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Medical Device Risk Management Plan – What You Need to Know

by Ger O'Carroll

As we have covered in a previous blog, risk management is essential when designing and developing a new medical device product. An important part of this process involves creating and maintaining a risk management plan.

Before going any further, it’s helpful to define risk management. What is risk management?

Risk management is not the act of carrying out a risk analysis at various points during the design of your medical device. This is an action that is part of risk management.

Instead, risk management is a process and, for that process to be effective, documented, and transparent, you need a plan – a risk management plan.

An Introduction to Medical Device Risk Management Plans

A medical device risk management plan should be put together in the very early stages of the product development and design process.

You then must review and update the plan regularly as the development progresses. In other words, a risk management plan is a document that evolves along with the product.

Key Questions Answered

What Is a Medical Device Risk Management Plan?

A medical device risk management plan identifies and documents all the activities you plan to take to manage risks associated with your new medical device. Medical device risk management plans are product-level documents.

How Does a Medical Device Risk Management Plan Fit into the Risk Management Process?

Your risk management plan is a planning document and should be part of your medical device risk management file.

What Does a Risk Management File Include?

  • Risk management plan
  • Individual risk analyses
  • Risk evaluations
  • Risk control measures
  • Evaluation of risk acceptability
  • Risk management reports

What Does a Risk Management Plan Include?

A medical device risk management plan should contain six important sections:

1. Scope of the Risk Management Plan

In this section, you should define the scope of the risk management plan. This definition should include a detailed description of your medical device including who will use it, who benefits from it, its lifecycle, etc.

You should also include the more formal intended use definition of the product.

Other information that should be in this section includes details of the quality management system.

2. Roles and Responsibilities

This section should include details of the risk management team. These are the people who are responsible for all aspects of risk management in relation to your medical device.

This team needs to be qualified and experienced medical device product designers. They also must know everything about the device from how it’s made to what it does to how it is used.

3. Risk Management Activities

This section is for outlining the risk management activities you will take over the entire lifecycle of the product. This includes details of the risk evaluation and mitigation process as well as information about your quality management system.

4. Criteria You Will Use to Determine the Product’s Risk Acceptability

Outlining acceptable risks for your medical device product is an important step that you should document in your risk management plan. Specifically, you need to define quality standards, margins of deviation that are acceptable, and the requirements for approval whenever deviations occur.

5. Measures to Verify Risk Control

In this section of your medical device risk management plan, you should include the quality assurance activities you will use to ensure the proper implementation of risk control measures. Examples of those activities include:

  • Design verification and validation testing
  • Shelf-life testing
  • Packaging testing
  • Shipping testing
  • Process validation

6. Measures to Capture and Use Post-Production Information

As already mentioned, a medical device risk management plan is a living document that remains relevant after the product has gone into production. Therefore, you need to outline the post-production risk management activities you plan to take.

This includes how post-production information will be fed into the risk management process to further manage, control, and mitigate risks as well as to ensure continued improvements in product quality.

Creating a Medical Device Risk Management Plan

The team you appoint to design your new medical device product should lead the process to create a risk management plan and establish effective processes. You will still be a part of these activities, however, so it’s important you have a clear overview.

An Overview of Risk Management in Medical Device Product Design

by Ger O'Carroll

Risk management is an essential part of the medical device product design process. It ensures the safety of patients, users, and operators so it’s no surprise that risk management is a regulatory requirement.

Risk management is also essential to the medical and commercial success of the new product you plan to develop.

In terms of the processes and steps required to ensure the proper management of risk, this is part of the Quality System that you need to have in place when designing a medical device product.

In addition to risk management, a Quality System includes management controls, document control, and more.

Risk Management and Getting Regulatory Approval for a New Medical Device

Risk management is a complex part of the regulatory approval process. There are several reasons for this, not least the fact there are many different variables that can impact risk type and severity.

In addition, the analysis of risk is often subjective which means there can be many different interpretations of the same risk.

On the positive side, regulators around the world all use the international standard ISO 14971. This provides a common framework for risk management when designing a new medical device.

How Do You Define a Risk in Medical Device Product Design?

