European trade group urges authorities to grant notified bodies access to Eudamed for risk-based oversight

A trade association representing notified bodies has formally asked EU regulators to allow them to access the Eudamed database.

The group says that such access would enable them to apply the risk-based oversight model that is central to the forthcoming medical-device regulatory reforms.

By having direct data, notified bodies could more effectively monitor device safety and compliance throughout the product lifecycle.

The request comes as the European Commission prepares to finalize the new rules, which aim to shift oversight from a prescriptive to a risk-focused approach.