Promotion of Joanna Weitz to Chief Operating Officer
News & Press Releases・
5 min read
Medical device manufacturers (MDMs) have various resources to ensure compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Recently, the EU extended these deadlines, giving manufacturers more time for compliance. For instance, conformity assessments for higher-risk devices (class IIb and class III) are now due in 2027, while lower-risk devices (classes IIa and I) have until 2028.
However, these deadlines are still rapidly approaching, and compliance can often take quite a bit of time to finalize. Here, we outline seven proactive measures that life sciences companies can take to prepare for EU MDR and IVDR compliance.
The first step towards compliance is gaining a comprehensive understanding of the complex EU MDR and IVDR regulations. Without this, medical device manufacturers may inadvertently violate regulatory requirements, leading to non-compliance and potential legal consequences. Engaging regulatory experts or partnering with consultants experienced in EU directives is essential. It’s also important to regularly watch for updates from the European Medicines Agency (EMA) and the European Commission to stay on top of the latest information.
Conducting a thorough gap analysis is really important when assessing your current processes, documentation, and quality management systems in relation to the EU MDR and IVDR regulations. This evaluation helps avoid surprises by pinpointing areas of non-compliance and providing a clear path for necessary corrective actions.
Both MDR and IVDR emphasize the importance of precise documentation, covering clinical data, risk assessments, technical documentation, and post-market surveillance. Advanced document management systems are useful to ensure that life sciences companies are working with organized, version-controlled, and accessible documents. Safeguarding data integrity and security is also required. Robust data management practices, such as encryption and comprehensive audit trails, are essential to protect sensitive patient data and regulatory information.
EU MDR and IVDR stipulate that product documentation, including labels, instructions for use, and risk assessments are in official EU Member State languages. Collaborating with experienced language service providers (LSPs) to localize this kind of content is essential to meet this requirement. LSPs offer the linguistic skills and regulatory expertise to produce accurate translations for EU compliance and communication with healthcare professionals and patients.
Companies must establish thorough procedures to identify, assess, mitigate, and monitor risks across the product lifecycle. Clinical evaluations, post-market surveillance, and vigilant reporting ensures products are safe for use, comply with regulatory standards, and are effective in their clinical application.
A vital step for compliance with EU MDR and IVDR is enhancing post-market surveillance systems to continually assess the safety and effectiveness of products after they enter the market. This includes regular monitoring of user feedback, adverse event reporting, and clinical data analysis. Effective post-market surveillance not only ensures ongoing compliance with regulatory standards but also helps in promptly identifying and addressing potential product issues.
Multilingual training for staff on MDR and IVDR regulations ensures better engagement, understanding, and adherence across regions. It’s important for companies to develop these training programs to cover all essential regulatory aspects in the native languages of their employees, enhancing their ability to implement these regulations effectively.
The extension of EU MDR and IVDR deadlines offers medical device manufacturers a crucial period for compliance. While it may be tempting to slow down, it’s not the time for MDMs to relax their efforts. Instead, this period should be seen as an opportunity to fully align with EU MDR and IVDR standards. MDMs can use this time to refine their compliance strategies, ensuring a smoother transition and avoiding potential challenges in the future.
Get in touch
We are committed to giving you freedom of choice while providing subject matter expertise and customized strategies to fit your business needs.Contact us