Next steps for the sector as paper-based IFUs give way to digital alternatives.
Regulators in the life sciences industry are making clear moves to connect patients, physicians and other stakeholders across the healthcare system by implementing e-labelling initiatives.
The goal of these initiatives is to ensure a sustainable and consistently up-to-date information source for product and safety information that isn’t dependent on paper.
This eBook assesses the latest regulatory expectations and timelines applicable to the medical device industry. It then sets out the practical next steps manufacturers and suppliers can take now – both to prepare for compliance and to maximize the opportunities operationally and for customers.
What is included:
- Current expectations in the EU: How the EMA is handling e-labelling
- Transitioning to e-labelling: What are the key benefits to your business?
- Impact on Regulatory Affairs: Control of accurate, structured content
- Impact on the Labelling Department: A look at the significant impacts for this department
- Impact on Infrastructure: What elements must be considered to ensure a smooth transition
- Practical next steps to create and execute a well-coordinated e-labelling strategy and plan
- Several resources such as:
- Current e-labelling initiatives around the globe
- Medical device requirements and key compliance dates for the EU and the UK