Medral Global provides comprehensive CE Marking Services for Medical Devices and In Vitro Diagnostic (IVD) devices in India, enabling manufacturers to comply with the European Union’s Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746). With deep regulatory expertise and a thorough understanding of EU compliance requirements, we support Indian and global companies in achieving CE certification, a critical step for entering the European Economic Area (EEA).
Our end-to-end services cover everything from regulatory strategy to technical documentation, including clinical evaluation reports, software validation, and EU authorized representative support. Medral Global’s goal is to simplify the regulatory journey, reduce delays, and ensure your medical devices meet the highest standards for safety, quality, and performance.
EU MDR Compliance
Medral Global is well-versed in the EU MDR 2017/745, which introduces stricter requirements for device approval, focusing on areas such as post-market surveillance, clinical data, and risk management. We help manufacturers prepare robust technical files and clinical evaluation reports (CERs) that demonstrate product safety and efficacy throughout the device’s lifecycle. Our team ensures your documentation aligns with MDR standards, reducing the risk of delays or rejections during the certification process.
EU IVDR Compliance for IVD Devices
We also specialize in CE Marking for In Vitro Diagnostic devices (IVDs) under EU IVDR 2017/746, which has introduced a more rigorous classification and documentation system. Medral Global assists IVD manufacturers in correctly classifying devices, preparing performance evaluation reports, and managing required clinical investigations to meet evolving IVDR expectations. Our support ensures that your IVD products are fully compliant and ready for successful market entry into Europe.
Technical File Development
A technical file is mandatory for CE certification and must comprehensively detail your product’s design, intended use, risk assessments, and supporting evidence. Medral Global assists in creating these technical files in strict accordance with EU MDR and IVDR standards. By ensuring completeness and accuracy, we help minimize delays during the assessment and approval process.
Clinical Evaluation Reports (CERs) & Performance Evaluation
Under MDR, all medical devices must be backed by a Clinical Evaluation Report that clearly demonstrates their safety and performance using relevant clinical data. Medral Global offers end-to-end support in drafting, reviewing, and maintaining CERs that meet the latest EU guidelines. Similarly, for IVDs, we help create Performance Evaluation Reports (PERs), ensuring all performance data is documented and compliant with IVDR requirements.
Software Validation for SaMD and SiMD
With digital health rapidly evolving, software validation is now a critical component of CE certification. Medral Global delivers Software Validation Reports for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), ensuring that all software components function safely and as intended. These reports comply with both MDR and IVDR regulations and are essential for digital medical products entering the EU market.
European Authorized Representative Services
For non-EU manufacturers, appointing an Authorized Representative in Europe is a regulatory requirement. Medral Global offers EU Authorized Representative Services, acting as your official contact point within the EU. We handle communications with competent authorities, manage regulatory submissions, and ensure your products remain compliant throughout their lifecycle.