Inspection of genetic diagnostic centers
Published on 7 April 2025
The Agence de la biomédecine's inspection mission involves on-site visits to ensure the security of authorizations issued in its areas of activity, in particular:
- multidisciplinary prenatal diagnosis centers (CPDPN) ;
- pre-implantation diagnostic centers (CDPI);
More generally, it is also involved in risk assessment and analysis for all activities in the field of procreation, prenatal and preimplantation diagnosis, human genetics, embryo research and human embryonic stem cell (hESC) preservation.
Inspection of multidisciplinary prenatal diagnosis centers (CPDPN)
The Agence de la biomédecine is responsible for inspecting multidisciplinary prenatal diagnosis centers (CPDPN) each time a new authorization is requested or renewed.
On-site inspections take place in three main stages
- Opening meeting: the inspector introduces the site manager and key personnel to the activity being inspected, outlining the purpose and scope of the inspection, and the planned schedule.
- Conduct of the inspection: discussions, tour of facilities, consultation of documents and files; as the inspection progresses, the findings are presented to the manager.
- Closing meeting: presentation to the person in charge of the discrepancies and remarks observed, and of the contradictory procedure.
The three stages of the inspection report leading to a final, contradictory document
- Stage 1 (C1 or preliminary): the preliminary report brings together the information gathered and the findings made during the inspection (list of discrepancies or remarks observed); it is sent to the inspected party within a reasonable timeframe.
- Stage 2 (C2 or the inspected party's response): the report is enriched with observations that the inspected party may make for each discrepancy or remark mentioned in the first stage, within a set timeframe.
- Stage 3 (C3 or final report): the inspector responds to the inspector's observations.
A provisional conclusion in stage 1 and a definitive conclusion in stage 3 must address all the points covered by the mission, and must enable an overall assessment to be made of the activity concerned. The final conclusion presents an overall opinion based on all the positive and negative elements observed during the inspection.
Follow-up inspections may be carried out to ensure that corrective actions proposed by the inspected party following previous inspections have been implemented.
Find out more
Inspection of Preimplantation Diagnostic Centers (CDPI)
The Agence de la biomédecine (French Biomedicine Agency) is responsible for inspecting Preimplantation Diagnostic Centers (CDPI) whenever a request for authorization or renewal of authorization is made.
On-site inspections take place in three main stages
- Opening meeting: the inspector introduces the site manager and key personnel to the activity to be inspected, outlining the purpose and scope of the inspection, and the planned schedule.
- Conduct of the inspection: discussions, tour of facilities, consultation of documents and files; as the inspection progresses, the findings are presented to the manager.
- Closing meeting: presentation to the person in charge of the discrepancies and remarks observed, and of the contradictory procedure.
The three stages of the inspection report leading to a final, contradictory document
- Stage 1 (C1 or preliminary): the preliminary report summarizes the information gathered and the findings made during the inspection (list of discrepancies or observations); it is sent to the inspected party within a reasonable timeframe.
- Stage 2 (C2 or the inspected party's response): the report is enriched with observations that the inspected party may make on each discrepancy or remark mentioned in the first stage, within a set timeframe.
- Stage 3 (C3 or final report): the inspector responds to the inspector's observations.
A provisional conclusion in stage 1 and a definitive conclusion in stage 3 must address all the points covered by the mission, and must enable an overall assessment to be made of the activity concerned. Follow-up inspections may be carried out to ensure that corrective actions proposed by the inspected party following previous inspections have been implemented.
Other genetic activities
Prenatal diagnosis laboratories
Medical biology laboratories are authorized by the director general of the regional health agency. Project to draw up an inspection grid for PND activities (cytogenetic analyses, genetic examinations on free fetal DNA circulating in maternal blood, molecular genetic examinations, biochemical examinations on maternal serum markers).
Genetic Diagnostic Laboratory
Medical biology laboratories are authorized by the director general of the regional health agency. Project to draw up an inspection grid for genetics activities
Share