The Spanish Agency for medicines and Medical Devices (AEMPS) has published a regulatory consultation service to clarify the qualification and classification of medical devices and in-vitro diagnostic medical devices.
How does this new service work?
- The purpose of this service is to give regulatory support and guidance on product qualification and classification, as well as promoting innovation.
- The target audience for this service are MedTech industry developers and manufacturers.
- AEMPS decides on product qualification and classification applicable to each specific product based on its intended purpose and primary mode of action.
- Consultations are primarily via meetings or, in exceptional cases, through written reports, generally occurring one month after the confirmed request. A final report is issued within 90 days of request, concluding the procedure. Please note that the AEMPS’ advice is non-binding.
- The cost per product consultation is 211.61€.
This initiative is a significant step towards clarifying regulatory pathways and fostering MedTech innovation. For those developing or reclassifying products in light of new regulations, this is an invaluable support mechanism.
Click here to read the full article: AEMPS CONSULTATION SERVICE FOR MEDICAL DEVICE CLASSIFICATION
For further details or to initiate a consultation, do not hesitate to contact us: [email protected]
