FDA - MDR: Transfer of the approval strategy to the US market

At medXteam, the focus is on clinical data. In this context, as CRO we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection. This time the topic in this context is the approval strategies on the US market. Regulatory requirements also apply here and clinical data is sometimes required. But this time the focus is on the question: How can I transfer my MDR approval strategy to the US market with the highest level of efficiency?

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

QMS quality management system

Underlying regulations

EU Regulation 2017/745 (MDR)
Medical Device Implementation Act (MPDG)
Federal Food, Drug and Cosmetic Act (FD&C Act)
Code of Federal Regulations (CFR), Title 21
Quality System Regulation (QSR) – 21 CFR Part 820
Medical Device Reporting (MDR) – 21 CFR Part 803
Unique Device Identification (UDI) – 21 CFR Part 830
Postmarket Surveillance – 21 CFR Part 822

1 Introduction

The global medical device market faces numerous regulatory challenges and requirements that vary across regions. Two of the most important regulatory frameworks are the European Union's Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA) approval processes. Both regulatory authorities have the primary goal of ensuring the safety and effectiveness of medical devices, but their requirements and processes differ significantly.

The MDR, which finally came into force in May 2021, replaced the previous Medical Device Directive (MDD) and brought with it significant changes and stricter requirements. It ensures that medical devices sold in the EU meet the highest safety and performance standards. The MDR requires comprehensive technical documentation, rigorous clinical assessments and continuous post-market surveillance. These stricter requirements pose a challenge for manufacturers who must ensure their products comply with the new regulations.

On the other side is the FDA, which plays a central role in regulating medical devices in the United States. The FDA classification of medical devices into different risk classes determines the approval process that a product must go through before it comes onto the market. The most common approval routes are the 510(k) Premarket Notification, the Premarket Approval (PMA), the Investigational Device Exemption (IDE) and the De Novo Classification. Each of these pathways has specific requirements for documentation and clinical data that must be submitted.

Transferring the MDR approval strategy to the US market is a complex process that requires careful planning and extensive knowledge of the regulatory requirements of both systems. Companies that want to successfully complete this transfer must understand the differences and similarities between the MDR and FDA regulations and adapt their documentation and processes accordingly. This includes identifying synergies, adapting technical documentation and reports, and taking specific FDA requirements into account in risk management and conformity assessment.

With this blog post we would like to create the basis and context for transferring the MDR approval strategy to the US market. We will examine the essential requirements and processes of the MDR and FDA, identify the main differences and similarities and discuss the specific challenges and solutions for the transfer process. The aim is to give companies practical insights and concrete recommendations for action in order to make the transfer process efficient and successful.

2. Medical device approval under the MDR

The MDR requires comprehensive technical documentation covering all aspects of the product life cycle, including design, manufacturing and clinical data. The process involves submitting this documentation to a Notified Body, which carries out a conformity assessment and, if successful, issues a CE marking. Medical devices that fall into class I under the MDR are excluded from the submission process.

Technical documentation under the MDR must contain detailed information about the medical device, including risk management reports, clinical assessments and evidence of compliance with all relevant standards. According to MDR, manufacturers must implement a robust risk management system that includes the identification, assessment and control of risks. Clinical evaluation is a continuous process that uses clinical data to confirm the safety and performance of the device throughout its life cycle. In addition, it is now mandatory for every manufacturer of a medical device to implement a complete quality management system with all relevant processes.

3. Medical device approval under FDA

The FDA categorizes medical devices into three classes (I, II, and III) based on their risk. Depending on the classification, manufacturers must submit either a 510(k) Premarket Notification, a PMA (Premarket Approval), or an IDE (Investigational Device Exemption). Each procedure has specific documentation and clinical data requirements.

The 510(k) Premarket Notification is intended for Class II products that must demonstrate that they are similar to a product already on the market. The PMA (Premarket Approval) is for Class III products that pose a higher risk and require evidence of extensive clinical data on safety and effectiveness.

