After four years of debate and discussion, the EU announced that an agreement has been reached pertaining to the regulation of medical devices and in-vitro diagnostics, with a specific focus of prioritizing safety and efficacy. The legislation represents substantial changes to the European healthcare environment with increased stringency in areas such as clinical evaluation, transparency and stakeholder involvement, particularly that of notified bodies. The system is designed to allow regulators to make adjustments over time as necessary and will improve the availability of clinical to data to strengthen patient safety. Device and IVD manufacturers looking to market products in Europe need to fully understand these regulations and begin the implementation process as soon as possible to remain compliant.
- In-depth review of key provisions within the regulation
- New expectations and requirements for notified bodies
- Transition time frames, deadlines and re-certification processes
Executive Director and Partner