What does a Notified Body do?
In the context of MDR and IVDR, Notified Bodies are responsible for verifying the compliance of medical devices and in vitro diagnostic devices with the relevant safety, effectiveness, and quality standards. They conduct audits of quality management systems in accordance with the ISO 13485 standard, assess technical documentation, and analyze clinical data provided by manufacturers. Notified Bodies are also responsible for issuing certificates of conformity, allowing manufacturers to place the CE mark on products and legally introduce them to the EU market.
According to Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017, on medical devices (MDR), the involvement of a Notified Body in the conformity assessment process is required in the following situations:
- For Class I medical devices that are supplied in a sterile state, have a measuring function, or are reusable and require re-sterilization, the involvement of a Notified Body in the conformity assessment process is mandatory.
- For Class IIa, IIb, and III medical devices, the involvement of a Notified Body is mandatory, regardless of their specific characteristics.
- If a medical device contains a substance that, when used separately, could be considered a medicinal product, an evaluation by a Notified Body is required.
- In the case of devices containing derivatives of tissues or cells, the involvement of a Notified Body is required due to the specific risks associated with such components.
- The manufacturer of a system or procedure pack that sterilizes the system or pack or conducts its conformity assessment must engage a Notified Body in the conformity assessment process.
In other cases, such as Class I medical devices without a measuring function, not intended for sterilization or reuse requiring re-sterilization, the manufacturer may conduct the conformity assessment procedure independently and issue the EU Declaration of Conformity without the involvement of a Notified Body.
What are the main tasks of a Notified Body?
The main tasks of a Notified Body are:
- Product Conformity Assessment
The Notified Body checks whether the product meets the requirements outlined in EU regulations, such as Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR). It evaluates the technical documentation, functionality, and safety of the product.
- Conducting Audits
Audits are conducted to check if production processes comply with the requirements and ensure the consistent quality of the product.
- Testing and Product Examination
Specialist tests are conducted in laboratories to confirm that the product functions as intended and is safe for the user. The Notified Body analyzes clinical data to confirm the safety and effectiveness of the device.
- Issuing Conformity Certificates
After the positive conformity assessment, the Notified Body issues a conformity certificate that allows the manufacturer to place the CE mark on the device.
- Post-Market Surveillance (PMS)
The Notified Body monitors products after they have been placed on the market to ensure they meet the requirements throughout their usage. It also analyzes incident reports and conducts special audits when necessary.
Legal Basis for the Operation of Notified Bodies
Notified Bodies in the medical device and in vitro diagnostic device (IVD) sector operate based on clearly defined EU legal regulations that define their role, duties, and requirements for their functioning. The key regulations are two EU regulations: Regulation (EU) 2017/745 on medical devices (MDR – Medical Devices Regulation) and Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR – In Vitro Diagnostic Regulation). These documents establish detailed rules for conformity assessment of devices by Notified Bodies, including requirements for their qualifications, independence, resources, and certification procedures.
The functioning of Notified Bodies is also based on Regulation (EC) No. 765/2008, which defines the general principles of accreditation and market supervision of products in the EU. The Decision of the European Parliament and Council No. 768/2008/EC introduces common legal frameworks for the product conformity assessment system, defining the tasks and duties of Notified Bodies and their relationship with manufacturers. These documents ensure a uniform regulatory system across the European Union, allowing the free movement of certified goods on the common market.
Role of Notified Bodies in the Conformity Assessment Process of Medical Devices
A Notified Body plays a key role as an independent assessing body, whose task is to verify the conformity of a medical device with the requirements of Regulation (EU) 2017/745 and 2017/746.
- Independent Conformity Verification
The Notified Body conducts an independent evaluation to check if the device meets the essential requirements of the MDR, including patient safety, clinical effectiveness, and risk management. The Notified Body acts as an external auditor, objectively assessing the conformity of the device with legal and technical regulations.
- Technical Documentation Assessment
As part of its role, the Notified Body reviews the device’s technical documentation, verifying whether the manufacturer has appropriately demonstrated conformity with the MDR requirements. This review covers aspects such as the intended use of the device, risk-benefit analysis, clinical properties, and data confirming the safety and effectiveness of the device.