A risk is a combination of two things:

  1. The probability of a particular event, situation, or outcome occurring
  2. The severity of the consequences if the above happens

What is Risk Management in Medical Device Product Design?

Risk management in medical device product design involves taking a structured and documented approach to analysing, evaluating, controlling, and monitoring risks.

Why Is Risk Management Important?

We’ve already touched on the essential role risk management plays in the regulatory approval process. However, its importance goes much further than this.

When you are designing and developing a new medical device, you have an obligation to ensure patient safety. You also need to ensure the safety of the operator or user of the medical device product if that person is different from the patient or person getting the benefit.

From a regulatory, moral, and commercial standpoint, this safety must be proven beyond doubt.

The Risk Management Process in Medical Device Product Design

Risk management in medical device product design requires a plan at the beginning which eventually leads to a report at the end. The process in the middle is the most important.

There are four main steps in this process:

The Risk Management Process in Medical Device Product Design

 

  1. Identify risks
  2. Evaluate risks
  3. Control risks
  4. Monitor the controls

Let’s look at each in more detail.

1. Identify Risks

The types of risks you can identify include:

  • Risks in the design of the medical device
  • Risks in how the device is manufactured

Both are important. To start with, does the design of the product itself create risks? Hazards the design might present include biological, chemical, or mechanical energy hazards, with vibration being an example of the latter.

What about the manufacturing process? What if parts are assembled incorrectly? What if there is a lack of consistency in a particular manufacturing process? What is the risk of these things occurring and what impact will they have on safety let alone the quality and reputation of the product?

2. Evaluate Risks

Once you identify risks you need to score them. For example, you could assess risk as being high, medium, or low. This will be based on the probability of the risk occurring and how severe the consequences will be.

3. Control Risks

This stage involves putting in place controls to eliminate the risks deemed to be unacceptable. In the classification example of risk above, this could mean developing and implementing controls for risks classed as high and medium.

The control measures you put in place usually fall into one of the following three categories:

  1. Changing the design of the product
  2. Changing a manufacturing process
  3. Implementing protective measures on the product or in the manufacturing process. Examples of this type of control include providing instructions for use or warnings on the label.

4. Monitor the Controls

Monitoring risk management controls starts by verifying the control measures have been implemented. You then need to analyse the effectiveness of the controls. This often means re-evaluating the risk to determine if it is now within an acceptable range (i.e. low risk) or if further mitigation measures are required.

Documentation

Finally, it’s crucially important that all the above steps are properly documented. This means recording all the actions taken in each of the steps as well as the results and decisions.

These records are usually included in the design history file and ensure you not only properly carry out risk management, but that you have documented proof.

Medical Device Design Verification and Design Validation – What They Are and Why They Are Important

by Ger O'Carroll

Design verification and design validation are essential parts of the medical device product development process. Sometimes referred to as V&V, it’s important to understand what both terms mean and how they differ if you are about to embark on a medical device product development project.

This is because V&V can take more time than necessary if proper design controls are not put in place in the early stages of the design process.

In other words, both design verification and design validation are made easier if you have well-documented user needs, design inputs, design outputs, and outcomes from design reviews.

What Do the Terms Design Verification and Design Validation Mean?

Design verification and design validation are terms that are often used together, but they mean very different things.

You then need to add to this mix the fact there are many different types of verification and validation, some of which apply to medical device product design and some don’t.

Design validation is only one type of validation. Another, by way of example, is process validation, a topic we have covered in a previous blog.

In this blog, we are going to focus specifically on design verification and design validation as they apply to Design Controls.

These definitions will help you understand the difference:

  • Design verification confirms the device was designed correctly
  • Design validation confirms you designed the right device

Let’s look at both in more detail.

The Design Verification Process

The objective of design verification is to demonstrate your design outputs (i.e. the medical device product you have designed) meet the design inputs (which you derive from the process of defining user needs).

It is good at this point to reference an image from the FDA we have published previously. It is the design control waterflow diagram and it outlines the design control process:

Design control waterfall diagram

So, in summary:

  • You start by defining user needs
  • You then use the user needs definition to create design inputs, i.e. you define what you want to design
  • Then, you go through the design process
  • The result of the design process is the latest iteration of your medical device product – this is your design output
  • Verification should happen at this stage to ensure the design output matches the design input

How do you verify the design? Testing is often a big part, but design verification often also involves visual inspections and analysis.

As stated previously, having good documentation helps ensure the design verification process is as efficient as possible.

Another good strategy to ensure efficient design verification is to consider how you will verify design inputs before moving forward to the design process. In other words, you should think about and plan for design verification at the earliest possible stage.

The Design Validation Process

Design validation confirms you have designed the correct product. So, design validation must refer all the way back to user needs.

Defining user needs is one of the first things you must do in the medical device product design process. The things this definition will contain includes:

  • The medical device product’s purpose
  • What the medical device does
  • The diseases, conditions, circumstances, or situations where the product will be used
  • Whether the medical device treats, prevents, cures, diagnoses, or mitigates
  • The type of patient who will benefit from the product

Design validation ensures the medical device design meets your user needs definition.

Design validation usually occurs when you are in the final iterations of the design process and it usually involves using a small batch production run of the product.

Importantly, the product must be fully produced including all packaging, labelling, usage instructions, and anything else that will be with the product when it is launched on the market. Everything must be validated.

The process itself usually involves clinical evaluation which often includes either clinical trials or simulated trials using, for example, mathematical modelling.

Another common approach is to compare the medical device product with a similar product already on the market that is used for a similar purpose.

Inspections and analysis are part of the process too, but testing is the most important method of design validation.

The Importance of Design Verification and Design Validation

Both design verification and design validation are essential processes to go through and document to ensure your new medical device product gets regulatory approval. The processes also improve the design of your product to give it the best possible chance of success.

Documenting User Needs – Key Questions You Need to Answer

by Ger O'Carroll

In a previous article, we outlined the importance of identifying and documenting user needs when designing a new medical device product. In that article, we looked at the two objectives you must achieve when documenting user needs:

  1. Defining the intended use of your new medical device product
  2. Defining the indication for use of your medical device product

This sounds straightforward enough but when you go through it in practice, the process can be quite tricky, not least because documenting it is a regulatory requirement.

So, how do you create the above definitions to complete the process of documenting user needs? An effective approach is to ask and answer a series of questions about your product including how and when it will be used, and who will use it.

Questions to Ask When Documenting User Needs

Here are some examples of the questions you should ask. This is not an exhaustive list, and some may not apply to your product, but they will give you an indication of the process you must go through.

  • What does the product do?
  • What conditions, symptoms, and diseases is the product designed for?
  • Is the product designed to diagnose, prevent, mitigate, treat, or cure?
  • Who will benefit from the product? When considering this question, think about the condition, disease, or symptoms the beneficiary suffers from, even if those conditions, diseases, or symptoms are not directly related to the product. Also think about things like age and gender as well as other defining characteristics.
  • Who will use your product?
  • Is the user of the product different to the person benefiting, i.e. is the user a medical professional or other third-party, or does the patient use the product on themselves? If the user is different from the beneficiary, who will be using your product?
  • When will the product be used?
  • In what circumstances will the product be used? For example, will it be used under clinical supervision, in a sterile environment, in an emergency situation, etc? Think of the environment, the people who will be involved, other people who might be nearby, etc.
  • Will the user use all the product’s features?
  • What are the stages the user will go through in order to use the product, i.e. remove packaging, remove safety features, prime the device, etc?
  • How will the user interact with the product?
  • If the user and the patient are different people, how will the patient interact with the product?
  • How long will these interactions last?
  • Does the product interact with other devices? What are the implications of that interaction?
  • How often will the patient need to use the product?
  • Will the patient use the product multiple times, or will they require a new product for each use?
  • If the product can be used multiple times, is there a maximum, or recommended maximum, number of uses?
  • How will used versions of the product be safely disposed of?

Documenting User Needs

Remember, you shouldn’t just think about the answers to these questions. Instead, you should also document your answers, so you have a record.

Don’t worry about the wording you use or the thoroughness of your answers. The key is to demonstrate and provide proof of the thought process that went into defining the user needs that your new medical device product addresses.

If you have an idea for a new medical device product and would like to speak to one of the product design and development experts on our team, contact us at Arrotek today.

