The EU just standardized notified body timelines and costs.
Commission Implementing Regulation (EU) 2026/977 sets uniform requirements for notified bodies under both MDR and IVDR.
No more wildly different quotes, timelines, or practices between notified bodies. Here's what manufacturers can now expect:
1 / Fixed maximum timelines are now mandatory:
- 30 days for application review and contract
- 120 days for quality management system auditing
- 90 days for product verification
- 20 days for final decision and certification
2 / Cost transparency is required upfront. Notified bodies must provide detailed cost breakdowns in quotes and notify you of any increases above 10%.
3 / Timeline interruptions are limited. Each assessment phase can only be paused a specific number of times, with additional interruptions allowed when EMA or regulatory authorities are involved.
4 / Re-certification gets standardized timelines too. Product certificate renewals: 90 days maximum assessment, 20 days for decision. Quality management system certificates follow the same structure.
5 / Annual transparency reporting starts January 2028. Notified bodies must publish completion percentages, median durations, and cost data on their websites by April 30 each year.
The regulation specifically aims to harmonize notified body practices across the EU and provide greater predictability for manufacturers.
Main provisions take effect February 25, 2027 (existing agreements grandfathered). Annual reporting requirements begin January 1, 2028.