Notified Body

‍A Notified Body is specific to the European regulatory environment, particularly for medical devices, and is a mandated, independent third-party assessment required for market access.

A Notified Body is an EU-authorised organisation responsible for independently evaluating whether a manufacturer's medical device and its underlying quality management system (QMS) meet the stringent safety and performance requirements set out in European Union regulations, such as the Medical Device Regulation (MDR).

Their primary role is to serve as the regulatory gatekeeper, performing the mandatory conformity assessment required for a device to receive the CE mark and enter the EU market.

The function of a Notified Body is crucial for medical device manufacturers seeking market approval in the European Union (EU) and European Economic Area (EEA).

Mandatory Role in Device Certification

The level of involvement required by a Notified Body depends entirely on the device's classification under the EU MDR:

• Required Involvement: Only Class I medical devices (those that are non-sterile, non-surgical, and without a measuring function) can avoid Notified Body involvement.
• Mandatory Involvement: For all other higher-risk devices, including Class IIa, Class IIb, Class III, and some specific Class I devices, manufacturers must select and engage with a Notified Body to begin the conformity assessment process.
• Purpose: The Notified Body is responsible for performing conformity assessments and issuing CE certificates under MDR. They remain actively involved throughout the product lifecycle.

The Assessment and Audit Process

Obtaining certification through a Notified Body involves rigorous scrutiny of the manufacturer’s systems and products:

• Audits: The Notified Body conducts audits, which typically include both a readiness audit and a full MDR compliance audit.
• Certification Status: The MDR treats certification as a new market entry, even for devices that have been on the market for years under previous regulations (like the MDD).
• Documentation Review: The Notified Body assesses whether the device meets MDR standards and reviews the manufacturer's systems, including checking for established, robust Corrective and Preventive Action (CAPA) systems to address product issues.
• Outcome: If the device successfully passes the audits, the manufacturer can then sign the Declaration of Conformity, marking the official MDR market entry.

Impact on the Industry and Supply Chain

The engagement and capacity of Notified Bodies are significant operational factors for medical device manufacturers:

• Current Challenges: The ongoing MDD to MDR transition process has been affected by Notified Body backlogs and capacity limitations, leading to potential delays in final certification for manufacturers. Manufacturers must stay flexible and responsive to Notified Body feedback to ensure compliance.
• Supplier Accountability: A supplier who provides products or services to a manufacturer (Purchaser) who is accountable to an NB must grant ISO Notified Bodies access to audit the supplier’s facility and records if required.
• Ongoing Compliance: Manufacturers must work closely with their Notified Bodies to finalize MDR certification, maintain updated technical files, and ensure compliance with post-market surveillance requirements.

Analogy for Understanding

A Notified Body acts like a highly specialized, licensed building inspector in the European Union. You can’t legally sell a high-rise building (a medium-to-high-risk medical device) in the EU just because you say it’s safe. The Notified Body steps in to review every blueprint (technical documentation), audit every construction step (QMS/CAPA audits), and confirm the safety features, waste systems, and materials comply exactly with all local codes (MDR requirements). Only when the Notified Body signs off, giving the certification, can you open the building for use.

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