How Design Changes Impact Medical Device Product Development Costs and Time to Market

by Ger O'Carroll

You have an idea for a new medical device – this is the starting point for all new product development projects. Where the project goes from there, however, the costs involved, and the timeline depends on a range of factors.

Examples include the complexity of the product, availability of funding, regulatory issues, medical trials, and more. Unfortunately, you have limited control over many of these factors.

That said, there is another factor that can have a substantial impact on the cost of product design as well as the time it takes to bring your new medical device to market. As an innovator, inventor, or entrepreneur with an idea for a new medical device, you do have significant influence over this factor.

Design Changes – a Necessary Part of New Medical Device Product Design

The factor we are talking about is design changes. This can be anything from superficial visual tweaks to major changes in how the product works or is used.

Making design changes is not only a part of the product design process – it is an essential part.

After all, an iterative design process is crucial to improving your product and ensuring it performs according to its intended use.

In other words, design changes to improve your product are important to making the product a success.

Crucially, however, the impact of design changes on development costs and timescales differs substantially depending on when those design changes take place.

The Earlier the Better

There is a well-known cost of design changes graph in the product design industry. It shows the potential cost difference of making design changes at various stages of a product’s lifecycle. Here is a representation of the image:

Cost of design changes graph

In summary, the later you make a change in the design of your product, the greater the cost.

We’re not talking small increases in cost here, either, as changes after the design is frozen and production tooling has been created can be thousands of times more expensive than making a change in the concept stage of the product’s development.

Impact on Time to Market of Late-Stage Design Changes

In addition to the cost implications, the later a design change occurs, the more work has to be redone. The change request could impact other aspects of the medical device too, meaning those aspects will also have to be reworked.

For example, a component might have to be redesigned to facilitate the design change but redesigning this component might also necessitate the redesigning of other components. This adds time to the development process.

In addition, design changes often mean new 3D models or CAD drawings have to be created. New prototypes of the product will have to be produced too if the design change request comes in after the prototyping stage.

It’s also likely the product will need to go through the verification process again and may even need re-validated. This causes further delays.

It’s easy in these situations for a product development timescale to drift by weeks or even months.

The Solution – and the Influence You Have

The straightforward solution to preventing these problems from occurring is to make decisions as early in the design process as possible.

At Arrotek, we have a six-step product design process to facilitate this decision-making. The aim is to establish an iterative design process, provide you with expertise from our design engineers, and encourage your feedback.

The process also involves getting sign-off at each step before moving forward to the next one, eliminating the unnecessary reworking of elements and the time delays that result.

Our experienced product design project managers lead the six-step process as we turn your idea into a working product. You play a critical role, however, particularly in relation to ensuring decisions are made early and are then adhered to.

By following this approach, you will keep a cap on design and development costs, and you will keep to your schedule for bringing the product to market.

What You Need to Know About User Needs When Designing a New Medical Device

by Ger O'Carroll

When you first came up with your idea for a new medical device, you probably had a fairly clear picture of how it could help improve health outcomes. In the medical device product design process, this is known as User Needs.

What often happens next, however, is new ideas start to come to mind. For example, you might think of other clinical areas or conditions that your new medical device product could help with. Or you might come up with ideas for alterations you could potentially make to the product further down the road that would make it even more beneficial.

This is all before you’ve seen a concept drawing let alone a physical prototype.

The Importance of Documenting User Needs

The above is why identifying, defining, and properly documenting User Needs is so important.

Firstly, it helps focus the medical device product design and development process, ensuring it is as efficient and effective as possible.

Defining User Needs also improves the quality and performance of the product that is ultimately developed, and it aids the regulatory approval process.

Understanding User Needs

In a previous blog, we looked at Quality Systems and design controls. Defining User Needs is an essential part of the design controls you put in place within your Quality System.

The central focus of doing this is that you need to be able to prove your new medical device product does what you claim it does and is suitable for its intended uses.

This brings us to two phrases you are likely to encounter during the medical device product design process: intended use and indications for use. As part of documenting User Needs, you will need to define both.

The Intended Use of Your New Medical Device Product

This involves describing the specific purpose of your new medical device product and what it does.

Importantly, however, you should not include things your new product could be used for. Instead, concentrate solely on the primary use you envisage.

