EU MDR Audit Readiness

Author: Trinity M Consulting, LLC. | | Categories: 510 K Submission , 510 K Write Up , Clinical Research Consulting Services , EU MDR , EU MDR Guidance , EU MDR Support , Medical Device Consulting Firm , Medical Writing Services , Project Management , Project Management Consulting Services , Regulatory Affairs Consulting Services , Regulatory Consultants , Regulatory Consulting Company , Regulatory Contractors , Regulatory Strategy , Talent Recruitment Consulting Services

Blog by Trinity M Consulting LLC

The deadline for EU MDR Audit Readiness has come and gone. Now, medical equipment manufacturers are operating in a new, amplified regulatory environment.

The EU MDR has changed how manufacturers, importers, and distributors of medical devices are regulated. Here, we’ll go over how to start preparing for an EU MDR audit. Keep reading for an EU MDR audit-readiness checklist.

Mandatory EU MDR Compliance Has Arrived

It’s a different world for Medtech companies. Most likely, you’ve already started developing and implementing your MDR strategy. Still, introducing new medical devices in the European market is now extraordinarily complex. As a medical equipment manufacturer or distributor, it’s vital that you understand and adapt to the new legislation. Here, we’ll provide you with a high-level checklist that touches on the top new MDR requirements. With our EU MDR audit checklist, you’ll have a better idea of whether your organization is checking off the right boxes.

Are You Ready for the Change?

Hopefully, you’ve already taken steps to accelerate your time to market for new devices. Within this plan should be the steps you’ll take to comply with MDR.

For example, you must classify your medical devices appropriately. You must also provide appropriate technical documentation. Furthermore, you must provide evidence of your compliance. Your compliance planning must also include a few key items, like:

  • Defective device liability
  • Post-market surveillance
  • Quality management

You must also set up key systems for managing clinical evaluations.

Certification Changes Have Arrived

The EU MDR has increased the workload of regulatory Notified Bodies (NBs). Regulatory clinical and certification activities will take longer. Now, companies must book in with a considerable list of NBs for certification. If you haven’t done so, it’s a good idea to get started on it right away. You also want to consider how you want to CE mark the products you plan to bring to market. You’ll have to choose between either the MDR or Medical Device Directive (MDD) standards.

Getting Audit-Ready

Moreover, you must prove that you’ve taken these steps. In other words, you must keep your organization in an audit-ready state.

Here, you must ask yourself a question, which is, “Do you have the capacity to stay audit-ready?” In this regard, you must review whether you have the staff and resources to meet this part of the new EU MDR regulation. You’ll need the staff and resources to stay prepared for increased:

  • Conformity assessments
  • Regulatory checks
  • Safety precautions
  • Tests

Also, the new MDR regulations require that all medical devices have a unique device identification (UDI) label. You must have a company team implement UDI tracking labeling according to MDR requirements. 

In addition, device users can file legal action for compensation caused by defective devices. Here, it’s important to review your agreements. You must make sure that you have measures in place for compensation if required. If you can’t maintain these responsibilities internally, it’s in the best interest of your firm to consider an alternative strategy. We can help. Trinity M Consulting,LLC. can help you stay aligned with new EU MDR regulations for less than it would cost for you to do so in-house.

What’s New With EU MDR Regs?

The new EU MDR regulations replace the 1999/43 ECE/CEE directive. This directive regulated the implementation of new medical technology in the European Union. Imagine that legislators once again issue a new MDR. Can your firm navigate another round of regulatory changes?

For now, all Class 1 reusable medical devices in use after May 25, 2020 must comply with the new regulations. For instance, they must have the numbers of Notified Bodies. This requirement can result in considerable delays in approval and inspection.

What to Expect

In many cases, it can take up to 16 weeks for CEPs to respond. However, Notified Bodies do offer additional services. These services may include an expedited review of EU MDR documents or technical information. The EU MDR has changed in several key areas. For example, legislators have enhanced the definition of medical devices. Now, medical devices include items such as colored contact lenses and cosmetic items. The list also includes devices designed to predict and diagnose various disorders and maladies.

Prepping for Compliance

Traditional harmonized standards aren’t necessarily the best way to prove MDR compliance. However, they are quite helpful. Still, they’re not mandatory if your organization uses another compliance method.

You don’t have to use harmonized standards to receive MDR approval. However, you do need harmonized standards to meet and maintain MDR requirements.

This checklist, will touch on the basic requirements needed to meet new EU MDR standards. It will help you to assemble technical documentation for EU MDR 2017/745 requirements. First, however, let’s look at a couple of changes that you may not have anticipated.

The New Operating Environment

The MDR creates deeper tracking mechanisms. These mechanisms enable manufacturers to trace products through the supply chain. Now, the European Databank on Medical Devices (Eudamed) will expand. This expansion will make it easier to access information about approved medical devices. So far, there’ve been no exceptions to new EU MDR rules. Unfortunately, there’s no “grandfathering” into the new requirements. All approved devices must undergo recertification and meet current standards.

