After the 2013 breast implant scandal in France , the Belgian medical device industry was a great advocate to implement an overall quality system for implantable medical devices to ensure the quality and safety. After a joint approach of the Belgian government and the medical device industry, the implants plan was developed and will be fully implemented in 2016.
The implants plan will ensure a better traceabillity of the implants from the moment they enter the market, more inspections and controls of distributors and hospitals by FAMHP and requires that a (hospital) pharmacist issues these medical devices to the patient. Another feature of the implants plan is the introduction of an “implant passport” for each patient on which information of the implant is listed. This implant passport serves as proof that the implant has followed the correct distribution network from manufacturer to the patient and can be consulted by healthcare providers and the patient.
Belgium becomes so the first country in Europe to implement such quality system for implants.
