launch in. For large and expansive businesses, this launch can be over 100 countries, which can mean 100 regulatory product registrations.  

Manufacturing regulatory responsibilities

• Provide appropriate device information to in-country RA for submission support.
• Notify SME teams when support is needed.
• Coordinate and compilate SME answers to governmental questions.
• Update the business on the submission progress.
• Notify the business when any submissions are complete.

In-country RA responsibilities

• Complete in-country submission deliverables.
• Identify standards particular to the country.
• Manage in-country specific submission deliverables.
• Identify devices that need to be provided for in-country testing (if applicable).

SME teams responsibilities

• Provide adequate information about the device per the regulatory plan.
• Provide SME support to develop the submission and answer governmental questions.

Rimsys provides regulatory teams with the ability to manage requirements, content plans, documents, and tasks for new registrations.

Marketing the device

Once a device is fully registered in the regulated country, it can be marketed. However, any marketing material that is created often goes through an additional legal and regulatory review as any inaccuracy can lead to fines for mislabeling the device.  

Manufacturing regulatory responsibilities

• Coordinate with clinical to ensure claims are aligned.
• Review marketing content to ensure regulatory compliance.
• Notify the business when approvals are received so marketing knows when they can begin marketing the device in that country.

Marketing responsibilities

• Create drafted content which could be product sheets, social media posts, or presentations for conferences.
• Accept regulatory review of the marketing materials.

Market placement

Change management

Businesses add features and change medical devices all of the time. They may shift where the manufacturing facility is located, add an accessory, change a motor - all of these changes need to be assessed and submission may need to be done prior to market entry for those changes. These changes also need to be assessed on a global scale. The more countries that are involved, the more complex that process is.  

For every change, a survey is often sent out to the in-country regulatory teams, and they are often responsible for completing that assessment for their country. These are typically called impact surveys. It is then up to the RA team at the manufacturer to compile those responses and to receive approval from the business to complete any additional submissions to governments that may be required.

R&D responsibilities

• R&D and project teams determine a change is needed.
• Notify the manufacturing regulatory team of the upcoming change.

Manufacturing regulatory responsibilities

• Fully understand the change that is coming from R&D.

In-country regulatory responsibilities

• In-country specialist completes the impact survey.
• Notify the manufacturing regulatory team if additional submission activity is needed, along with the timeline for that activity and the deliverables/support required.

Business responsibilities

• Approve the submission activity and finance it as needed.

Renewals

After the initial submission, most countries will require a renewal submission after a set number of years to keep the device in the market. It is critical that renewal dates are tracked and managed appropriately. Missed renewal dates may require several months to over a year of work to obtain market approval again. During that time, all sales of the product are stopped.  

Manufacturing regulatory responsibilities

• Notify the business of upcoming renewals.
• Coordinate with in-country RA to provide documents and assist in the submission for the renewal.
• Coordinate SME support for governmental questions if needed.

In-country regulatory responsibilities

• Notify manufacturing regulatory in a timely manner when renewals are needed.
• Submit the renewal to the government authority.

Business responsibilities  

• Approve the renewals.

Rimsys simplifies global submission management with integrated tools that provide complete control over submission authoring, assembly, and publishing.

Post-market

Audits

Governments and other regulatory bodies will often audit the medical device manufacturer to ensure that they are in compliance with current regulations.  

Manufacturing regulatory responsibilities

• Gathering device marketing registration history and facility registration for a specific set of countries to be presented by the auditor.
• Familiarizing yourself with the registrations and recent regulatory work that has occurred in the country to be prepared for auditor's questions.  
• Responding to auditors questions if you are on “Audit Duty”.

Quality department responsibilities  

• Manage the facility tour.
• Be responsible for the majority of the Quality Management System (QMS).

Research and development  

• Provide the subject matter expert (SME) with explanations of how testing was developed for the product and the outcomes of said testing.

Post-market surveillance and reporting

Manufacturers must have ways of accepting customer complaints. In certain cases, when the complaints relate to health and safety concerns pertaining to the device, the manufacturer may need to report these complaints to their government or other countries where the device is sold.  

Correctional activities (recalls)

If a company finds a health and safety risk to their device, the company as a whole may need to gather all of the devices that are affected and either repair them or destroy them.

