BioMed Alliance welcomes the adoption of the European Commission's Proposal to amend the transitional provisions of the IVDR following the favourable vote of the Council yesterday, 20 December 2021 and its adoption in plenary at the European Parliament last week. The adoption of the Proposal was necessary to ensure proper implementation of the IVDR and avoid potentially disastrous consequences for the diagnostic sector. As representatives of many specialties involved in innovative diagnostics, we are particularly relieved that the amended transitional provisions include those involving in-house testing.

However, work still needs to be done to provide the necessary guidance and documents enabling a safe and timely transition to the new framework:

  1. Compliance to the IVDR will be a major effort for diagnostic laboratories, requiring trained personnel, additional time and budget. The Commission must take this into account and put forward solutions to support laboratories in minimising the rising costs.
  2. Guidance documents are urgently needed in order to help diagnostic laboratories to properly conduct the transformations required from the IVDR.
  3. Clarification on modified use of CE-IVD and RUO (research use only) tests is necessary in order to allow labs to take appropriate steps for their safe and legitimate use under the IVDR.

We look forward to continuing our collaboration with the European Commission and to supporting the key actors in accelerating the efforts to optimise diagnostic practise according to the Joint Implementation Plan.

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