
MDCG Guidance on Borderline Between Medical Devices and Medicinal Products: Combinations
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
The final article of the cycle is dedicated to combination products and their specific regulatory nature.
The new article further describes the applicable regulatory considerations, paying additional attention to the key concepts used in the context of borderline products in order to ensure the relevant regulations are applied properly.
The new article describes in detail certain specific aspects to be taken into consideration by the parties involved in order to ensure the important information is duly communicated in accordance with the relevant regulatory requirements.
The article describes in detail the approach the UK authority intends to apply when implementing amendments to the existing legal framework.
The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.