The EU’s Innovation Focus: A Five-Year Outlook from a Notified Body Perspective

Introduction

Over the past five years, the European Union (EU) has sharpened its regulatory approach to foster medical devices’ innovation while maintaining its foundational commitment to public safety, quality, and performance. In doing so, it has introduced a more rigorous and structured regulatory environment across sectors such as medical devices, in vitro diagnostics, and artificial intelligence (AI). 

As a leading Notified Body, BSI has engaged closely with manufacturers, regulators, and other stakeholders throughout this period. This article offers a perspective on how the EU’s focus on innovation is unfolding in practice, highlighting the challenges, achievements, and opportunities observed through our Notified Body role. 

Regulatory Evolution and Its Implications for Innovation 

Strengthening the framework

The implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) marked a transformative shift in EU regulatory policy. These regulations raised the bar for clinical evidence, technical documentation, and post-market surveillance, to ensure product safety and performance while increasing transparency and traceability. 

The adoption of the Artificial Intelligence Act establishes a framework for high-risk AI systems, many of which will require third-party conformity assessment by designated Notified Bodies. The AI Act reinforces the EU’s commitment to responsible innovation, data governance, and fundamental rights. 

Innovation-enabled, risk-based approaches

To support innovation, the EU has encouraged more flexible regulatory mechanisms, including: 

• Early engagement mechanisms with Notified Bodies, EU Expert Panels.  

• Development of special pathways for breakthrough or orphan technologies. 

• Consideration of adaptive evidence requirements where appropriate, particularly in cases of unmet clinical need or rapid technological advancement with issuance of certificates with conditions.  

At BSI, we have observed increased demand for structured pre-submission dialogue, particularly for startups or novel products that do not align neatly with existing device classifications or standards. 

The expanding role of Notified Bodies

Notified Bodies are integral to the innovation ecosystem in Europe. Over the last five years, our role has evolved beyond traditional conformity assessment to encompass earlier discussions and capacity-building functions. 

Increased expectations and expertise requirements

Under MDR and IVDR, Notified Bodies must demonstrate technical and in-house clinical competence across a wide range of disciplines, including: 

• Clinical evaluation and performance assessment. 

• Software and digital health, including AI. 

• Cybersecurity and data protection. 

• Combination products and borderline classifications. 

This expansion of scope has placed additional pressure on NB resources, with the increased complexity and volume of technical assessments requiring significant investment in people, systems, and infrastructure. 

Contributing to regulatory predictability

One of the key challenges faced by manufacturers is the variability in interpretation of regulatory requirements across different NBs. BSI is committed to ensuring consistency, objectivity, and clarity in our assessment processes, while actively contributing to the harmonisation of practices across Europe through participation in MDCG working groups and sector-specific coordination platforms. 

Innovation Challenges Through the NB Lens 

Despite progress, several ongoing challenges risk impacting the EU’s ability to deliver on its innovation goals. From a Notified Body perspective, these include: 

1. Bottlenecks and market access constraints

Capacity limitations across the NB system have led to longer lead times for conformity assessments, particularly for new devices, legacy product renewals, and SMEs/startups unfamiliar with the new regulatory landscape. This is most pronounced in high-risk classifications and complex technologies. BSI was the first Notified Body to publish its capacity and conformity assessment lead times for Medical Devices and IVDs. 

2. Novel technologies requiring novel approaches

Many of the most promising innovations, such as AI-based decision support tools, adaptive software, and personalised medicine, do not fit traditional device paradigms. These require flexible but robust evaluation frameworks, and close collaboration between innovators and NBs to ensure safety is not compromised in pursuit of novelty. 

3. Evolving regulatory guidance

While the European Commission and MDCG have issued a growing body of guidance documents, gaps remain in key areas such as: 

• Clinical evidence requirements for novel technologies. 

• Qualification criteria for AI as a medical device. 

• Application of general safety and performance requirements (GSPRs) to software and digital platforms. 

These uncertainties can delay development or lead to inconsistencies in market access decisions across the EU. 

EU Efforts to Support Innovation Responsibly 

The EU has taken several constructive steps to help mitigate regulatory friction while supporting its long-term innovation goals. 

Capacity building and system strengthening 

Initiatives such as NoBoCap aim to expand NB capacity through training, knowledge-sharing, and process optimisation. BSI supports these efforts and is investing heavily in staff development and digital infrastructure to meet rising demand. 

Transitional provisions and implementation flexibility 

Recognising the challenges of full MDR/IVDR implementation, the EU has extended transitional deadlines for certain products and provided guidance on legacy device management. These measures help avoid market disruption while enabling stakeholders to adapt to the new framework. 

Enhancing regulatory guidance 

The EU’s ongoing development of MDCG guidance on subjects ranging from classification to post-market surveillance supports more consistent application of the regulations. BSI actively contributes to these discussions to ensure guidance is practical, risk-proportionate, and future-ready. 

The Role of Notified Bodies in Supporting Innovation 

While challenges persist, there are significant opportunities for NBs to contribute positively to innovation in Europe. 

Enabling early dialogue 

Structured Dialogue services can help manufacturers identify potential regulatory pitfalls early and develop robust evidence generation strategies. BSI has offered Structured Dialogue for 20 years to help innovators align with regulatory expectations from the outset. 

Supporting SMEs and Start-ups 

Smaller organisations may lack dedicated regulatory expertise. Notified Bodies can play a critical role by providing clear requirements and educational resources on assessments that support innovation without compromising safety. Globally, more than 86% of manufacturers BSI works with across all regulatory certification services are SMEs of which 11% are startups. 

Advancing regulatory science 

BSI collaborates with academic institutions, innovation hubs, standards bodies, and regulators to help shape future-ready regulatory approaches. Our work in AI, digital health, and combination products reflects our commitment to advancing regulatory science in line with emerging technologies. 

Recommendations for an Innovation-Ready NB Ecosystem 

To further strengthen the EU’s regulatory framework and support its innovation agenda, we recommend the following: 

1. Formalise innovation pathways

The EU should establish structured innovation pathways with clearly defined criteria, timelines, and expectations. 

2. Promote harmonisation

Greater harmonisation across NBs through shared assessment criteria, coordinated interpretations, and transparent decision-making, would enhance predictability and fairness for manufacturers. 

3. Build regulatory capacity

Continued investment in NB staff training, digital tools, and collaborative networks is essential to manage the increasing complexity and volume of conformity assessments. 

4. Support proactive engagement

Regulators, expert panels, and NBs should encourage early dialogue, joint planning, and scientific advice to facilitate faster and more effective regulatory pathways. 

5. Embrace digital transformation

As both products and regulatory systems become more digital, investment in data-driven tools (e.g., eIFUs, UDI systems, real-world evidence platforms) will be key to improving both compliance and efficiency. 

What Lies Ahead for Innovation in Europe? 

Over the past five years, the European Union has made significant strides in aligning regulatory rigor with innovation goals. As a Notified Body, BSI sees clear progress – both in the maturity of the regulatory framework and in the increasing quality of engagement from manufacturers. 

However, to fully realise the EU’s ambition of becoming a global leader in safe, responsible innovation, continued focus is needed on capacity building, harmonisation, and regulatory adaptability. Notified Bodies are essential enablers of innovation. By working together, we can ensure the EU remains both a trusted and forward-looking environment for the technologies of tomorrow. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.