Team-NB Highlights Risk-Adaptive Surveillance under the MDR and IVDR
The European Association of Medical Devices Notified Bodies, Team-NB, has presented a briefing note on risk-adaptive surveillance under the MDR and IVDR.
The note explains Team-NB’s proposal for a more proportionate approach to notified body surveillance, aiming to reduce unnecessary burden while maintaining patient safety and effective regulatory oversight.
A More Proportionate Surveillance Model
Team-NB notes that medical devices require continued monitoring after being placed on the EU market.
The key question is not whether surveillance should continue, but how it can become more proportionate.
According to the briefing note, a blanket reduction in surveillance could create safety risks. Instead, Team-NB proposes a smarter model that reduces routine oversight where there is evidence that the manufacturer and its devices are performing well.
What Risk-Adaptive Surveillance Means
Risk-adaptive surveillance would increase oversight where risks, new concerns or weak compliance are present.
At the same time, it would allow lower routine oversight where manufacturers can demonstrate stable compliance and strong post-market performance.
The model would also allow immediate escalation where serious incidents, recurring non-conformities, poor responsiveness, negative vigilance trends or other safety signals arise.
Policy Value
Team-NB highlights that a risk-adaptive approach could help keep patient safety central while reducing unnecessary routine checks.
It could also allow notified bodies to focus capacity on higher-risk manufacturers, devices and situations.
For well-performing manufacturers, the approach may reduce routine oversight and potentially lower notified body effort and manufacturer compliance costs.
Fairness to Early MDR and IVDR Adopters
The briefing note also refers to fairness for early MDR and IVDR adopters.
Team-NB notes that the first MDR certificates were issued in 2019 and the first IVDR certificates in 2020. Manufacturers that moved early to MDR or IVDR compliance have had several years to build evidence of conformity, post-market performance and quality system stability.
Risk-adaptive surveillance could allow these manufacturers to be recognised where the evidence supports it, rather than being treated in the same way as manufacturers that waited until the end of the transition periods.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, Team-NB’s proposal is relevant because it points toward a more evidence-based and proportionate surveillance model.
Manufacturers should pay particular attention to:
post-market performance evidence;
quality system stability;
vigilance trends;
responsiveness to notified body requests;
recurring non-conformities;
serious incidents and safety signals;
long-term MDR and IVDR compliance history;
opportunities to demonstrate sustained conformity.
For manufacturers, the key message is that strong compliance performance and robust post-market data may become increasingly important in supporting a more proportionate notified body surveillance approach.
