Regulatory Open Forum

Hi everyone, 

I am trying to find any sort of information about the EU classification of a product that is a flow cytometry software analyser that uses AI, an example would be aiforia. Such products are on the market and most - if not all - of them have only complied with the FDA's CFR Part 11. 

I am trying to find out what would be the classification and regulatory requirements of such product in Europe.

Any lead would be appreciated. 

Software only, no hardware?  If it has a specific medical purpose, 2017/746 on in vitro diagnostics could apply. Otherwise, possibly

2009/24 computer programs directive

2000/31 e-commerce directive

2019/770 digital services

2016/679 general data protection

2011/83 consumer rights directive

the new AI act:  https://www.europarl.europa.eu/news/en/headlines/society/20230601STO93804/eu-ai-act-first-regulation-on-artificial-intelligence

various cybersecurity rules:  https://www.europarl.europa.eu/news/en/headlines/security/20221103STO48002/fighting-cybercrime-new-eu-cybersecurity-laws-explained