Why device classification shapes everything that follows
Understanding MDR Structure and Device Classification, Episode 1 of MDR Made Simple webinar series
The European Union’s Medical Device Regulation (MDR) has reshaped the landscape for medical device manufacturers. Far from being just a replacement for the MDD, it sets a higher bar for safety, transparency, and accountability. At the heart of this transformation lies a pivotal question: how is your device classified?
Classification is far from a box-ticking exercise. It determines the clinical evidence required, the technical documentation to be prepared, and the conformity assessment route to CE marking. Get it right and you create a clear pathway to market. Get it wrong and you risk delays, extra costs, or even loss of market access.
To support manufacturers in meeting these requirements, DNV launched the MDR Made Simple webinar series, a four-episode programme offering practical insights into classification, documentation, clinical evaluation, and quality management systems, the essential foundations of MDR compliance. In our opening episode, Understanding MDR Structure and Device Classification, we explored how MDR differs from MDD, what CE marking really means for manufacturers, and how the EU’s risk-based rules shape classification outcomes. The introduction of Class Ir for reusable surgical instruments, and practical examples such as urinary catheters, showed how these decisions are applied in practice.
The key insight: Classification is more than compliance. It is a strategic decision point that influences product design, regulatory planning, and business continuity.
As an MDR-designated Notified Body, DNV is authorised by the European Commission to independently assess whether medical devices meet MDR requirements and can be CE marked. For manufacturers, this means partnering with DNV provides the assurance that classification decisions, conformity assessment routes, and supporting documentation are evaluated against the highest regulatory standards. It is a mark of trust not just for regulators, but for healthcare providers and patients as well.
And this is only the start. The next episode in our MDR Made Simple webinar series will dive into Technical Documentation under MDR: what a compliant file must include, how to structure it effectively, and what to avoid to ensure MDR expectations are met.
At DNV, we combine our role as a Notified Body with deep technical expertise to guide companies confidently through MDR compliance. For us, it is not just about certification, it is about enabling safer, more effective devices to reach the people who need them.
10/16/2025 7:00:00 AM
