The EU has standardized notified body timelines and cost transparency for medical device and IVD manufacturers.
Commission Implementing Regulation (EU) 2026/977 sets uniform requirements for notified bodies under both the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The goal is to make notified body selection more predictable, especially for SMEs that need clearer quotes, timelines, and assessment practices.
Fixed maximum timelines are now mandatory. Manufacturers can expect:
- 30 days for application review and contract
- 120 days for QMS auditing
- 90 days for technical documentation assessment
- 20 days for final decision and certification
Cost transparency is required upfront. Notified bodies must provide detailed cost breakdowns in quotes and notify manufacturers of any increases above 10%.
Timeline interruptions are limited. Each assessment phase can only be paused a specific number of times, ranging from one to five interruptions depending on the activity.
Re-certification timelines are standardized too. Product certificate renewals have a 90-day maximum assessment period and 20 days for the decision. QMS certificate renewals follow the same structured timing approach.
Annual transparency reporting starts in January 2028. Notified bodies must publish completion percentages, median durations, and cost data so manufacturers can compare performance using more consistent information.
Most provisions take effect on February 25, 2027, with existing agreements grandfathered. Re-certification requirements apply from November 25, 2027.