28.01.2026
To the attention of all interested parties
The National Agency for Medicines and Medical Devices of Romania has been informed about the presence on the EU and non-EU market of a software developed by manufacturer Therapeak B.V., the Netherlands, which offers patients treatment plans, following registration on the website, completion of a questionnaire and participation in 30-minute sessions with a therapist generated by artificial intelligence, depending on the declared health condition.
Since this software has a medical purpose, for diagnosis and/or treatment of a disease, but does not meet the regulatory requirements applicable to medical devices in Regulation (EU) 2017/745 on medical devices (lack of a EU certificate of conformity issued by a Notified Body), the Competent Authority for medical devices in the Netherlands has requested the manufacturer to withdraw this non-compliant software from the EU market.
Under these conditions, the National Agency for Medicines and Medical Devices of Romania warns all interested parties to show increased attention, not to access websites that refer to this non-compliant software or, if they have already accessed it, not to consider the treatment plans generated through artificial intelligence by this software, but instead to follow the treatment plans established by medical professionals in Romania who have them on record for the respective health conditions.