Category: regulatory-operations

If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company must first ensure that the device is in compliance with each target region’s medical device classification requirements.

Determining the classification of a medical device can be tricky. However, medical device companies can use this comprehensive guide to understand medical device categories and where their products fall in line.

A basic understanding of regulatory product classification will become highly beneficial for manufacturers intending to become part of the medical device industry. Producers should consider the information below before introducing new products to the U.S. or European markets.

The Basics of Medical Device Regulations and Classifications

According to the European Commission, a medical device is any product or piece of equipment intended for use as a medical purpose. According to the U.S. Food and Drug Administration (FDA), the explanation of a medical device is a bit more detailed.

Based on the information within Section 201(h) of the U.S. Food, Drug, and Cosmetic Act, a medical device is an instrument, appliance, implement, machine, implant, in vitro reagent, or another similar related article:

• Intended to diagnose, mitigate, cure, prevent, or treat disease in humans or animals
• Designed to alter the structure or function of a human or animal body
• Recognized in the U.S. Pharmacopoeia or the official National Formulary

By these definitions, medical devices can range from a basic cotton swab for COVID testing to a complex kidney hemodialysis machine. However, every device falls under the regulations of one or more regulatory agencies, such as the FDA in the United States and The European Commission’s European Medicines Agency (EMA).

These agencies have the responsibility to create laws to govern the manufacturing, distribution, and use of medical devices. The purpose of these laws is to ensure the safety and effectiveness of medical products, so all companies need to adhere to regulatory requirements the agencies set forth. The European Commission and its Member States began operating under a new policy framework as of May 2021, called the Medical Device Regulation (MDR).

The rules that would govern any new medical device depend on how the FDA and European Commission classify the products. Each agency has its distinct definitions of medical device classes, which generally outlines different product types’ perceived risk factors.

The FDA and European Commission have separate medical device categories. However, a class of medical devices will likely share similarities across both agencies, but with notable differences. Those responsible for introducing, marketing, and distributing new medical devices need to become very familiar with the legal policies and classifications of each agency.

How Does a Classification System Help Manufacturers?

The medical device classification systems and regulations help guide manufacturers in the following ways:

• Regulations clarify requirements affecting product development, design controls, and the manufacturing process before selling a product to a particular market.
• Knowledge of regulations helps a manufacturer to better predict costs and time frame for introducing a product to the market.

Understanding product classification benefits you as a medical device manufacturer or seller. Although multiple global regulatory agencies exist, we will focus on the primary two for this article: the U.S. FDA and The European Commission’s EMA.

Medical Device Classes in the United States

The U.S. Food and Drug Administration

The federal Food and Drug Administration is responsible for regulating medical devices in the United States through its sub-agency the Center for Devices and Radiological Health (CDRH). The CDRH states its mission as ensuring “safe, effective, and high-quality medical devices and safe radiation-emitting products.”

Due to the nature of their missions, the U.S. government mandates that the CDRH and FDA will ensure that all medical devices in the country are safe for use by providing the medical device manufacturing industry with “predictable, consistent, transparent, and efficient regulatory pathways.”

The FDA assigns medical devices to one of three classes. It bases its classification on the level of control that is necessary to make sure the device is safe and effective, as follows:

• Class I: General Controls
• Class II: General Controls and Special Controls
• Class III: General Controls and Premarket Approval

A product’s assignment within the medical device classification system will determine the type of general controls necessary to regulate the devices. It will also determine the required type of premarketing submission or application for the FDA’s clearance to market a device.

Device classification relates to both the intended use and the indications for use of medical products.

• Intended use refers to the general purpose of a medical product or what the manufacturer claim its function to be for patients or medical professionals.
• Indications for use are the diseases or conditions the product will purportedly diagnose, treat, mitigate, cure, or prevent, associated with a description of the target patient population.

In other words, the intended use is all about the purpose of a medical device, while indications for use refer to what the product does to a particular illness or condition. A medical device’s intended use and indications for use directly correlate to the idea of the product a manufacturer wants to market.