The Indications for Use of Your Medical Device Product

Defining the indications for use of your medical device product involves outlining the situations, circumstances, diseases, and/or conditions where your product can be used to treat, mitigate, diagnose, cure, or prevent.

It’s also important you describe the patient group you are designing the medical device product for.

Why It’s Important to Define User Needs

We’ve already touched on this above, i.e. defining User Needs prevents drift in the design process and it reduces the risk of going off on tangents.

Staying focused on developing a product specifically aimed at addressing the defined User Needs also keeps the development process on track and improves the quality of the finished product.

We also mentioned the regulatory approval process above.

To understand this further, have a look at the image below.

Design control waterfall diagram

This is from the Design Control Guidance for Medical Device Manufacturers document published by the FDA in the US.

It is known in the industry as the design control waterfall diagram.

And at the top of the waterfall is… User Needs.

So, the User Needs definition leads to design inputs, the design process, and the design outputs (concepts, drawings, 3D models, prototypes, etc). Verification then takes place with the design process continuing through as many iterations as required before the final medical device product is finalised.

This final product is then validated based on the defined User Needs.

In other words:

  • Does the product perform according to its intended use definition?
  • Is it suitable for the situations you described when identifying its indications for use?
  • Can you prove both of the above?

As you can see, defining User Needs is a crucial early step in the medical device design process. Your development team will be able to help with this step but in a future blog we’ll look at how to document User Needs.

Understanding Process Validation in Medical Device Product Design

by Ger O'Carroll

If you have looked into the steps involved to design and develop a new medical device product, you are likely to have come across the term process validation.

It’s an essential term and concept to understand as it helps ensure your design, develop, and then manufacture a product that meets the needs of end-users – usually patients or customers. Process validation is also crucial to getting regulatory approval for your product.

What Is Process Validation?

Process validation takes place throughout the product’s entire lifecycle, starting during the design stage. It involves collecting and then evaluating data to prove the product produced is high-quality, repeatable, consistent, and meets the needs of end-users.

The Difference Between Process Validation and Verification

Another term you may have come across is verification. It is also important and is another requirement of regulators. Understanding the basic difference between the two terms – process validation and verification – can help with grasping the concept of process validation.

In basic terms, verification involves assessing whether a manufactured medical device product, or a component of a product, meets the defined specification. So, it involves physically inspecting the product to check the material, tolerance levels, dimensions, etc. This is then compared to confirm everything is within the defined parameters.

This doesn’t tell you if the product meets the needs of end-users, however. All it tells you is the product was manufactured to the intended standard.

Furthermore, verification becomes cumbersome when you have a complex medical device with multiple parts as it can be hard to verify each part.

For example, with verification, you might be able to confirm a tube and a handle are individually manufactured according to specification, but you can’t confirm that the handle and tube won’t detach during use, leaving the tube inside a patient. Process validation, however, can confirm this.

That said, verification is still important. Regulators offer guidance on when it is appropriate to use verification and when you should use process validation instead.

Process Validation in the Design Stage

Process validation happens firstly in the design and development stages of a new medical device product. Continued process validation then takes place once the product is in production and is being sold in the market.

In the design stage, process validation typically happens once the design of the product is locked down.

A crucial part of process validation is to use DFM (Design for Manufacturing) principles. DFM is about ensuring the product can be efficiently and cost-effectively manufactured. In many respects, therefore, the objectives of process validation and DFM are aligned.

At Arrotek, our services include:

  • Designing and developing medical device products
  • Manufacturing medical device products

Sometimes the products we manufacture are designed elsewhere. This has given us detailed insight into how bad design, where DFM is ignored, impacts product quality which, in turn, makes process validation more difficult.

By way of example, one of the things we do at Arrotek during the process validation stage of a design project is to reduce to a minimum the number of components and process steps it takes to manufacture a product.

This is not only good DFM practice, but it also reduces the possibility of things going wrong with the product during use, i.e. it helps ensure the product meets the needs of end-users, which is the goal of process validation.

