MDR Transition for Class III Implant Manufacturer

Swiss MPC assembled a dedicated cross-functional team of senior regulatory consultants, clinical affairs specialists, and technical documentation experts. The engagement began with a comprehensive portfolio-wide gap analysis, evaluating each product family against the full scope of EU MDR Annex II (Technical Documentation) and Annex III (Post-Market Surveillance) requirements. This analysis identified over 1,400 individual documentation gaps across the 200+ product portfolio.

Based on the gap analysis findings, we developed a risk-prioritized transition roadmap that grouped products into families sharing common intended purposes, materials, and manufacturing processes. This family-based approach allowed us to create template structures and shared evidence packages, dramatically reducing redundant work while maintaining the specificity required for each individual product file.

Our clinical affairs team conducted updated Clinical Evaluation Reports (CERs) for each product family, incorporating systematic literature reviews per MEDDEV 2.7/1 Rev. 4, equivalence assessments under the stricter MDR Article 61 criteria, and identification of residual clinical data gaps requiring Post-Market Clinical Follow-up (PMCF) studies. For Class III implants, we prepared the clinical evidence packages to the heightened scrutiny standard expected by Notified Bodies under MDR.

The regulatory strategy team managed all Notified Body interactions, including pre-submission meetings, query responses, and audit preparation. We implemented a structured document management system with version control and review workflows to ensure consistency across the entire portfolio and enable efficient Notified Body review.

Throughout the project, we embedded knowledge transfer sessions with the client's internal quality and regulatory teams. This ensured the manufacturer would have the in-house capability to maintain MDR compliance for ongoing post-market obligations, product modifications, and future product launches without continued external dependency.