Strategies for Medical Device Manufacturers to Overcome MDR 2017/745 Compliance Challenges and Secure CE Certification

India, December 04, 2024: Europe, comprising 27 EU member states, is one of the world's largest and most advanced markets, serving over 500 million consumers. CE Marking is mandatory for every medical device sold within the EU and the European Economic Area (EEA), making it an essential certification requirement for companies aiming to access this lucrative market. Renowned and highly sought after, the CE Mark holds a unique position in the global medical devices trade. CE-marked products often enjoy easier entry into other regulated markets, such as Australia, the Middle East, India, and parts of Asia, where CE compliance is regarded as a benchmark of quality and safety. Beyond regulatory compliance, the CE Mark also serves as a powerful marketing tool, building trust among stakeholders and boosting market share in competitive regions.

Medical device manufacturers planning to enter or continue selling in the European Union (EU) with CE Marking often find it very challenging after the release of the regulation MDR 2017/745. This is due to stricter documentation requirements, the limited availability of Notified Bodies, the exorbitant fee hikes by Notified Bodies and the availability of experienced internal resources. Under the new MDR, manufacturers must provide detailed technical documentation, robust clinical evidence, and post-market surveillance data to secure or maintain CE certification. These changes replace the more lenient framework of the previous Medical Device Directive (MDD), creating additional hurdles for manufacturers aiming for EC Certification.

Impact on Medical Device Manufacturers

The financial burden is especially severe for smaller manufacturers. Some companies have reportedly invested substantial amounts in Notified Bodies and testing, but long delays in the clearance of technical and clinical documentation have forced them to postpone new product launches or withdraw certain products from their current CE-marked list. Jane Doe, CEO of Star Medical Factory JSC, voiced her concerns:

"The rising cost of document reviews, prolonged delays in document review, and shortage of Notified Bodies are making it increasingly difficult for smaller manufacturers to complete CE certification. Additionally, there is a substantial shortage of qualified personnel to handle the extensive clinical evaluations required."

Technical Expert Insight

Soio George, a regulatory expert from I3CGLOBAL, commented, “The new MDR enforces stricter adherence to EU General Safety and Performance Requirements (GSPR), requiring manufacturers to ensure that their devices' quality, safety, efficiency and performance align with their intended use. Furthermore, manufacturing units must fully comply with the (EN) ISO 13485:2016 standard for medical device quality management systems. Appointing the right consulting organization, with experienced consultants guided by a dedicated project manager, is vital for effectively meeting these rigorous requirements.”

To overcome these challenges, manufacturers are advised to begin preparing documentation well in advance, engage with Notified Bodies early in the process, and partner with regulatory consultants for guidance on technical and clinical evaluations.

Additionally, regulatory experts recommend that manufacturers closely monitor the actions of competitors, budget early for Notified Body fees, and account for consulting and testing costs. It is crucial to work closely with experienced consultants to streamline documentation and testing processes, ensuring that all requirements are met efficiently. By doing so, manufacturers can significantly reduce the risk of technical documentation and clinical evaluation report rejection by the Notified Body and avoid costly delays in the approval process. Early planning and expert guidance help ensure compliance and minimize the potential for setbacks during the EC certification process.

Conclusion

As EU MDR compliance becomes increasingly complex and costly, proactive planning and expert guidance are more critical than ever. Manufacturers who strategically allocate resources and collaborate with experienced regulatory consultants can reduce the risk of Notified Body rejection and avoid extended delays in the review process, ensuring a more streamlined and efficient route to CE marking for their medical devices. In essence, early collaboration with an experienced consulting team helps to avoid costly setbacks, ensures adherence to MDR 2017/745 requirements, and accelerates the process of obtaining the CE certification for your devices.

Tags

CE Marking

CE Certification

Medical Device CE Marking

I3CGLOBAL

MDR 2017/745

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