The Best Approach

From your point of view, the key is to work with a medical device design company that has skills, experience, and knowledge in several crucial areas. This includes:

  • Medical device product design and development
  • Obtaining regulatory approval
  • Quality, including the implementation of quality systems
  • Manufacturing

This will make process validation more straightforward and it will ensure you get a better quality and more fit for purpose product.

How Long Does It Take to Design a New Medical Device Product?

by Ger O'Carroll

A question we are often asked at Arrotek is how long it takes to design a new medical device product. Knowing this helps entrepreneurs and businesses plan future steps, including those that come after the product is designed, including putting the product through clinical trials.

The problem with answering the question of how long medical device design takes is that it is variable.

The simple answer is three to six months.

To understand further, it helps to explain our process, the things that can cause delays, and how we mitigate those delays.

How We Work

At Arrotek, we put a schedule in place when we begin a new medical device design project. This includes the various stages of the process, with each stage requiring sign-off from the client.

A project manager will also be assigned to your project who will keep in regular touch to ensure you are updated. This is usually via a weekly telephone or conference call.

The project manager will also present the design work at the completion of each stage. A PowerPoint presentation is typically used in these meetings. You will be required to make a decision (to select a concept idea to move forward with, for example), give feedback, and/or sign-off the stage so the design team working on your project can move to the next one.

Crucially, if there are any issues that cause schedule slippages from our side, we communicate with you immediately to ensure you know as soon as possible.

Causes for Delay

In the vast majority of projects, however, schedule slippages where we encounter an issue at Arrotek are rare. There are other factors, however, that can, if not properly addressed, cause a project to fall behind schedule. The two most common are:

  • Inefficient approval processes
  • Going off on tangents

Streamlining the Approvals Process

Getting approval from you as the client is essential to ensuring the project stays on track. This is because it eliminates the risk of us having to go back to make changes because of something you are not happy with.

That said, the approvals process itself can introduce delays to a project. This is particularly the case when there are several people involved in the process. It is exacerbated further when some of those people cannot attend a presentation by the engineer managing your project.

As a result, we will discuss with you at the outset ways we can streamline the approvals process and make it as efficient as possible.

Staying Focused

At Arrotek, our clients include creative, innovative, and inspiring entrepreneurs who come up with fantastic ideas. Designing a medical device product, however, requires focus on specific requirements. Therefore, new ideas introduced during the design stage slow the process down.

One of the first things we do, therefore, is to define the project’s requirements. This helps our design and engineering teams to maintain focus and deliver according to the agreed schedule.

Successful Project Delivery

There are variables that impact all medical device design projects. At Arrotek, however, we have tried and tested methods, developed over many years, that ensure the successful delivery of the projects we work on. This includes keeping projects on schedule.

FDA Medical Device Classifications Explained

by Ger O'Carroll

To sell a medical device product in the US, you need approval from the FDA (the Food and Drug Administration). A key part of getting FDA approval is the classification of your medical device.

Not only will the classification determine much of the design and development process, it will also determine what is required to get approval. This is because the process for getting FDA approval differs depending on the classification of your medical device.

This is very similar to the system in the EU. We covered the EU medical device classification system in a previous blog. In this one, we will concentrate on getting regulatory approval for the US market.

FDA Medical Device Classifications for the US Market

The US has three classifications for medical device products: Class I, Class II, and Class III. As in the EU, the process for determining the classification of a medical device is based on risk, while the classification itself determines what you need to do to bring the product to market.

  • Class I – as with EU regulations, this classification is for the lowest risk medical devices, i.e. surgical caps, toothbrushes, crutches, etc.
  • Class II – this classification is for higher risk medical devices such as catheters, ECG machines, syringes, etc.
  • Class III – Class III is for the highest risk medical device products such as defibrillators, implanted prosthesis, heart valves, etc.

Class I Medical Devices

There is no requirement to notify the FDA when bringing a Class I medical device to the US market. Instead, you must adhere to the FDA’s General Controls. This includes complying with good manufacturing practice, listing requirements, and more.

In fact, all medical device products in the US must comply with the FDA’s General Controls.

Class II Medical Devices

The process of bringing a Class II medical device product to market is more involved and more time-consuming than with Class I medical devices. This is because, in general, Class II medical device products need to go through the FDA’s Premarket Notification application process.