Classification is also risk-based—that is, how much risk does the device pose to the patient or user?  Class I devices will carry the lowest risk, while Class III devices will present the highest risk.

How to Locate FDA Regulations for a Medical Device

Once a manufacturer can explicitly define the intended use and implications of use for a particular new medical device, they must locate FDA regulations and product codes that relate to their product. An FDA product code is a five- to seven-character figure containing numbers and letters. The agency uses it to describe a specific product.

It may take some time to identify a product’s regulatory classification with the FDA. The agency has several medical device categories based on medical specialties in CFR Title 21 – Food and Drugs: Parts 862 to 892. Examples of the specialties and regulation numbers include:

• 862 Clinical chemistry and clinical toxicology devices
• 864 Hematology and pathology devices
• 866 Immunology and microbiology devices
• 868 Anesthesiology devices
• 870 Cardiovascular devices

A searcher should use the medical device’s definition for the intended use and implications for use to determine which category it best represents. Click the FDA regulation number to uncover a seemingly endless list of medical device possibilities.

Each regulation number opens a list of medical device descriptions. The manufacturer should there be able to find a suitable regulation for the product in question.

For each item on the list, a link opens up to provide more details about the regulations for that category, including the medical device classification and how well an intended use and implications for use line up with the rules.

After matching a proposed device with a regulation number on the list, a manufacturer must submit documentation, usually a 510(k), to the FDA in hopes of receiving market clearance.

Determining Applicable Product Codes for a Medical Device

After locating the applicable regulation and classification for a proposed new medical device, the next step is to find the applicable product codes. A search begins by going to the FDA Product Classification Database online and entering the regulation number from the previous search.

If multiple numbers appear to apply to the proposed medical device, the following process may be necessary for each number. After the number input, a search should generate a list of possible product codes. Clicking on each code should reveal more details about it. Using this process should help a manufacturer determine the best code for a specific medical device.

Understand a Medical Device’s Path to the U.S. Market

Knowing the application and product code for a medical device is necessary for determining a product’s classification and determining which path to take to register a product with the FDA.

Not everyone can register a medical device with the FDA. The process is more complex than merely submitting a basic application to the agency. Instead, the FDA uses three regulatory controls for all medical device classes:

• General Controls are for Class I medical devices that are low to moderate risk
• Special Controls are for Class II medical devices that are moderate to high risk. General controls also apply.
• Premarket Approval (PMA) is for Class III medical devices that are high risk. General controls also apply.

If a manufacturer’s research determines that their specific medical device is “exempt,” it falls under general controls, and formal submission of an FDA 510(k) form will not be necessary. An exemption means the FDA does not require the manufacturer to provide reasonable assurance that the medical device is safe and effective. It usually applies to Class I devices.

An exemption means the manufacturer will not have to file a 510(k) form but still must register the brand with the FDA and list the product. If the product requires special controls, the manufacturer will need to submit a 510(k) to the agency. The FDA will need to provide the company with clearance before it can put the medical device on the market.

Devices that require premarket approval (PMA) must follow the FDA’s PMA process before going on the market. Through it all, the manufacturing company should register with the agency.

FDA 510(k) Submission vs. PMA Submission

Understanding the differences between a 510(k) and PMA submission adds to the complexity of medical device classification. Medical device classes will correspond to the specific premarket classifications named above, with the following stipulations:

• Class I: These medical devices are basic and pose little to no risk to the user. General controls are acceptable for this class, and premarket submissions are unnecessary.
• Class II: Products in this class can have a moderate risk to users, which is why all Class II devices require a remarket notification by way of a 510(k) form. Otherwise, they cannot legally go on the market. Devices in this category include sutures, powered wheelchairs, and pregnancy tests.
• Class III: These devices have a higher risk for users than products in other categories because they sustain life or a medical professional can implant them into a patient. Examples include blood vessel stents and pacemakers. Class III devices must have a PMA submission before going on the market in the U.S.