The IDE (Investigational Device Exemption) makes it possible to carry out clinical studies with Class III products that have not yet been released on the market. The De Novo process provides a way to classify new products that do not have a similar approved product but pose a low to medium risk.

Even under the FDA, it is essential for manufacturers to implement a robust quality management system in accordance with the requirements (21 CFR Part 820) to ensure the quality and consistency of the products.

4. Comparison of the approval processes: MDR vs. FDA

Both systems have the common goal of ensuring the safety of medical devices, but differ in their approaches. The MDR requires strict post-marketing surveillance and ongoing clinical evaluations for each type of medical device, while the FDA offers different approval pathways based on the risk of the product.

MDR approval can be time-consuming and costly as extensive clinical data and detailed technical documentation are required depending on the type and risk class of the product. FDA approval can vary depending on the process (510(k), PMA), with PMA (Premarket Approval) processes typically being more expensive and lengthy than 510(k) submissions.

The MDR requires extensive technical documentation and ongoing clinical assessments. The FDA also requires detailed documentation, but specific requirements may vary depending on the approval route and product classification. Clinical trials are often necessary for PMA (Premarket Approval) and IDE (Investigational Device Exemption), while 510(k) relies on existing clinical data.

5. Transfer of the MDR approval strategy to the US market

When transferring the MDR approval strategy to the US market, much of the data and documentation that has already been collected can be reused. However, it is important to recognize the differences in regulatory requirements and make adjustments accordingly. The technical documentation prepared for the MDR may need to be adjusted to meet FDA's specific requirements. This may include reformatting reports, additional testing, or creating new documents required by the FDA.

The existing ISO 14971 risk management system can be retained in many aspects, but may need to be expanded to meet specific FDA requirements. The conformity assessment must comply with the FDA regulatory framework.

6. Challenges and Opportunities

Typical challenges include differences in regulatory requirements, additional documentation requirements, and the need for additional clinical data. These issues can lead to delays and increased costs.

Successful strategies include planning the transfer process early, working closely with regulatory experts, and carefully adapting existing documentation to FDA requirements. Constant monitoring of regulatory updates and changes is essential as these can impact approval requirements and processes. Companies should remain flexible and adapt their strategies accordingly.

7. Conclusion and conclusion

Transferring the approval strategy from the European Medical Device Regulation (MDR) to the requirements of the US Food and Drug Administration (FDA) is a complex but feasible process. Both regulatory systems have the same goal of ensuring the safety and effectiveness of medical devices, but they differ in their specific requirements, processes and documentation requirements. The success of such a transfer depends on a thorough analysis of the differences and similarities between MDR and FDA, as well as careful adaptation of existing documentation and processes.

An important aspect of the transfer is the identification of synergies where existing data and reports from the MDR process can be used to meet FDA requirements. At the same time, manufacturers must consider FDA's specific requirements, including adapting risk management, clinical evaluations and technical documentation. Implementing a robust quality management system in accordance with 21 CFR Part 820 and complying with Unique Device Identification (UDI) requirements are additional critical elements that must be considered.

Manufacturers going this route should consider the following key strategies:

• Early planning and analysis of differences and similarities
• Use synergies of existing data and documentation
• Make specific adjustments to the technical documentation (e.g. risk management)
• Review the quality management system with regard to FDA requirements (21 CFR Part 820).

Transferring the approval strategy from the MDR to the US market presents a challenge, but also offers the opportunity to expand market access in the US and promote global growth. With a careful and well-planned strategy, manufacturers can successfully navigate this process

8. How we can help you

We would be happy to support you with a successful and efficient transfer of your MDR approval to the US market. The first step is to decide on an approval process that is suitable under the FDA. We will then work with you to develop strategies with which you can get the most out of your existing documentation and existing clinical data in order to adapt them to the regulatory requirements on the US market in a cost- and time-efficient manner.

We support you throughout your entire project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation through to technical documentation - always with primary reference to the clinical data on the product: from the beginning to the end End.

Do you already have some initial questions?

You can get a free initial consultation here: free initial consultation