Navigating EU-MDR Recertification and MDCG Expectations

The transition to the EU Medical Device Regulation (EU-MDR) has created significant challenges for manufacturers, particularly when it comes to recertification of legacy products and meeting new expectations around cybersecurity. With the Medical Device Coordination Group (MDCG) issuing guidance documents that expand what Notified Bodies look for, including evidence of cybersecurity risk management, manufacturers are now under pressure to demonstrate proactive, ongoing vulnerability handling across their entire product portfolio.

This regulatory tightening isn’t just about documentation, it requires technical evidence, traceability, and lifecycle management of software risks that were previously outside the scope of CE marking. That’s where ELTON comes in.

The EU-MDR and MDCG’s Cybersecurity Push

Under the EU-MDR, manufacturers must demonstrate that software risks have been identified, evaluated, and controlled throughout the product lifecycle. MDCG guidance, particularly documents like MDCG 2019-16 and more recent updates, emphasize cybersecurity as an essential component of General Safety and Performance Requirements (GSPRs). Manufacturers must also show that their processes include:

• Vulnerability monitoring and triage

• Security patch management

• Justification of unmitigated risks

• Postmarket surveillance activities related to cybersecurity

For recertification under EU-MDR, this means updating Technical Documentation to include cybersecurity risk assessment, SBOM evidence, and an established vulnerability management process, even for devices that have been on the market for years.

How ELTON Supports EU-MDR Cybersecurity Recertification

ELTON provides a platform built for Total Product Lifecycle Management (TPLM), giving manufacturers a scalable and defensible way to meet EU-MDR and MDCG cybersecurity expectations. Here’s how:

• Digital Twin Modeling
  ELTON builds a complete digital twin of your device including embedded systems, software layers, interfaces, and network connections giving Notified Bodies a clear, structured view of how cybersecurity is addressed in the system.

• SBOM Surveillance and Risk Prioritization
  ELTON continuously monitors SBOM components across all releases, flags new CVEs, and evaluates whether they are exploitable in the actual system context. This supports MDCG-required vulnerability handling and helps justify why certain findings do or do not require remediation.

• Postmarket Vulnerability Management
  ELTON fulfills the need for continuous postmarket surveillance by maintaining a living view of each product’s vulnerability state. Manufacturers can show historical tracking, triage decisions, remediation actions, and risk-based justifications all mapped to specific device releases and software updates.

• Audit-Ready Outputs and CAPA Support
  Every decision in ELTON is logged, time-stamped, and traceable enabling clean documentation that can be shared with Notified Bodies during recertification. When vulnerabilities are deferred or justified, ELTON stores the rationale and system context, fulfilling CAPA and PMS requirements under EU-MDR.

Staying Ahead of Recertification Risk

With thousands of devices requiring EU-MDR recertification by 2027 and Notified Bodies increasingly focused on software risk and cybersecurity maturity, manufacturers cannot afford to rely on spreadsheets, siloed testing, or ad hoc vulnerability management.

ELTON offers a proven, regulatory-aligned solution that reduces the burden of recertification, helps close gaps in legacy technical files, and ensures every software-driven device, whether in development or postmarket, has a cybersecurity posture that meets both EU-MDR and MDCG expectations.

Now is the time to operationalize cybersecurity as a core part of your product lifecycle. ELTON can help you get there.