EU Commission to Harmonize Notified Body Procedures: Predictability in Sight

Manufacturers of medical devices (MDR 2017/745) and In Vitro Diagnostics (IVDR 2017/746) have long struggled with the unpredictable nature of conformity assessments. These delays do not just affect business cycles; they have direct repercussions on patient health across the European Union.

To resolve this, the EU Commission is working on a new Implementing Regulation designed to lay down uniform quality management and procedural requirements for Notified Bodies (NB).

Addressing the Divergence in Timelines and Costs

Currently, there is a significant lack of transparency regarding how Notified Bodies establish their schedules and fees. The most striking issues include:

• Inconsistent Timelines: No clear rationale exists for how review durations are determined, making it impossible for manufacturers to predict when a product will reach the market.
• Cost Variability: Prices for quotations and overall services vary wildly between different NBs, often without a clear breakdown of fees.
• Information Gaps: Manufacturers lack reliable data to estimate the total investment required for certification cycles.

Key Changes Under the New Regulation

The upcoming implementation law seeks to build trust and efficiency through several core requirements:

1. Published Timelines: NBs will be required to publish clear timelines for initial assessments and change control requests.
2. Defined 'Clock Stoppers': The regulation will implement clear rules on time control stoppers, ensuring manufacturers know exactly when the review clock is paused and why.
3. Structured Certification Phases: Standardized procedures for the certification and re-certification process to ensure uniformity across the EU.
4. Transparent Cost Breakdowns: Costs must be clearly presented with a detailed breakdown. Crucially, this may include estimated costs for surveillance activities required throughout the entire certification cycle.

Looking Ahead

While the industry awaits the final publication, translation, and release of this law, the signal is clear: the EU is moving toward a more predictable and efficient regulatory environment. For manufacturers, this means better project planning, more stable budgeting, and ultimately, a faster path to delivering life-saving technologies to patients.

Stay tuned for the final release of this implementation law to begin adjusting your regulatory strategy accordingly.