+34 932917739 - Tecno-med Ingenieros SL NIF: ES B60945292 info@tecno-med.es

Por fin tenemos el manual para los reglamentos, con sólo 18 paginas, pero con la ambición de incluir toda la casuística

1. Regulation (EU) 2017/745 on medical devices
1.1. Qualification of medical devices
1.1.1. Borderline between medical devices and IVDs
1.1.2. Borderline between medical devices and medicinal products, including advanced therapy medicinal products (ATMPs)
1.1.3. Borderline between medical devices and biocides
1.1.4. Borderline between medical devices and substances of human origin
1.1.5. Borderline between medical devices and cosmetic products
1.1.6. Borderline between medical devices and food
1.1.7. Borderline between medical devices and personal protective equipment
1.1.8. Borderline between medical devices and general consumer products
1.1.9. Other medical device borderlines
1.2. Classification of medical devices
2. Regulation (EU) 2017/746 on in vitro diagnostic medical devices
2.1 Qualification of IVDs
2.1.1. Borderline between IVDs and medical devices
2.1.2. Borderline between IVDs and general laboratory equipment
2.1.3. Other IVD borderlines
2.2 Classification of IVDs

Este es el anterior: