The introduction of the European Union Medical Device Regulation (EU MDR) 2017/745 marked a significant milestone in the world of medical devices. It brought about stricter regulations and increased transparency to ensure patient safety and product efficacy. While obtaining the CE mark is a crucial step for medical device manufacturers, it's equally important to understand the post-CE compliance requirements under EU MDR. In this blog, we'll explore these requirements in-depth and help you navigate this essential phase of product lifecycle management.
Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF):
Under EU MDR, manufacturers must establish robust PMS and PMCF systems. PMS involves actively and systematically gathering, analyzing, and interpreting data on the performance and safety of a medical device throughout its entire lifecycle. PMCF is mandatory for higher-risk Class IIb and III devices. It involves the collection of clinical data from the post-market phase to confirm the device's safety and performance as demonstrated in the clinical evaluation. PMCF data helps manufacturers assess whether there are any unexpected issues or adverse events associated with the device during real-world use.
Manufacturers are required to report any serious incidents or field safety corrective actions (recalls) immediately to the competent authorities in the EU member states where they have devices on the market. Timely and accurate reporting is crucial to addressing safety concerns promptly. Serious incidents must be reported to the competent authority within 15 days of becoming aware of the incident. Non-serious incidents must be included in an annual summary report submitted to the competent authority. Manufacturers are required to analyze and report on trends related to incidents and adverse events. This involves identifying patterns or recurring issues and taking corrective actions to mitigate risks.
Periodic Safety Update Reports (PSURs):
Manufacturers of Class IIa, IIb, and III medical devices must prepare and submit PSURs to competent authorities. These reports provide a comprehensive overview of the safety and performance of the device based on data collected during post-market surveillance activities. PSURs are typically submitted annually, but the frequency may vary depending on the risk classification of the device.
Quality Management System (QMS) and ISO 13485:
Manufacturers must maintain a robust QMS that complies with ISO 13485:2016. Regular audits, assessments, and updates to the QMS are necessary to ensure continued compliance with EU MDR requirements. It's important to note that the frequency of surveillance audits is tied to the certification cycle. ISO 13485 certification is typically valid for a three-year period. During this time, surveillance audits are conducted to ensure ongoing compliance. At the end of the three-year cycle, a recertification audit is required to renew the certification. Many certification bodies typically conduct surveillance audits on an annual basis. This means that organizations with ISO 13485 certification can expect to undergo a surveillance audit once every year. Annual audits help ensure ongoing compliance and provide a regular check on the organization's Quality Management System (QMS). Some certification bodies may choose to conduct surveillance audits every two years (biennially) for organizations with a well-established track record of compliance and a lower risk profile. This frequency is less common but may be considered for organizations with a strong history of maintaining their QMS.
Labeling and Instructions for Use (IFU):
Device labeling and IFUs must remain accurate and up-to-date. Any changes to the device, its intended use, or safety information should be reflected in the labeling and IFU, and these updates should be communicated to users and regulatory authorities as necessary.
Unique Device Identification (UDI):
Compliance with UDI requirements is mandatory under EU MDR. Manufacturers must ensure that their devices are appropriately marked with UDIs and that this information is accessible in the EUDAMED database.
Clinical Evaluation and Performance Evaluation Reports:
Regularly review and update your clinical evaluation and performance evaluation reports to align with the latest data and safety information. This is critical for demonstrating the continued safety and efficacy of your device. The frequency of updates depends on the
device's risk class, complexity, and intended use. Manufacturers should define a specific schedule for CER and / or PER updates. Collect relevant clinical data, including real-world performance data, adverse events, and any new scientific literature or clinical studies that pertain to the device. Ensure that the data collection process is systematic and well- documented.
Notified Body Interaction:
Manufacturers should maintain a constructive relationship with their chosen Notified Body (NB). NBs may conduct regular audits and assessments to ensure ongoing compliance with EU MDR requirements.
Device Modifications and Recertification:
Any significant changes or modifications to your medical device may require recertification and resubmission to the Notified Body. Ensure you understand the criteria for determining when recertification is necessary.
Cooperation with Competent Authorities:
Be prepared to cooperate fully with competent authorities in case of any inquiries, inspections, or investigations related to your medical device. Transparency and responsiveness are key in such situations.
Achieving CE compliance is a significant achievement, but it's only the beginning of your responsibilities as a medical device manufacturer under EU MDR. Post-CE compliance requirements are designed to ensure ongoing safety and effectiveness. Navigating this phase successfully requires diligence, a commitment to data-driven decision-making, and a proactive approach to regulatory changes.
Staying informed about updates to EU MDR and other relevant regulations is vital to maintaining compliance throughout the lifecycle of your medical device. By prioritizing post- CE compliance, you not only meet regulatory obligations but also contribute to the safety and well-being of patients relying on your products.
Ready to Ensure Ongoing Compliance? Contact Artixio Today!
Navigating post-CE compliance requirements under EU MDR can be complex, but you don't have to do it alone. Artixio’s team of experts is here to help you through every step of the process. Contact us today to ensure that your medical device continues to meet the highest standards of safety and effectiveness. Your commitment to compliance is our top priority. Let's work together to safeguard patients and bring innovative healthcare solutions to the European market.