Laura Friedl-Hirst, managing direction at LFH Regulatory explores what regulatory intelligence is and how it can benefit businesses.
raker Shutterstock
With regulatory requirements ever evolving and the stringency of medical device regulation, it is no wonder that the complexities are confusing when it comes to regulatory compliance. But what do you understand when it comes to Regulatory Intelligence for medical devices and in vitro diagnostics (IVD’s)? For lower risk devices such as class I non-sterile, the regulatory intelligence should be pretty straight forward, but what about higher risk devices such as a class III implantable device with a software application? Using Regulatory Intelligence to implement your strategy can decrease time to market, reduce costs as well as ensure compliance.
As a medical consultancy we understand the challenges that organisations face in keeping up with all the various sources of regulatory intelligence. Factors such as the size of the business and resource will determine the commitments the regulatory professional will have, as well the availability they have to carry out Regulatory Intelligence activities. With advances in information technology there is an overload of information becoming readily available at an ever-increasing speed, from multiple different sources, making it difficult to keep up to date.
So, let’s delve a little more into regulatory intelligence and the benefits of building a robust process.
What Regulatory Intelligence is
To put it simply, it is defined as:
A systematic process of collecting, analysing, and disseminating information about regulatory requirements, policies, and guidelines that affect the development, manufacturing, distribution, surveillance, and regulation of medical devices.
The main stages of Regulatory Intelligence
- Gathering data: Information can be sourced from websites, blogs and professional newsletters, competitor and product analysis, regulatory e-mails, professional networking and guidance documentation. This list is not exhaustive and should be determined during planning.
- Process & analysis: Gathering data is the initial step, and so it becomes evident that this data needs to be filtered to obtain relevant information. The activity includes taking care of factors like the latest trends and patterns in the regulatory industry. This helps to understand the impact on current and future regulatory compliance.
- Regulatory strategy: The aim is to perform the above-mentioned to produce the most satisfactory and acceptable regulatory strategy for organisations. Devices may have specific regulatory guidelines in different countries.
- Dissemination: Sharing the analysed information with relevant stakeholders within the organisation to ensure everyone is informed about regulatory changes and their implications.
The purpose of Regulatory Intelligence
Regulatory intelligence is crucial to ensure that your medical devices are safe, effective and compliant with all relevant regulations. This not only protects manufacturers but also benefits patients by guaranteeing the highest standards of product quality.
Where Regulatory Intelligence comes from
Within the European Union, the EU Medical Device Regulation 2017/745 (MDR) & In Vitro Diagnostic Regulation 2017/746 (IVDR) states that manufacturers must stay up to date with regulatory changes and is embedded through both regulations. Although not referenced as regulatory intelligence, it is important to understand what you need to do. Both the MDR and IVDR document regulatory intelligence requirements as stated below:
Annex 1 – General Safety and Performance Requirements states that manufacturers must ensure devices meet safety and performance requirements throughout the lifecycle of the device necessitating regulatory intelligence. Essentially you will need to keep up to date with any changes, including any standards you are complying with.
Article 10 – General Obligations of manufacturers states that manufacturers are required to establish, document, implement, and maintain a system for risk management, which includes staying informed about regulatory updates.
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, documents the need for regulatory intelligence. This is implied and documented through the standard under several clauses:
- Clause 4.1.2(b) - General Requirements: Organisations are to identify applicable regulatory requirements and ensure they are incorporated into the QMS. This includes staying up to date with any regulatory changes.
- Clause 7.2.1 - Determination of Requirements Related to the Product: Organisations must determine and meet regulatory requirements related to their devices. To ensure compliance, regulatory intelligence activities are required.
- Clause 7.3.3 - Design and Development Inputs: The clause states that the design and development inputs must include applicable regulatory requirements and standards, which requires continuous monitoring of the regulatory landscape.
- Clause 8.2.1 - Feedback: Create a feedback system to collect data on product performance, ensuring it includes monitoring for regulatory compliance. This involves staying updated on any regulatory changes that could affect your device’s performance.
These clauses collectively underscore the importance of regulatory intelligence in maintaining compliance with EU Regulation as well as ISO 13485:2016.
The benefits of Regulatory Intelligence
Let’s dig a little further and explore several key areas where Regulatory Intelligence can benefit your organisation if you implement a robust process:
- Design & development: Regulatory intelligence can be used during the development phase of your device by identifying any potential regulatory requirements, including things such as clinical requirements, testing standards, etc. By doing this, you can prevent any future remediation activities, including expensive testing or clinical studies.
- Strategic planning: Regulatory intelligence supports strategic decision-making by providing a clear understanding of the regulatory landscape, which can influence product development, market access and business planning.
- Market access: Understanding and complying with regulations in the regions you wish to sell your device will facilitate faster market access and a smoother transition to launch.
- Compliance and safety: If you stay updated with the latest regulatory requirements, you can ensure your devices meet all necessary safety and quality standards. This assists in the prevention of adverse events, ensuring patient safety and avoiding costly recalls.
- Risk management: Understanding and keeping up to date with regulatory changes help in identifying and mitigating risks associated with potential non-compliance. Taking this proactive approach can save any business from potential legal and financial ramifications.
Conclusion
Regulatory intelligence is an indispensable tool for medical devices and in vitro diagnostic manufacturers. By systematically collecting, analysing, and disseminating regulatory information, manufacturers can ensure compliance, enhance product safety, and streamline market access.
The benefits of a robust regulatory intelligence process are manifold, including improved design and development, strategic planning, market access, compliance, safety, and risk management. As the regulatory landscape continues to evolve, staying informed and proactive is crucial for maintaining a competitive edge and ensuring the success of your medical devices in the global market. Embracing regulatory intelligence not only helps in meeting regulatory requirements but also fosters innovation and growth within the industry.