EFLM position statement on IVDR revision

EFLM position statement on the IVDR revision, highlights key implementation challenges and considerations with a focus on Article 5.5 and maintaining patient safety and access to reliable diagnostics.

EFLM has issued a position statement addressing the European Commission’s legislative proposal 2025/0404(COD), published on 16 December 2025, concerning the targeted revision of Regulation (EU) 2017/746 (IVDR).

It has been noted that the implementation of the IVDR had introduced significant challenges, including certification bottlenecks, test shortages, and reduced availability of innovative diagnostic solutions. These issues affect both CE-IVD commercial tests and in-house IVDs (IH-IVDs), with direct implications for healthcare institutions, SMEs and patient care.

Through its Committee for European Regulatory Affairs (C-ERA), EFLM has reviewed the proposed revision, highlighting key strengths and areas requiring further attention, particularly regarding Article 5.5 on in-house testing. Patient safety and access to reliable diagnostics remain central to this assessment.

 
Please see below attachemnts for further information:
 
EFLM position statement

 

EFLM position statement on IVDR amendment of article 5.5