Notified Bodies in Europe: Still Too Few to Meet the MDR/IVDR Challenge 

15 Jan 2026

Demand Surges, Capacity Stalls 

Implementing the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) has created a paradox: while regulatory rigor has increased, the institutional capacity to support it remains insufficient. Every medical device manufacturer must now undergo conformity assessment via a Notified Body (NB), yet the number of designated bodies is far too limited to meet demand. This imbalance threatens not only compliance timelines but also market access, innovation cycles, and patient safety across Europe. 

Since the full application of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), manufacturers must get certification from designated Notified Bodies (NBs) to access the European market. Yet, despite growing demand, the number of NBs remains critically low. This mismatch between regulatory obligation and institutional capacity poses systemic risks—delaying innovation, threatening supply continuity, and straining compliance teams across Europe. 

Regulatory Context: MDR, IVDR & the Role of NBs 

MDR (EU 2017/745), fully applicable since May 2021, and IVDR (EU 2017/746), applicable since 2022, replaced legacy directives with stricter requirements for clinical evidence, post-market surveillance, and documentation.  

Notified Bodies are independent organizations designated by EU Member States to carry out conformity assessments under the MDR and IVDR. They are the only entities allowed to conduct conformity assessments for medium- and high-risk devices. Their responsibilities include reviewing technical files, auditing quality systems, and issuing CE certificates. For many manufacturers, access to an NB has become the single most critical factor determining time to market and continued product availability. 

TSQ&E supports manufacturers in navigating NB selection, preparing compliant dossiers, and aligning with audit expectations—ensuring readiness across both the MDR and IVDR pathways. 

A system under pressure: key figures 

The scale of the challenge becomes clear when looking at the numbers. As of 2025, Europe has approximately 38,000 medical device companies and over 500,000 devices in circulation. A significant portion of these devices—around 80%—are still certified under legacy directives and must transition to MDR or IVDR.  

Only 51 NBs are designated under MDR and 19 under IVDR. Together, they are handling an estimated 28,500 certification applications., with just 43% resulting in certificates. Certification timelines average 13–18 months, and incomplete submissions further delay outcomes. Incomplete or insufficient submissions often extend these timelines even further, increasing pressure on both manufacturers and NBs.  

TSQ&E helps clients streamline documentation, reduce iteration cycles, and accelerate certification through precision and preparedness.  

Why NB Shortages Threaten Systemic Stability 

The shortage of NBs is more than a logistical bottleneck; it represents a systemic risk to the European medical device ecosystem.. Existing bodies are overwhelmed, and the complexity of MDR/IVDR increases the workload per application. Poorly prepared submissions compound delays, while looming deadlines raise the stakes. Without timely certification, devices risk being pulled from the market, leading to shortages and disrupted care.  

• Bottlenecks: NBs are overwhelmed; auditor capacity is limited 

• Regulatory complexity: MDR/IVDR demand deeper clinical evidence, post-market surveillance, and documentation 

• Poorly prepared applications: Delay both NB throughout and manufacturer timelines 

• Market access risks: Certification delays threaten device availability and patient access 

• Time pressure: With a final deadline of 2028, the transition window is rapidly closing 

TSQ&E offers readiness audits and strategic planning to help manufacturers mitigate these risks, maintain continuity and avoid costly delays.  

Looking ahead to 2028: will Capacity Catch-up? 

Projections suggest NB numbers could rise to 85 by 2027 and over 100 by 2028.These estimates depends on political will, national investment, and accreditation speed.  

Even under optimistic assumptions, demand is expected to remain high. By 2028, more than114,000 certification applications are expected, while forecasts show that around 95,000 certificates may be issued. This would leave each notified body responsible for an average of more than 900 certifications, a workload that raises questions about long-term sustainability and review quality. 

TSQ&E advises clients to plan for delays, diversify NB engagement, and build long-term certification strategies that expect capacity constraints. 

Implications for Manufacturers/Suppliers & PRRCs/QARA Teams 

For regulatory teams, the pressure is mounting. NB selection is now a strategic decision—based on availability, expertise, pricing, and device specialization. Proactive planning is essential: early file preparation, pre-assessments, and documentation quality can make or break timelines. Some manufacturers rely on foreign NBs, adding cost and complexity. Stable NB partnerships are critical for surveillance audits, renewals, and scope changes.  

TSQ&E helps build resilient regulatory roadmaps that anticipate bottlenecks and optimize NB engagement. 

What Can Be Done: System-Level Solutions 

Addressing the notified body shortage will require coordinated action at multiple levels. EU Member States can speed up designation processes, streamline evaluation requirements, and invest in auditor training to expand capacity. Clearer response timelines for NBs could also improve predictability for manufacturers. 

Manufacturers can contribute by improving the quality and completeness of submissions, reducing the need for multiple review cycles. Greater collaboration between notified bodies, competent authorities, and industry associations may help distribute workload more effectively and share best practices. 

We are here to help! 

The shortage of Notified Bodies highlights a critical tension in the European regulatory framework: increasing regulatory rigor without a proportional expansion of assessment capacity. Navigating this environment requires foresight, planning, and a realistic understanding of constraints. 

TS Quality & Engineering supports manufacturers throughout this transition by helping them strengthen technical documentation, prepare for NB audits, and build regulatory strategies aligned with MDR and IVDR realities. In a constrained system, preparedness and precision are key to achieving not only compliance, but continuity.