Blog from May, 2025

gematik is introducing a new, more flexible approach to scheduling approval test slots for TI-M Pro. Effective immediately, the process outlined in the updated procedure description for product approval (gemZul_Prod_TI-M_Pro) has been revised to enhance efficiency and reduce delays. This approach addresses three primary issues:

Manufacturers no longer need to endure lengthy waiting periods if they have a later testing slot.
Missed reserved test slots will not result in manufacturers being placed at the end of the queue.
Test slots will be shorter and smoother, enhancing predictability for your release dates.

Instead of assigning fixed time slots for approval tests, gematik will now provide short-term testing dates once manufacturers have fully met the required entry criteria. These criteria will be carefully verified and approved by gematik before a test date is issued. To ensure readiness for the approval test, manufacturers must fulfill the following entry criteria:

Internal Testing (EvT): A test report from the manufacturer’s internal testing must be submitted, demonstrating a 100% pass rate. Exceptions are allowed only for defects that can be clearly and verifiably attributed to external factors beyond the manufacturer’s responsibility.
Reference Implementation Testing: A test report from testing with gematik’s reference implementation must also show a 100% pass rate, with the same exception for external defects.
Comprehensive Test Documentation:
- Test Concept
- Test-Requirement-Matrix
- Test Case Specifications
Advance Notice: Manufacturers must provide at least 10 working days' notice before submitting all deliverables.

This updated approach benefits both manufacturers and gematik by minimizing delays in scheduling approval tests and optimizing the use of testing resources. Looking ahead, gematik plans to extend this streamlined scheduling process to TI-M ePA approvals and will provide further updates in due course. This change reflects gematik’s commitment to fostering a more efficient and collaborative approval process, ensuring that all stakeholders can move forward with confidence and clarity.