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欧盟(欧盟医疗器械法规MDR) replaces the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Devices (AIMD) Directive 90/385/EEC. The EU MDR includes a series of critical improvements to modernize the current system and streamline scientific progress that has occurred in the medical device space over the last 20 years. It prioritizes the safety of medical devices through more robust clinical evidence, post-market surveillance, and information transparency. The new regulations apply to all medical device manufacturers who are looking to place their products in the EU market. Since by May 2025 the devices that were CE Marked under the MDD may no longer be marketed in EU, medical device OEMs need a strong partner for compliance.

Cyient supports the complete transition from MDD to MDR—from gap assessment through post-market surveillance, technical documentation including Design History File (DHF), and Risk Management File (RMF) preparation. With hands-on experience in successfully implementing MDR projects for our clients, we are well positioned to support companies through their MDR compliance journey.

Our Phased Service Offerings

Phase-1

Phase I: Assessment

Collate a list of impacted products placed in the EU market. For all the listed products conduct an MDD to MDR gap analysis including risk-classification. Assess Quality Management System (QMS), Design History File (DHF), Risk Management File (RMF) and clinical data for MDR requirements.

Phase-2

Phase II: Pilot & Planning

Prepare technical documentation template and evidence based technical document template. Pilot remediation with good representation of technical file and validation with Notified Bodies. Plan for implementation.

Phase-3

Phase III: Remediation and CE Mark

Remediate DHF, CER, RMF and DMR. Update files as per the general safety and performance requirement update (GSPRU). Carry out PMS and post-market clinical follow-up (PMCF). Conduct V&V where necessary. Support in internal and external audits.

Phase-4

Phase IV: Sustenance

Ensure MDR compliance throughout product lifecycle by maintaining technical file, Design History File, Risk Management File and Post-Market Surveillance file as well as UDI labelling compliance. Update EUDAMED regularly.

Phase I: Assessment

Phase II: Pilot & Planning

Phase III: Remediation and CE Mark

Phase IV: Sustenance

The Cyient Advantage

  • Substantial exposure in developing content for all the sections of the Technical Documentation: Biocompatibility, DQT, EMC, V&V, AOV, Integration, etc.
  • Implemented multiple MDR transition projects for established OEMs, medium sized firms and start-ups including helping a top-10 diagnostic imaging company transition to MDR within six months’ time-frame.
  • Developed reusable templates for quicker time-to-market

*Reference Official Journal of the European Union (OJEU)

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