MDCG has published guidance MDCG 2020-12 on transitional provisions for consultations of authorities on devices incorporating a substance, which may be considered a medicinal product […] as well as on devices manufactured using TSE susceptible animal tissues.
Read it here: Text for Guidance MDCG-12
Also check out the FDA Combination Products Guidance here
Classification and regulatory management of these products could actually forestall a Manufacturer’s operations unless properly identified. Contact Evnia for tailored resources on drug-device combination products that will accelerate your compliance with Regulations!
Download the file in .pdf format from here
MHRA’s PMS requirements per device class
January 24, 2025