- Certification
The Notified Body is responsible for issuing the conformity certificate, which authorizes the manufacturer to place the CE mark on the medical device. This certificate is formal confirmation that the device meets all regulatory requirements and can be placed on the European market.
- Supporting Regulatory Compliance
The Notified Body also plays an advisory role regarding the interpretation of MDR regulations, helping manufacturers align their processes with legal requirements. It assists in understanding complex regulatory requirements and adjusting documentation and quality processes accordingly.
- Post-Certification Conformity Monitoring
After issuing the certificate, the Notified Body monitors the ongoing compliance of the device through periodic audits and inspections to ensure the device continues to meet regulatory requirements.
Notified Body and Post-Market Surveillance (PMS)
After certification, the Notified Body performs regular surveillance of the product and manufacturer through the following actions:
1. Surveillance Audits of Quality Management System (ISO 13485)
The Notified Body conducts periodic audits at the manufacturer’s site to verify if the quality management system continues to meet the requirements of the ISO 13485 standard and MDR/IVDR regulations.
2. Monitoring Post-Market Surveillance (PMS)
The Notified Body evaluates how the manufacturer fulfills the post-market surveillance obligations regarding the product on the market, including:
- Collecting data about the device’s performance,
- Analyzing incident and complaint reports,
- Assessing corrective actions and product modifications,
- Reviewing periodic safety update reports (PSUR) which are mandatory for Class IIa, IIb, and III devices.
3. Incident Evaluation and Corrective Actions (FSCA – Field Safety Corrective Action)
- In the case of severe incidents (e.g., health risks to patients), the Notified Body monitors actions taken by the manufacturer, such as recalling the device from the market or modifying it.
- The manufacturer is obliged to report incidents to the Notified Body and regulatory authorities, e.g., to the national Office for Medicinal Products Registration (URPL).
4. Review of Changes in the Device and Production Process
The manufacturer must report any significant changes to the Notified Body regarding:
- Device design,
- Production process,
- Suppliers of key components,
- Device controlling software.
The Notified Body analyzes the impact of these changes on device conformity and, if necessary, conducts additional audits or tests.
5. Unannounced Audits
According to MDR, Notified Bodies have the right to conduct unannounced audits to check whether the manufacturing process complies with requirements.
6. Compliance with Advertising and Labeling Requirements
The Notified Body checks whether the manufacturer misleads users about the intended use and functionality of the device through incorrect advertising materials or non-compliant CE labeling.
Collaboration with a Notified Body
To ensure a smooth certification process, the manufacturer must prepare:
- Complete technical documentation in accordance with the requirements of MDR or IVDR, including:
- Product description and intended use,
- Risk and benefit analysis,
- Clinical data (MDR) or validation results (IVDR),
- Instructions for users (e.g., user manuals).
A quality management system in accordance with the ISO 13485 standard, ensuring appropriate production processes and supervision over the devices.
After selecting a Notified Body, the manufacturer should sign a cooperation agreement, specifying the scope of conformity assessment, the duties of both parties, and the schedule. The manufacturer is also obliged to provide the Notified Body with access to the production facility and documentation during audits and inspections.
Collaboration with a Notified Body does not end after obtaining the certificate. The manufacturer must undergo periodic audits conducted by the Notified Body to confirm that the quality management system and production processes still meet the requirements. The manufacturer is also obliged to inform the Notified Body of any significant changes to the device that could affect its conformity (e.g., material changes, production methods).
The manufacturer must carry out post-market surveillance (PMS) of the device after it is placed on the market, and the Notified Body monitors compliance with these activities in line with MDR/IVDR requirements. This includes collecting and analyzing data regarding the safety and performance of the device in practice, as well as reporting serious incidents and corrective actions.
How Pure Clinical Can Help with the Selection of a Notified Body?
Pure Clinical can assist manufacturers in:
- Identifying suitable Notified Bodies,
- Assessing the competence of Notified Bodies,
- Comparing service costs offered by different Notified Bodies,
- Preparing technical documentation and quality management systems to meet the requirements,
- Supporting manufacturers in case of discrepancies or questions from the Notified Body.
Our support allows for efficient and regulatory-compliant assistance in choosing and collaborating with Notified Bodies.
FAQ
Does every company have to cooperate with a Notified Body?
What are the consequences of choosing the wrong Notified Body?