Understanding the Role of Notified Bodies in MDR Compliance

Similar to the role of Economic Operators, it is important to recognize that Regulation (EU) 2017/745 (MDR) includes a full chapter (Chapter IV) dedicated to Notified Bodies. 

Notified Bodies are responsible for ensuring that medical devices comply with the MDR. Chapter IV under the MDR outlines various requirements and guidelines, including a reference to Annex VII, “Requirements to be met by Notified Bodies.”  

While Annex VII is critical for Notified Bodies, it is equally important for manufacturers to be familiar with it. This article will focus on key aspects of Annex VII, which are just as important for Medical Device Manufacturers to review as any other section of the MDR. 

To learn more about MedEnvoy’s EU IVDR/MDR Compliance Strategy, click here.

Notified Body vs Manufacturer Requirements Under the MDR 

While manufacturers are managing the design and development of their medical devices, it is more than likely they will oversee the perspective of a Notified Body. 

Understanding what requirements and obligations Notified Bodies might have from the beginning of the development of the device’s life cycle can provide valuable insights for future strengthening internal audits and controls. 

For example, Annex VII of the MDR outlines requirements to be met by Notified Bodies, such as organizational and general requirements, quality management requirements, resource requirements as well as process requirements, which Notified Bodies must comply with. Below are three key aspects from Annex VII that manufacturers should consider:

Risk Assessment 

Most manufacturers are currently transitioning from MDD to MDR. For Technical files to be compiled to demonstrate conformance to the MDR it’s crucial to pay attention to this requirement. During TF review by the Notified Body, a key evaluation point is review of the demonstrated conformity with Annex I of the MDR. This requires that the manufacturers make a thorough analysis of documents, which includes the analysis of the pre-clinical data, the clinical evaluation performed, and the risk management file. Information should be aligned to demonstrate compliance with the identified GSPRs from a risk perspective. 

Information Provided by the Manufacturer 

It is important for manufacturers and especially for Clinical Evaluators; that the information obtained from the Clinical Evaluation is reflected on the information provided by the manufacturer: Instructions for Use, Label, Brochure, etc. This information from the Clinical Evalutation will be evaluated during the Technical File review by the Notified Body. 

Additional information for higher class devices: According to Article 32 of the MDR, the manufacturer is required to provide information on where the device’s summary will be located. This information must be either on the label or in the instructions for use (IFU). 

However, the Notified Body has specified that the summary should be included in the instructions for use (IFU) to ensure compliance. 

The MDCG 2019-9 Rev.1 guidance document “Summary of safety and clinical performance A guide for manufacturers and notified bodies,” provides additional information on what information should be provided by the manufacturer. The full guide can be found here.  

Quality Management System 

Manufacturing sites, including suppliers and subcontractors, fall within the scope of evaluation by a Notified Body to determine whether they should be audited. If there is any change to a manufacturing site, supplier or subcontractor, the Notified Body needs to be promptly informed. This helps facilitate smoother compliance, especially during surveillance audits. 

Final Recommendations for Ensuring Regulatory Compliance with Notified Bodies under the MDR

In conclusion, we recommend that, as part of your regulatory strategy, you conduct a final review of the requirements from the Notified Body. Ensure that your documentation is in order, and if necessary, use a gap analysis tool to identify any areas needing improvement ahead of your next Notified Body visit. 

Please note that Notified Bodies will assess your compliance under the MDR. However, they are also required to ensure their own compliance with these regulations. Additionally, there may be other critical aspects relevant to your specific product that are not explicitly mentioned here but could be important to address. 

Ensure Compliance with MedEnvoy

Finally, remember that compliance is ultimately for the benefit of the end user, which could one day include you. If you have any further questions or would like to explore these topics in more detail, please do not hesitate to contact us. We are here to provide guidance and expertise in this ever-evolving regulatory landscape. To learn more about our team of regulatory experts, click here. 

Related Resources

This article is one of a series in which our key regulatory experts curated based on key findings at RAPS Convergence 2024. To read the full series, click here.