The MDR Transition: Key Insights for MDR Certification Renewal

During RAPS Convergence 2024, one of the main topics on the agenda was the status of the transition from MDD to MDR and the expectations for the September 26, 2024, deadline. By this date, a signed agreement between manufacturers and Notified Bodies for devices transitioning from the Directives to the MDR was required to be in place.

According to the Notified Bodies, approximately 25,000 applications for MDR Certificates have been submitted, and just over 5,000 MDR Certificates have been approved as of April 2024. Next year, renewals will be a priority for most Notified Bodies, and manufacturers need to stay informed about Notified Bodies expectations.

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An Overview of MDR Certificate Renewal 

It is well known that MDR certification requires maintenance during a 5-year period. This maintenance can include planned surveillance or unplanned surveillance. Planned surveillance focuses on reviewing more technical aspects, such as the, while unplanned surveillance is based on the vigilance system that the manufacturer has developed. This requirement applies to both the Conformity Assessment through the Quality Certificates and the Technical Documentation Certificates and during the five-year period. Maintaining a certification is just as important as continuing an assessment of the certification, this is because the data obtained from your product is being marketed globally, this aspect is described further on the topics below. 

Criteria for MDR Certification Renewal

Renewing a certification is just as important as continuing an assessment of the certification, this is because the data obtained from your product is being marketed globally, the main aspects to focus on are: 

• • Continuous compliance with MDR requirements 

• • Adequate Quality management system (QMS) applied 

• • Microbiology Assessment 

• • Technical Documentation Sampling 

• • Periodic Safety Update reports  

• • Clinical evaluation and evidence updates (SSCP)

The following Table Summarizes the Assessment Performed by Notified Bodies During the 5-year Process:

Source: RAPS Convergence 2024, MDR Surveillance, Post-Certification and Recertification submissions to Notified Bodies: Best Practice for Manufacturers Common Challenges and Best Practices. Notified Bodies present on the workshop DNV, LNE GMED, BSI. 

Common Challenges and Best Practices 

Based on information shared by the Notified Bodies during RAPS, the re-certification timeline is expected to be around 12 months. But this clearly is impacted by the type of device and varies depending on the classification of the device. If the device contains Ancillary medicinal substances, it will usually take more time for revisions. This is important because unplanned maintenance can delay your renewal if substantial changes have not been properly addressed with your Notified Body. 

As part of the strategies for effective re-certification, in addition from the aspects mentioned in our previous article, it is important to keep your Periodic Safety Update reports (PSURs) and if applicable the Summary of Safety and Clinical Performance updated in your Technical File for review by the Notified Body. In addition, it is essential to keep your risk file updated accordingly and to monitor the need to update the clinical evaluation as a result of new information obtained. 

Staying informed about regulatory updates and insights is crucial for ensuring full compliance. In addition, it remains important to continue with good communication with your Notified Body and to align on anticipated changes early on. To keep yourself updated, subscribe to our newsletter today. 

Notified Bodies have identified common challenges in past MDR applications and recommend reviewing these aspects before submitting new applications. Some key considerations include: 

• • Poor quality documentation. Ensure your current documentation follows up-to-date standards  

• • Inability to close non-conformities. As part of your quality system, you must follow up non-conformities when they arise and use appropriate control tools to resolve them. 

• • Failing to inform your Notified Body of any changes during the post-certification phase can lead to delays in the renewal of your certification.  

• • Missed Audits 

• • PSURs not provided. Although the PSUR is a specific requirement of MDR, it is expected to be reviewed by your Notified Body as one of the most important documents contributing to Risk management. 

Best Practices for a MDR Re-Certification

A strong foundation of continuous compliance will help in addressing MDR re-certification, along with a robust Quality Management System meeting the applicable regulatory requirements. 

As part of the discussion about Notified Bodies during RAPS Convergence, it was emphasized that maintaining communication with your Notified Body is a crucial aspect for manufacturers and where needed to request an open dialogue discussion the topic at hand.  

It is also important to note that Notified Bodies face challenges with their workload capacity and administrative issues, but these factors are beyond the control of the manufacturer. In the meantime, we encourage manufacturers to have good communication with their Notified Bodies and stay informed with regulatory updates and official websites from the European Union and the MDCG. 

Stay up to Date on Regulatory News and Updates with MedEnvoy 

At MedEnvoy, our experienced consultants are available to assist you specifically with the involvement of a MDR Certification Renewal. Whether you have questions about the certification process, need guidance on documentation, or require support in preparing for audits, we are here to help. To connect with one of our regulatory experts and discuss your unique needs, 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.