Bringing a medical device to market is a complex and multifaceted process that requires careful planning, extensive documentation, and adherence to stringent regulatory standards. In this guide, we will break down the essential steps for obtaining CE or UK CA marking, discuss the importance of regulatory planning, and explore common challenges companies face during the process. Whether you are a startup or an established business, understanding these key milestones will ensure a smoother journey to market.

Regulatory Requirements: CE and UK CA Marks

The first critical step in getting a medical device to market in the EU or UK is securing the appropriate regulatory certification. For the EU, devices must be CE marked, while in the UK, a UK Conformity Assessed (UK CA) mark is now required. Although these two marks share similarities, they follow slightly different regulatory frameworks, which has created confusion as the UK transitions to its new system.

To achieve either mark, medical devices must comply with specific regulations. In the EU, the Medical Device Regulation (MDR) outlines these requirements, while the UK has its own evolving set of guidelines. Companies should monitor regulatory changes closely as the UK’s framework continues to develop. At present, navigating both sets of regulations is a challenge, and the process requires careful planning from the outset.

The Role of a Regulatory Strategy

A robust regulatory strategy is essential to successfully navigating the approval process. For businesses developing medical devices, especially for the first time, timing and planning are often underestimated. Many mistakenly believe that the pace of development dictates how quickly a device can be brought to market. However, the timeline for obtaining a CE or UK CA mark often hinges on the availability of a third-party body to review the device.

For most medical devices, approval requires assessment by a notified body (in the EU) or an approved body (in the UK). These bodies evaluate the company’s design, verification, and testing procedures to ensure compliance. With limited capacity at these bodies, companies frequently face bottlenecks, waiting months for assessments. This is especially true for devices classified above the basic Class I. For this reason, it is crucial to understand your device’s classification early in the process, as it directly impacts the timeline.

Building a Roadmap for Success

To avoid unnecessary delays, companies should develop a comprehensive roadmap for bringing their device to market. This roadmap must consider not only the regulatory timelines but also resource allocation, such as the financial and human resources required to achieve compliance. Two key areas of focus are regulatory approvals and quality management.

Implementing a Quality Management System (QMS)

A common pitfall for medical device startups is underestimating the importance of a quality management system (QMS). Some companies believe they can get by with a “light” version of a QMS until their operations scale. However, this approach is insufficient. A fully compliant QMS, based on ISO 13485 standards, must be implemented from the start. This system governs all business practices, from device development to post-market surveillance.

A QMS is not just about documentation; it is a fundamental framework that ensures the device’s safety, effectiveness, and reliability. It covers processes such as supplier selection, personnel recruitment, and how records are maintained. Importantly, companies need to demonstrate their compliance with the QMS to the notified or approved body during their application process. Therefore, building the QMS early and ensuring it aligns with ISO 13485 is critical.

Building a Team and Leveraging Expertise

Given the complexity of regulatory compliance, many companies will need to hire or consult external experts to guide them through the process. These consultants can help businesses navigate the requirements of ISO 13485, draft necessary documentation, and create objective evidence of compliance. This evidence includes everything from supplier certificates to employee qualifications, which must be available for review during the approval process.

By recruiting qualified individuals or partnering with experienced consultants, companies can build a QMS that meets regulatory standards from the outset. Furthermore, training internal staff on quality and regulatory requirements ensures that compliance becomes ingrained in the company’s culture and operations.

Key Pitfalls and How to Avoid Them

Even with a solid roadmap and QMS in place, medical device companies can still encounter challenges. Understanding and addressing these common pitfalls early can help avoid unnecessary setbacks.

1. Lack of Early Training on Regulatory Requirements

One of the biggest challenges startups face is failing to educate their teams on regulatory and quality requirements early in the development process. Ensuring that all team members are familiar with these standards will create a more cohesive approach to compliance. Training should cover the basics of ISO 13485 and relevant regulatory requirements, ensuring that everyone understands their responsibilities.

2. Delays Due to Regulatory Changes

The medical device regulatory landscape is constantly evolving, particularly with the introduction of the EU’s MDR and the UK’s ongoing regulatory revisions. Companies must allocate time to stay current with these changes. Monitoring guidance documents and updates from regulatory bodies ensures that businesses are prepared for shifts in compliance requirements, helping avoid costly delays.

3. Underestimating the Role of Quality and Regulatory Teams

In some organisations, quality assurance (QA) and regulatory affairs (RA) teams are viewed as separate from the core business. This mindset can lead to problems when compliance is seen as the responsibility of a few individuals rather than a company-wide priority. In reality, achieving regulatory approval and maintaining quality standards requires involvement from all departments. Everyone in the organisation should understand the importance of compliance to ensure the device is safe and meets regulatory standards.

4. Mismanagement of Resources

Bringing a medical device to market is resource-intensive. From the initial regulatory application to ongoing quality management, companies must allocate sufficient time, finances, and personnel. Startups, in particular, may struggle with resource limitations, so it’s essential to plan carefully and seek external support when necessary.

Navigating Regulatory Change and Guidance

With both the EU and UK undergoing significant regulatory changes, keeping up to date with evolving standards is more important than ever. All existing medical device standards are currently under review to ensure they align with the new regulations, and guidance documents are frequently released to clarify these changes.

While guidance documents are helpful, they can also be overwhelming due to the volume of information companies must absorb. Allocating time and resources for staff to read, understand, and apply these documents is crucial. In the coming years, both the MDR in the EU and the UK’s regulatory framework will continue to evolve, so companies must remain vigilant and adaptable.

Conclusion: A Company-Wide Approach to Compliance

In summary, bringing a medical device to market requires careful planning, comprehensive documentation, and a company-wide commitment to quality and regulatory compliance. From the initial regulatory strategy to implementing a robust QMS, each step is crucial in ensuring the device meets the necessary safety and performance standards.

Success in this highly regulated field hinges on early preparation, the right expertise, and a proactive approach to compliance. By addressing regulatory requirements, allocating resources effectively, and fostering a culture of quality, companies can navigate the complex journey to CE and UK CA marking with confidence.

The regulations are not just bureaucratic hurdles—they are vital for ensuring the safety of patients and end users. A commitment to compliance from the entire organisation will help deliver medical devices that not only meet regulatory requirements but also improve healthcare outcomes.

Watch the interview here:

Written by Educo Life Sciences Expert, Anne Jury

Anne Jury is a consultant and trainer in medical devices EU & UK regulatory compliance and quality assurance systems. Starting out as company microbiologist for Smith & Nephew Textiles Anne went on to work for Notified Bodies, BSI and then TÜV Product Service as a lead auditor and later as UK Regional Manager. Anne is also Vice-President of Team-PRRC, a non-profit organization set up in March 2020 to support individuals in the role of PRRC under the EU medical device regulations.

This article was written from a video interview conducted with Anne (you can watch it above).