Navigate My EU Compliance
What You Are Dealing With
You are a medical device company selling or planning to sell in the European market and the EU MDR and IVDR requirements are significantly more demanding than the directives they replaced. The technical documentation requirements, notified body process, clinical evaluation standards, and post-market surveillance obligations all represent a substantial increase in workload and complexity. The timelines are real and notified body capacity is constrained. If your transition planning is behind or your technical files are not ready, access to the European market is at risk.
How We Approach It
We start with a gap assessment to establish your current compliance state against EU MDR or IVDR requirements and build a realistic transition plan from there. We support technical documentation development, QMS alignment to ISO 13485, clinical evaluation report preparation, notified body interaction, and post-market surveillance program development. We work at the pace your timeline requires.
What We Have Done
A company developing drug eluting bioresorbable coronary scaffolds engaged MEDVACON to prepare the drug dossier required for CE submission in Europe. MEDVACON reviewed program status, organized requirements for the MHRA drug module, managed assignments and planning, and delivered final review and comments to the client team to support submission.
A medical device manufacturer engaged MEDVACON to support its transition from MDD to EU MDR. MEDVACON conducted a comprehensive gap assessment against MDR requirements, supported updates to technical documentation and quality systems, and helped align clinical, risk management, and post market surveillance processes with current regulatory expectations. This positioned the client to maintain CE marking under the new regulatory framework without disruption to market access.