Regulatory Open Forum

Good afternoon, forum.

Can anyone direct me to which regulations would apply in EU to a "high-speed, vial filling robot for 'behind the counter' pharmacy/clinical use?" There is no intended use/indications for use statement that make it an actual medical device that I can find. Further, a clinician or pharmacist or someone with appropriate credentials would be required to operate, monitor, and check the output prior to providing to customer. 

What regulations would apply to this type of robot/machine and/or what other information would I need to determine an appropriate regulatory strategy?

Any insight welcome. Thank you!

Good afternoon, forum.

Can anyone direct me to which regulations would apply in EU to a "high-speed, vial filling robot for 'behind the counter' pharmacy/clinical use?" There is no intended use/indications for use statement that make it an actual medical device that I can find. Further, a clinician or pharmacist or someone with appropriate credentials would be required to operate, monitor, and check the output prior to providing to customer. 

What regulations would apply to this type of robot/machine and/or what other information would I need to determine an appropriate regulatory strategy?

Any insight welcome. Thank you!

In addition to what Armin mentioned: probably also batteries regulation if it has a battery for uninterrupted power supply (many of these robots do). RED if the robot has a wireless interfacing capability. EMC (since MDR is not applicable EMC needs to happen separately). EUP (Energy using products) may apply. GDPR will necessitate some software design requirements if the robot processes personal data (e.g. if it combines patient data with a barcode on the vial). And don't forget the almost adopted AI Regulation in case the robot qualifies as an AI system.

Good afternoon, forum.

Can anyone direct me to which regulations would apply in EU to a "high-speed, vial filling robot for 'behind the counter' pharmacy/clinical use?" There is no intended use/indications for use statement that make it an actual medical device that I can find. Further, a clinician or pharmacist or someone with appropriate credentials would be required to operate, monitor, and check the output prior to providing to customer. 

What regulations would apply to this type of robot/machine and/or what other information would I need to determine an appropriate regulatory strategy?

Any insight welcome. Thank you!