When a manufacturer prepares and submits a 510(k), they must provide the FDA with documented evidence that proves the medical device is equivalent to a device that already has FDA approval. It usually takes the agency 30 to 90 days to review and approve these applications, after which the submission will be on display within the FDA 510(k) database.

To prove equivalency between a new medical device and another on the market requires comparing and contrasting the two devices, usually through laboratory testing. Helpful inputs to consider for a 510(k) submission include details from the documented Design Controls process, design inputs, intended use, and indications for use.

A PMA requires substantially more information than a 510(k) because devices that require premarket approval have a high risk. The PMA form proves to the FDA that a new medical device has exceptional safety and effectiveness for patients. Establishing this information usually requires laboratory testing and clinical trials with human participants.

Since the standards for a PMA are substantially higher than for a 510(k) submission, the FDA can take up to 180 days to accept or reject an application.

Medical Device Classes for European Union Member States

European Union’s Medical Device Regulation (MDR)

For countries within the European Union (EU), the Medical Device Directives by the European Commission now regulate medical devices.

Please note that since the United Kingdom left the European Union on January 31, 2020, it has its own medical device approval process that manufacturers must follow to receive a UKCA mark.

Within the EU, if a manufacturing company wants to make or distribute medical devices, it must obtain a CE marking. An EU medical device classification is necessary before obtaining a CE marking. The essential information for determining a medical device’s class is available in the European Union’s Medical Device Regulation (EU MDR).

As of May 2021, the EU MDR, specifically its Regulation EU 2017 /745, has become the mandatory regulation for medical devices. It amends the previous Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009.

The European Commission categorizes devices as Classes I, IIa, IIb, or III, depending upon the intended purpose and the device’s inherent risks.

Class I devices also break down into three subclasses: Is (sterile condition), Im (measuring function), and Ir (reusable surgical). Implantable devices and Class III devices require a mandatory premarket clinical investigation. A clinical evaluation consultation procedure is a requirement for certain Class III and Class IIb devices.

Under the EU MDR, a manufacturer should determine if a medical device is:

• Non-Invasive: A medical device that does not enter a patient’s body through an orifice or the surface of their body. Non-invasive devices usually fall under Class I, but some rules can make them Class II or higher.
• Invasive: These devices can enter a patient’s body, in whole or in part, either through the body’s surface or any orifice.
• Active: These medical devices are active if their operation depends on an energy source other than what the patient’s body can generate for that purpose.

Although these categories are relatively broad, they come with specific rules, explained in the new medical device regulation.

In addition, a medical device that has continuous use for less than 60 minutes has a transient duration. Products with a duration for use between 60 minutes and 30 days are short-term. Durations exceeding 30 days are long-term.

It becomes easier to determine a medical device’s EU classification with those definitions in mind. In addition, the Medical Device Coordination Group published MDCG 2021-24 Guidance on classification of medical devices in October 2021. The MDCG, a group consisting of representatives from all EU Member States, resulted from the terms of Article 103 of Regulation (EU) 2017/745.

This document explains the basis of the EU MDR Classification Rules as “a set of criteria that can be combined in various ways in order to determine classification,” including examples such as:

• Duration of contact with the body
• Degree of invasiveness
• Local vs. systemic effect
• Potential toxicity
• The part of the body the device affects
• The degree to which the device depends on a source of energy

Understanding Your Medical Device’s Path to the EU Market

For any medical device to have a legal spot on the European Union market, the manufacturer must prepare and provide technical documentation to meet all general safety and performance requirements. The company must obtain a CE marking, a Unique Device Identifier (UDI) number, and registration within the electronic system (in accordance with MDR Article 29). Implantable devices have additional requirements.

Finally, the manufacturing firm must follow reporting requirements under the medical device vigilance system. Post-market surveillance is an ongoing requirement, meaning that all manufacturers must keep their clinical evaluations updated with relevant information stemming from post-market clinical follow-ups.

