Notified Body Readiness
Securing certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) represents one of the most complex milestones in the lifecycle of a medical device. Despite technical competence, many organisations face significant challenges during Notified Body (NB) assessments due to incomplete documentation, inconsistent narratives, or insufficient audit preparation. The resulting delays, non-conformities, and repeated submission cycles can jeopardise commercialisation plans, strain resources, and erode stakeholder confidence. In today’s environment of limited Notified Body capacity and increasing regulatory scrutiny, structured readiness is no longer optional, it is a strategic necessity.
Our Notified Body Readiness services provide an end-to-end framework to prepare organisations for successful certification. We begin with a comprehensive diagnostic review of existing documentation, evaluating alignment with MDR and IVDR Annex II and III requirements, ISO 13485:2016 standards, and applicable MDCG guidance. Each document is assessed not only for completeness but also for coherence, ensuring that evidence, claims, and risk controls form a consistent and verifiable narrative across the technical file, clinical evaluation, and quality management system.
Identified gaps are prioritised by regulatory impact and addressed through targeted remediation. Our consultants support the development of robust corrective and preventive actions (CAPA), enhancement of risk management documentation, integration of post-market surveillance plans, and strengthening of clinical evaluation evidence where required. This process transforms fragmented or legacy documentation into a structured, audit-ready submission package that withstands scrutiny and minimises clarification rounds.
In parallel, we assist with Notified Body selection and engagement strategy. Given variations in scope, review timelines, and interpretive approaches across NBs, early alignment between manufacturer expectations and NB capacity is critical. We support the selection process, evaluate contractual obligations, and coordinate submission sequencing to align with your regulatory and commercial timelines.
The outcome of our readiness program is a clear and verifiable state of preparedness that can be demonstrated internally and externally. Clients benefit from shorter review cycles, fewer non-conformities, and stronger professional relationships with Notified Bodies. Equally important, readiness initiatives often lead to broader organisational improvements, enhanced documentation discipline, improved cross-functional coordination, and a deeper understanding of regulatory logic across departments.
By applying a methodical, evidence-based approach to readiness, we help organisations transform certification from an unpredictable process into a controlled, transparent, and achievable milestone. The result is a smoother path to CE marking, a reduction in regulatory risk, and greater confidence in the organisation’s ability to sustain compliance over time.
For further information or to discuss how our Notified Body Readiness services can strengthen your certification outcomes, please contact our regulatory compliance team.
