On 24 June 2025, the Euro­pean Com­mis­sion released Opin­ion CECP-2025-0000232089 under the Clin­i­cal Eval­u­a­tion Con­sul­ta­tion Pro­ce­dure (CECP) for a mechan­i­cal ven­ti­la­tor used in res­pi­ra­to­ry care. This expert pan­el opin­ion assess­es the noti­fied body’s clin­i­cal eval­u­a­tion assess­ment report, offer­ing inde­pen­dent advice on clin­i­cal evi­dence suf­fi­cien­cy, ben­e­fit-risk deter­mi­na­tion, intend­ed pur­pose align­ment, and post-mar­ket fol­low-up plans. 

The opin­ion states that the clin­i­cal eval­u­a­tion assess­ment report is of poor qual­i­ty main­ly due to numer­ous errors and incon­sis­ten­cies. Sci­en­tif­ic opin­ions are a good indi­ca­tor of authority’s expec­ta­tions in the clin­i­cal eval­u­a­tion process.

Sci­en­tif­ic opin­ions are a good indi­ca­tor on the Commission’s expec­ta­tions regard­ing clin­i­cal eval­u­a­tion standards.

The full doc­u­ment can be accessed here.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website