All companies need to work with an Authorized Representative to register their products in Europe.

Final Thoughts

With the resources and guidelines in this article, a manufacturing company should be able to take the appropriate path to the medical device industry’s biggest marketplaces in the United States and throughout the European Union.

Complying with regulations will ensure that a product’s quality and reputation remain top-notch, and it plays a role in the success of any manufacturing business.

Essenvia: Simplifying US FDA and EU MDR Applications

Regulatory agencies like the FDA and European Commission reject many medical device applications because of technical errors, omissions, and inaccuracies. Essenvia‘s Regulatory Information Management platform will streamline your application by offering templates, collaboration, and additional support across your device’s life cycle.

Complete your 510(k) or MDR application and launch your device faster with Essenvia. Schedule a demo now to learn more about how Essenvia can help you reduce time to market for your medical device(s).

When you are in the early stages of developing a medical device, over half of your activities are regulatory-related. Therefore, having an optimized and efficient regulatory affairs operations is critical. It will be the difference between getting your device to market on time or suffering a crippling setback.

Automation is one of several key factors that allow you to optimize your entire regulatory affairs process. Without it, you leave yourself wide open to an array of potential mistakes. For example, manually compiling over 1,100 pages of content can lead to an accident such as omissions an discrepancies.

These critical errors can cause delays that cost your company thousands, if not millions of dollars. Depending on your current financial situation, that might be a type of loss your company cannot recover from. This type of financial setback can turn those avoidable missteps into fatal ones.

However, the right automation tool can transform your regulatory operations and make sure this never happens. The key is to invest in a platform that provides you with crucial submission insight. This includes a complete go-to-market strategy, understanding the required testing your device needs to complete, and more. Leveraging the power of automation is a choice you cannot afford not to make.

The Rapid Evolution of Regulatory Policies

Regulatory rules and policies change and shift at a rapid rate. Medical device companies are constantly facing the challenge of balancing these regulatory requirements with the commercial viability of the device they are bringing to market. Failing to strike the right balance in this area can be the difference between your device getting to market and watching it die before it even has a chance to succeed. It is up to a companies regulatory affairs team to balance these competing priorities.

However, a team is only as effective as the operational process they implement and follow. It’s important to understand the importance of an optimized regulatory process. To do this we must better understand the complexity and magnitude of the rapidly evolving library of regulatory requirements. Only then can we truly grasp the workflow required to manage the widening range of medical technologies.

The Role of Regulatory Affairs

The sheer number of relevant guidance documents, testing protocols, and submission checklists a regulatory affairs team must include in their submission presents a massive challenge. This high volume of data and information presents several potential areas for mistakes. If you are not careful, your chances for a successful pre-market application in jeopardy.

Not to mention, submitting regulatory submissions is only part of the job description for regulatory affairs specialists.. They also contribute to the regulatory strategy by gathering competitive intel using the FDA 510k database and coordinating with cross-functional teams.

They also must consistently monitor changes to product codes, guidance documents, and standards. This issue can be seen on full display when looking at the FDA’s refuse-to-accept rate when it comes to reviewing regulatory clearance applications.

A surprising 31.3% of applications get rejected before even initiating the review process and are forced to withdraw due to errors. This requires your team to go back into the 1,100+ page document, find and correct the mistakes, and start the process again. This delay in getting your device to market can cost your company millions of dollars.

Managing Your Cross-Functional Teams

It takes a village to manage the regulatory process for a medical device. While one person may run point on the entire project, they rely on significant help from their cross-functional teams. This includes design, labeling, sterilization, clinical and quality departments. For this type of collaboration to work, all relationships must be built on the following four pillars:

1. Ensuring everyone has access to the latest regulations, guidances, forms, and templates required by the regulatory authorities you are submitting into.