The Premarket Notification process involves showing your medical device is equivalent to another medical device that already has regulatory approval. This equivalence demonstrates the safety and effectiveness of your product.

However, the FDA also produces a list of common Class II medical devices which don’t require Premarket Notification. Instead, they must adhere to the regulator’s other requirements for these types of devices. If your product falls within the scope of this list, getting it to market in the US is much simpler.

Class III Medical Devices

The process for getting FDA approval for a Class III medical device is much more rigorous than with products in the other two categories. This is because Class III medical devices must go through a Premarket Approval process.

The Premarket Approval process is significantly different from the Premarket Notification requirements for Class II medical devices.

In the Premarket Approval process, your medical device will need to go through rigorous study and testing to determine both its effectiveness and its safety. This process can – and often does – include clinical trials.

Getting Approval in Multiple Jurisdictions

Most entrepreneurs, medical professionals, and companies with an idea for a new medical device have the objective that it will be sold and used in multiple countries. High up on the priority list is usually the US and EU markets.

Therefore, it’s important you work with a medical device design and development team that understands both US and EU medical device classifications and regulations, in addition to regulations in other major jurisdictions around the world.

This is what you get with us at Arrotek. Contact us today to find out more.

EU Medical Device Classifications Explained

by Ger O'Carroll

Not all medical devices are the same. Some are non-sterile and pose minimal risk to patients, while others are implanted in the body and carry a high risk. Therefore, regulations for medical devices must distinguish between the different types, setting appropriate requirements for regulatory approval depending on risk. Regulators do this with a classification system.

In other words, understanding the classification that your new medical device falls under is a crucial step in the design and development process. The classification will inform how the development progresses as well as the steps required to obtain regulatory approval.

EU vs US Regulations

In the EU, new EU regulations, known as the new EU Medical Device Regulations, or MDR, are coming into force. One of the main changes in the new regulations involves different rules on the way medical devices are classified.

If you have gone through the process of designing and developing a medical device before, you might find it different with the new EU MDR. For example, the medical device you want to develop might now fall into a higher classification.

If you are going through the process for the first time, however, the changes in EU regulations will have less of an impact. One exception to this is the fact the new EU MDR brings the classification of medical devices in Europe more in line with international regulations. This includes FDA regulations which apply in the US.

There are still some differences, particularly in relation to how you get regulatory approval in the EU compared to the US, but the closer alignment of the two systems has simplified many aspects.

We’ll look at the classification system in the US in more detail in a future blog. The focus here is on medical device classifications in the new EU MDR.

EU MDR Medical Device Classifications

The classification system for medical devices under the new EU MDR is based on risk. The level of risk the medical device presents determines which classification it falls under. This classification then tells you:

  • Whether a conformity assessment is required to ensure it meets MDR requirements; and,
  • If a conformity assessment is required, how that should be done.

If a conformity assessment is required, it must be conducted by a Notified Body, i.e. an independent certification organisation authorised – i.e. notified – by an EU member state.

There are three main classifications for medical devices: Class I, Class II, and Class III. In addition, there are sub-classes such as, for example, Class IIb and Class IIa.

Most medical devices, however, will fall into the following risk classes:

  • Class I – this classification is for the lowest risk medical devices such as wheelchairs, glasses, stethoscopes, etc. Most medical devices in this category do not require a conformity assessment. Instead, they can be self-assessed. The exceptions are Class I medical devices which are reusable surgical instruments, are supplied sterile, or have a measuring function. A notified body is required to certify these types of medical device.
  • Class IIa – this classification is for medium risk medical devices. An example is a surgical clamp. A conformity assessment by a notified body is required for this classification of medical device.
  • Class IIb – this classification is for higher risk medical devices or medical devices classed as a medium-to-high risk. A bone fixation plate is one example. Again, Class IIb medical devices require a conformity assessment.
  • Class III – this classification is for the highest risk medical devices and requires a conformity assessment. Examples include pacemakers and heart valves.

Determining the Classification of Your Medical Device

One of the first things that is required when designing and developing a new medical device for the EU market is to determine its classification. Working with an engineering design and development team with knowledge and experience in this area streamlines the regulatory approval process and ensures the development starts on the right track.