Successful EU-MDR audit enables renewed certification

Transitioning from the Medical Device Directive 93/42/EEC (MDD) to the EU-MDR significantly increases documentation and process requirements. Following a notified body audit that identified 12 major non-conformities, VTS, a manufacturer of a Class IIb active medical device, engaged Ramboll to implement timely corrective actions and maintain certification.

The findings affected multiple parts of the TD and the QMS, including the declaration of conformity (DoC), EU-MDR classification and coding, post market surveillance (PMS), monitoring of QMS effectiveness, design and development records, change reporting to the notified body (NB), document control, clinical evaluation, and risk management.

We structured the process into two focused steps to ensure rapid progress while maintaining regulatory robustness.

Step 1: Document review and remediation planning

This step defined the scope, priorities, and resource requirements, forming the basis for targeted and efficient remediation.

Key activities:

• Intake and scoping: Consolidated NB findings, reviewed the TD and QMS documentation, and conducted stakeholder interviews to clarify ownership of each process and historical context.
• Gap analysis: Mapped each NB finding to relevant TD sections and QMS procedures through a clause-by-clause assessment against EU-MDR requirements and NB non-conformity statements.
• Impact assessment: Evaluated each non-conformity based on patient safety risk, potential certification delay, and the level of effort required (eg minor updates vs. major rewrites).
• Prioritisation and sequencing: Recommended a remediation sequence reflecting regulatory urgency and logical dependencies (eg resolving classification before finalising the DoC and labelling).

The consolidated gap analysis report linked each NB finding to specific document sections, providing a clear and structured basis for remediation. This approach prevented rework, reduced unexpected issues during audits, and enabled efficient use of specialist resources by converting NB observations into a practical roadmap with a realistic cost expectation and timeline

Step 2: Remediation: addressing the identified non-conformities

For each non-conformity, we combined targeted drafting and process updates with stakeholder workshops and version control, followed by internal verification and pre‑audit checks. Where documentation or procedures were insufficient, we provided ready‑to‑use EU-MDR‑compliant templates and trained the client in their application. We also coordinated required submissions to the notified body (eg for reported changes).

Key efficiency drivers:

• Quality and completeness of existing TD and QMS documentation
• Availability of internal subject matter experts (SMEs) for interviews, clinical data, and test results
• Need for additional studies, testing, or literature reviews
• Notified body timelines and responsiveness to change notifications

Results and client value

The client received a clear, prioritised remediation roadmap with defined deliverables and responsibilities, which minimised certification delays. Ramboll delivered Revised procedures, EU-MDR‑aligned templates, and corrected TD sections, along with targeted staff training. The focused remediation and audit preparation enabled a successful QMS and product audit, helping the client achieve EU-MDR certification.