2. Following project management procedures that create a seamless workflow amongst all cross-functional teams.

3. Identify and eliminate/reduce repetitive manual tasks that only serve to delay progress and cause errors.

4. Establishing a relationship with a regulatory affairs expert who can provide specific guidance based on your device based and the regulatory testing required by the region you are launching in.

Setting up these pillars at the start of your regulatory pathway is vital. Once your initial regulatory strategy is set up, the cross-functional teams listed above will be responsible for supplying various types of documentation for your submission. The data and content will be based on several factors, including the type of device, applicable regulations, changes to the device, manufacturing site, materials, and more.

Having Access To The Latest Regulations Guidance Documents That Impact Your Device

The average length of a 510(k) submission has reached 1,185 pages. This is a staggering 150% increase since 2009 and a direct result CDRH’s actions to clarify and strengthen 510(k) submission expectations. The FDA and European Commission (EC) have issued hundreds combined new guidance documents with 50% of them being released in just the last two years alone.

These new guidance documents can have a significant impact in the trajectory of your device. Furthermore, these consistent updates force your regulatory team to spend 4-6 hours a week keeping up with the latest developments. This is a time that can be much better spent working with cross-functional teams to collect and review all content before it is added to the submission.

Guidance documents are crucial to the regulatory lifecycle of your device because they identify several key changes. This includes, but is not limited to: UDI Management, device registration, and listing management. Failure to stay up to date on these changes can result in the aforementioned fatal mistakes we mention earlier.

Eliminating Costly Mistakes and Expediting Time To Market

One of the most time-consuming parts of compiling a regulatory submission is collecting, organizing, and revising key content such as tables and graphs. In addition, once all of your tables and graphs are uploaded, you must make sure they are correctly numbered.

However, what happens when a team member sends you a new table or graph that needs to be placed amongst the assets you already have in place? This often results in having to go through and re-number the majority of the list. These types of manual tasks only serve to waste time and increase your chances of making a costly mistake.

Asset numbering is just one of several types of administrative tasks your team is responsible for executing. This type of extended manual labor increases the odds of making a crucial mistake. Furthermore, once everything has been double-checked, it is then time to publish your 1,100+ page submission into a format that the regulatory body will accept.

This administrative burden will add weeks to your regulatory submission timeline. Optimizing your process by using automation tools makes sure that does not happen. The right tool will re-number your remaining assets after an addition has been completed. Automation tools go through a complete checklist to ensure you have included every step you need to complete.

No matter how long you have been working on regulatory submissions, it’s unreasonable to think you can learn everything. This is because of how rapidly things change in the medical device regulatory industry. With everything else going on, you do not have time to keep on top of everything. Leveraging an automation tools makes sure every box is checked, every document is formatted correctly, and you end up with rejection-proof and regulatory body-abiding submission.

Having Access To An Expert That Understand The Regulatory Requirements For Your Device

While your team may be excellent at creating and organizing content and data, they will undoubtedly run into an issue they cannot solve independently. The regulatory requirements for each device vary based on several factors, and it can be challenging to understand which applies to your device. Optimizing your regulatory process becomes meaningless if you don’t understand which steps you need to take.

Regulatory consultants are external experts who have the knowledge and experience to help you understand the regulatory landscape for your specific device. They can also be beneficial depending on the location you are seeking clearance in. For example, if you seek clearance outside your primary country, you must work with an authorized representative in-country. The right regulatory expert can walk you through this entire complex process.

Let’s Recap

Optimizing your regulatory operations saves serious time and money. The regulatory lifecycle of your medical device is long and complex. Without automation, you are forced to perform tedious administrative tasks that open you to all types of errors and delays. The right automation tool takes all of this off your plate and provides the peace of mind you need to move forward to compile an accurate regulatory submission on time and under budget.

About Essenvia

Essenvia is a regulatory lifecycle management tool designed to help you automate the entire regulatory operation process. Our solutions include an innovative approach to building both your 510(k) and MDR submissions. Our software is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.

To better understand how your tool can benefit you, please schedule your free demo.