{"id":378,"date":"2026-08-11T10:08:50","date_gmt":"2026-08-11T08:08:50","guid":{"rendered":"https:\/\/www.pqra.gr\/notified-bodies-and-conformity-assessment-under-the-mdr\/"},"modified":"2026-08-27T11:37:06","modified_gmt":"2026-08-27T09:37:06","slug":"notified-bodies-and-conformity-assessment-under-the-mdr","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/notified-bodies-and-conformity-assessment-under-the-mdr\/","title":{"rendered":"Notified Bodies and Conformity Assessment Under the MDR"},"content":{"rendered":"

For any device above Class I, a notified body stands between you and the CE mark. Understanding how they work — and why capacity is tight — is essential to a realistic launch plan.<\/strong><\/p>\n

Notified bodies are independent organisations designated<\/strong> under the MDR through a joint assessment by the national authority, the Commission and a joint assessment team. Designations are listed in the Commission’s NANDO database.<\/p>\n

Capacity is the constraint<\/h2>\n

As of October 2025 there were 51 notified bodies designated under the MDR<\/strong>. Numbers have grown slowly, and capacity remains a recognised bottleneck — the underlying reason for the certification backlog and the successive transition-deadline extensions. Securing a notified body slot early is now part of the timeline, not an afterthought.<\/p>\n

The conformity-assessment routes<\/h2>\n