Obsolescence

Obsoleting a product is often a regulatory step and a submission step as well. There are many reasons to take a device out of a market; low sales, new requirements causing additional work that is not financially feasible, or new devices being available that are part of a newer generation that are safer for the user are a few reasons.  

Business responsibilities

• Notify manufacturing RA and in-country marketing of the obsolescence of the device in the market.

Manufacturing RA responsibilities  

• Notify in-Country RA of the obsolescence and expected date that the business will stop supporting the device in that market.

In-country RA responsibilities  

• Submit obsolescence notification to the authority.

Learn more about how Rimsys supports the regulatory teams of some of the world’s leading Medtech companies.

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Regulatory affairs professionals at large medical device companies must manage heavy submission workloads, registrations for products currently on the market, and ever-changing regulatory requirements. Many RA teams are still relying on paper documents, spreadsheets, and other outdated tools and methods to complete this work, while others have taken steps toward digitization and automation of key processes.

Regulatory teams often struggle to find software tools designed specifically for their workflows. ERP (Enterprise Resource Planning) systems are sometimes used by RA teams to track product attributes, such as selling status and support/service history. ERP systems, however, are not designed to handle the complexities of regulatory workflows nor the type of data that needs to be securely managed within a medtech company.

What is ERP software?

Enterprise Resource Planning (ERP) software encompasses a wide range of systems that typically manage multiple sectors within an organization. Originally designed for manufacturers, ERP systems are now used by industries as varied as public utilities, wholesale distributors, service organizations, and retail companies.  

ERP systems manage the data and workflows associated with almost every sector within an organization, including:

• Manufacturing  
• Device identification/history
• Purchasing and sourcing
• Service delivery
• Finance
• Human resources
• Engineering
• Asset management
• Supply chain
• Customer management and sales

Modern ERP systems are designed to provide a single, integrated platform to manage the majority of functions within an organization. The trade-off, however, is that because functionality needs to meet the needs of a variety of organizations, it will often fall short in highly regulated industries that require very specific data, workflows, and controls.

What are RIM systems?

Regulatory information management (RIM) systems have been around for years in the pharmaceutical industry but are relatively new in the medical device industry. Holistic RIM systems enable users to create a single source of truth for all data associated with regulatory submissions and registration management. Think of a RIM system as an ERP system for regulatory teams that is used to digitize data and automate key processes across the organization.

Medtech RIM system functions are designed to support a range of regulatory activities across a product’s lifecycle. In addition to centralizing core regulatory data and managing regulatory registrations and certificates, RIM systems can also support:

• Submission planning, authoring, and assembly
• Collaborative content authoring and project management
• UDI management
• Standards management
• Essential principles/GSPR management, including bulk updating

RIM systems are product-centric, structuring data around individual regulated products and their requirements, market by market. This means that RIM systems can track product-specific data, such as UDI records, and link standards with individual products to easily identify products affected by standards updates and assess their impact.

Integrating ERP and RIM systems

The most common point of integration between ERP and RIM systems is an “available to sell” setting at the product level. Product information in a RIM system will include registration status for each country and an indication of whether the product can currently be marketed and sold there. It is critical that the ERP system restrict distribution and/or sale of a product automatically based on the selling status set by the regulatory team.

ERP systems will also often be integrated with Product Lifecycle Management (PLM) systems used by product development and manufacturing teams to manage product information and at every step of a product’s lifecycle, including product data, records, specifications, and configurations. ERP systems can also be integrated with eQMS (electronic quality management systems) and RIM systems to ensure coordination of risk management activities, product updates, and quality data between the regulatory, quality, development, and manufacturing teams. Ideally, your regulatory team is notified as early as possible of any planned updates or changes to a product that is in-market or pending market approval.

RIM for regulatory projects and processes

Digitization and automation of regulatory data are more critical as global regulations continue to change and become more complex. Getting a medical device to market is a difficult process, but RIM software cuts the time and costs associated with product registrations while providing tools essential for ensuring ongoing compliance. ERP systems are central to an organization’s operation, but their broad focus simply does not provide the detailed functionality needed by regulatory teams. Integrate your ERP system with a holistic RIM system to give your regulatory team the tools they need to bring your products to market successfully and to maintain compliance. To get your regulatory ducks in a row, only a RIM system will do!

To learn more about the Rimsys RIM system, talk to one of our experts today.

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