Building a Successful Regulatory Strategy to Ensure Compliance

By Annemien Pullen, VP, MedTech Cloud

At the recent Veeva MedTech Summit in Munich, two industry thought leaders shared their best practices for building a regulatory strategy that spans multiple teams. This is a critical plan because it outlines not only the regulatory requirements for bringing a new product to market but also how to sustain it for the duration of the product lifecycle. Therefore, it’s necessary to establish your regulatory strategy in the early phases of product development.

Dr. Fatima Bennai-Sanfourche, the senior director of QA & RA compliance for medical devices and eHealth at Bayer AG, explained that when developing a regulatory strategy, it’s important to understand several key aspects:

1. Device qualification – different countries may have different definitions for what’s considered a medical device
2. Device classification – will determine the risk level of your device
3. Required documentation – depends on the markets you are entering
4. Intended purpose of the device – why you’re developing the product, for which population, and in what environment
5. Compliance requirements – vary based on the countries you are targeting
6. Legal manufacturer location/compliance ownership – may require authorized representatives by location.
7. Target markets – will affect supply chain and distribution considerations

However, it’s not as simple as just writing down these answers. An effective regulatory strategy is a living document that requires proactive planning, cross-functional collaboration, and adaptability. Engaging stakeholders early in the process, from development to regulatory affairs to marketing and quality, is essential to align efforts and mitigate potential roadblocks.

Fatima further shared that the MDR/IVDR introduced a new QMS requirement called a “strategy for regulatory compliance”. This is intended to provide a high-level summary of the implemented regulatory compliance efforts for a device/device family in Europe and other major markets, and it needs to be maintained over the lifecycle of the product. As Fatima described, “Regulatory compliance is a shared responsibility across the entire supply chain, including economic operators. Collaboration and clear communication are key to ensuring compliance.”

Dr. Bassil Akra, the CEO and owner of AKRA TEAM GmbH, also expressed the importance of coordinating efforts across the organization, including with management. “You need from top down to give the right direction and ensure that everyone understands that we are fighting for the same target”, said Akra. Establishing KPIs that tie back to the bigger picture will also help business units stay on the same page.

When asked about the role of technology in regulatory strategy, both Fatima and Bassil spoke about the significance of a single source of truth for documents and data. This not only improves collaboration, but also facilitates communication and training when it comes to adopting new processes. However, technology alone will not ensure compliance. Bassil emphasized, “A lot of people mix up technology with the work that they have to do by themself”. Regulations will continue to evolve, and organizations must adapt their regulatory strategy to be successful. Fatima summarized, “You are responsible for product safety and quality, you need to have quality oversight, compliance oversight, and you need to make sure that the work is done, and technology can support you with that.”

To learn more about ways to bolster your company’s regulatory strategy, watch this session on implementing regulatory intelligence programs delivered by Siemens Healthineers at the Veeva MedTech Summit.