The below checklist will point out items that are helpful to address regarding legal support and regulatory affairs. These checklist items are starting points for understanding the steps you’ll need to take to remain in EU MDR compliance.

EU MDR Checklist

It’s understandable to feel overwhelmed if you’re just beginning to work on EU MDR compliance. No matter the state of your organization, however, you’ll need to focus on the task at hand. When getting started on MDR compliance, it’s helpful to clear your mind of concerns and focus on the work before you. Below are some recommendations to consider:

  • Firstly, you’ll need to simplify your quality management system to speed up your remediation projects.
  • Next, you’ll want to increase your internal testing capabilities and make sure that your company is aligned with current medical product standards.
  • You must also develop an operational plan for all your GSP or flash audits. In other words, you’ll need a flash audit checklist for every CE-marked device. Now, you can develop a full MDR action plan.

The following are a few key items that you must include on your EU MDR audit checklist. For each item, you must assess whether your company is performing adequately or underperforming for each of your medical devices. If your organization is underperforming with a checklist item, you must develop an action plan to remedy the issue.

Risk Management Checklist Items

  • Develop a risk management plan for each device
  • Identify and evaluate foreseeable hazards
  • Estimate and evaluate risks during intended use and potential misuse
  • Eliminate or mitigate risks
  • Information from post-market surveillance system and production phase
  • If needed, amend quality control measures

Risk Mitigation Checklist Items

  • Provide safety information and training where appropriate
  • Perform a risk annex 16 evaluation for non-medical equipment

General Safety and Performance Requirements (GSPR) Checklist Items

  • Assess the compatibility of device components that contain more than one implantable part
  • Evaluate the impact of processes on material properties
  • Examine the mechanical properties of materials, such as strength, ductility, fracture resistance, resistance, and fatigue resistance
  • Evaluate the surface properties of materials
  • Confirm whether a device meets any defined chemical or physical specifications

Assess the risk related to the size and properties of particles that can be released into users’ bodies

Infection Control Checklist Items

  • Ensure safe cleaning, disinfection, or re-sterilization if needed
  • Make sure that devices requiring a specific microbial state remain in that state during storage and transportation

How Manufacturers Are Handling the Change

The EU MDR is the new minimum specifications for the safety and quality of medical equipment manufactured and introduced in Europe. The standard changed drastically in 2017. Now, the European Databank on Medical Devices will provide improved access. It’s important to understand how these changes will affect your organization. Hopefully, our checklist has provided you with meaningful insights.

Are You Ready?

Again, we ask, “Are you ready for the change?” Have you prioritized the steps you’ll take to prepare for EU MDR readiness?

Do you have a plan to succeed with your EU MDR implementation? Also, have you planned your workload effectively? The EU’s new medical device regulation is a mass of new requirements. Working toward EU MDR compliance without a plan can prove nightmarish. We do hope that our checklist provides some help in this regard. However, the truth is that every organization is different.

A checklist, in many instances, can prove superficial. In other words, you’ll most likely need an expert who can make a custom-crafted plan for your organization. Trinity M Consulting,LLC. can help you transition to the new EU MDR.

Partnering for Success With the New MDR

The introduction of new medical devices is a lengthy process. By partnering with us, you can save money and time. Furthermore, teaming up with the right consultant can mean the difference between success and failure.

We can help you bridge what might look like a massive chasm between design and commercialization. Furthermore, we can help you to avoid mistakes that will waste your organization’s time and resources. More importantly, we’ll provide you with the information you need to make the right decisions for introducing your new device to the EU market.

Benefits of Expert Consultancy

You may need help with communications and marketing. Alternatively, you may need assistance writing clinical trial protocols. You may even need help to scrutinize clinical trial data for the new EU MDR requirements. Trinity M Consulting,LLC. can point you in the right direction.

We’ll help you organize your submissions for regulatory authorization. We can also help you develop an effective quality management plan. We’ll provide you with the guidance you need to navigate the even more complex new regulatory compliance process.

How Can We Be of Service?

As you work to introduce a new product, you’ll most likely have plenty of questions because of the new EU MDR requirements. For example, you may now wonder if you’ve chosen the right regulatory pathway for approval. We can provide you with answers that correspond to the needs of your product. Our experts can also help you increase the quality of your project. We can also help you to execute your project in less time. Whether your organization is large or small, we can help you find answers. Most importantly, we’ll help you develop an actionable plan for success.

Taking the Next Step

At Trinity M Consulting,LLC. we want more than a one-off engagement. We work to build long-lasting relationships that result in a continuous series of successes over the years. We’re well versed in the intricacies of the new EU MDR audit readiness process. We can help you introduce your innovations to the European Union market successfully. With the changes brought to light by EU MDR, it makes sense to partner with an expert. Opportunities are fleeting. We can help you align your organization’s compliance initiative with quickly fleeting opportunities. Don’t struggle through EU MDR compliance. Trinity M Consulting,LLC. is here to help!

Connect With Us Today.

Again, we hope that the provided EU MDR audit readiness checklist has provided you with meaningful insights. If you need help with EU MDR compliance, contact us today to make sure that your organization can meet these complex new requirements.

 



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