The EU NIS 2 Directive Is Here. What Does It Mean For Medtech?
Executive Summary
The EU Network and Information Security (NIS) Directive 2 entered into force this year, replacing the original NIS Directive. Cybersecurity is at the heart of NIS 2, and some of the new provisions are particularly important for the medtech and health sector.
You may also be interested in...
EMA Begins Setting Up New Bodies To Tackle Medical Product Shortages
A new EU regulation has come into effect that gives the European Medicines Agency wider powers to monitor, prevent and manage shortages of drugs and medical devices in public health emergencies. A number of steering groups and other bodies and networks are being set up to put the new systems into action.
EU Stakeholders Devise Six-Point Plan To Improve Cross-Border Clinical Trials
Sponsors need guidance on ethics requirements and clarity around national regulations to conduct cross-border clinical trials in the EU, a multi-stakeholder forum says.
EU Needs Market Access Improvements Beyond New HTA Regulation
While the EU Health Technology Assessment Regulation could reduce divergence in reimbursement decisions made across member states, many national-level HTA hurdles and challenges will remain, market access experts from EFPIA say.