Regulatory and Standard Monitoring: Staying the Course Towards Compliance

Whether in the life cycle of a medical device (MD) or an in vitro diagnostic medical device (IVDMD), it is not uncommon to face unforeseen circumstances, such as modifications that need to be implemented after obtaining CE marking or due to constantly evolving regulations. For MD and IVDMD manufacturers, these events constitute a major challenge for maintaining compliance.

This is where regulatory and standard monitoring comes into play. Just like the devices themselves, regulations are constantly evolving, requiring continuous monitoring to avoid discrepancies or deviations and maintain compliance.

What is regulatory monitoring? 

Regulatory and standards monitoring for MDs and IVDMDs is a systematic process of tracking, analyzing, and applying the legal, regulatory, and standards requirements that govern the design, manufacture, marketing, and post-market surveillance of health products until their end-of-life.

Why is it necessary?

Ensuring Compliance: The Key Role of Monitoring

In a context where legal, regulatory, and standard requirements are of crucial importance in guaranteeing device performance and safety,, Regulations (EU) 2017/745 and 2017/746 have accentuated this necessity. Device manufacturers are thus required to establish a rigorous regulatory monitoring process, as demanded by Article 10 of the MD and IVDMD Regulations, as well as by the EN ISO 13485:2016 standard.

The goal of this regulatory monitoring is twofold: on the one hand, to ensure that the benefit/risk ratio remains positive for devices already on the market, and on the other hand, to enable manufacturers to take proactive measures to effectively respond to new requirements that may be identified over time.

More specifically, the importance of continuous monitoring lies in several crucial aspects:

1. Compliance: Regulations such as the Regulations (EU) 2017/745 and 2017/746, 21 CFR part 820, and other international regulations impose strict requirements that manufacturers must adhere to in order to market their products. Regulatory monitoring allows manufacturers to stay informed of the latest updates and avoid recalls, product withdrawals, and penalties.
2. Market Access: A good understanding of current regulations is essential for entering new markets and maintaining a presence in existing ones. Requirements can vary significantly from one region to another, and effective monitoring helps to navigate these differences.
3. Patient Safety: Medical devices must be safe and effective. Regulations are developed and adopted to protect public health. By keeping up with regulatory changes, manufacturers must ensure that their products meet current safety standards and the state of the art, ensuring a favorable benefit/risk ratio.
4. Anticipation – “Innovation”: Monitoring allows for the detection of regulatory trends, enabling manufacturers to anticipate changes and innovate accordingly.
5. Risk Management: By identifying regulatory developments, manufacturers must take steps to manage associated risks (including legal, financial, etc.).

Well-orchestrated regulatory and standards monitoring, appropriate to manufacturers’ given sector of activity, thus constitutes a major strategic asset for maintaining compliance and the quality of products on the market.

Challenges for Manufacturers

The main obstacles related to regulatory and standards monitoring for MD and IVDMD manufacturers are:

• Costs: The costs associated with acquiring IT tools, accessing certain sources, and subscribing to specialized databases for regulatory and standards monitoring are significant, especially for small companies;
• Required regulatory expertise: The interpretation of regulatory texts, their understanding, and the application of requirements, or even translating the requirements into the company’s processes, require specific expertise. The need to continuously monitor regulatory and normative developments can represent a significant workload for staff;
• Time to Market: Companies operating internationally must comply with a multitude of regulations and standards specific to each country or region, which further complicates regulatory and standards monitoring; 
• Complexity: Given the abundance of regulatory and normative changes and updates, it is difficult to stay up-to-date, and this can require continuous efforts to understand and correctly interpret new requirements.

In summary, regulatory and standards monitoring is an indispensable tool for anticipating, tracking, and updating devices, technical documentation, and company processes, regardless of the target market. By mastering these challenges, manufacturers can turn them into a controlled opportunity for their business.

How to set up an effective regulatory monitoring system? 

The steps and best practices for establishing regulatory monitoring can be based on an effective PDCA cycle:

You don’t have the resources or skills to implement effective and compliant monitoring within your company? Efor is here to support you!

Efor group can support with your regulatory watch, from setting up the process to carrying out the monitoring for you, and enabling you to remain compliant. Our regulatory affairs experts offer support tailored to your needs:

• Annual monitoring in the form of a quarterly bulletin
• Implementation of Quality Management System (QMS) documentation related to this process 
• Conducting a GAP analysis of the developments and new findings in relation to your QMS, documentation, etc. 
• Planning and implementing improvement actions to meet the newly identified requirements 
• Training on new regulations and requirements 
• Auditing to assess the effectiveness of corrective and preventive actions

Our technical management teams are available to assist you in your projects and can be contacted at onedt@efor-group.fr.