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.
Notified bodies are independent organisations designated 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.
Capacity is the constraint
As of October 2025 there were 51 notified bodies designated under the MDR. 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.
The conformity-assessment routes
- Annex IX — assessment of the full quality management system plus the technical documentation; for Class III and implantables this includes per-device technical documentation review and, where applicable, expert-panel scrutiny.
- Annex X — EU type-examination, assessing a representative device type.
- Annex XI — production quality assurance or product verification, used together with Annex X.
Broadly, Class IIa and IIb devices go via Annex IX or Annex X combined with XI; Class III via Annex IX or Annex X+XI with additional scrutiny. Class I sterile, measuring or reusable-surgical devices need notified body assessment of those specific aspects.
Simplification on the horizon
The Commission’s December 2025 proposal to revise the MDR aims to make conformity assessment more predictable — giving legal footing to structured manufacturer–notified-body dialogue and introducing assessment timelines. It is a proposal only and not yet law, so plan around today’s rules.
How PQRA helps
PQRA advises on the right conformity-assessment route, prepares you for notified body review and helps manage the relationship through certification.
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