The new Medical Device Regulation (MDR) comes into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).
The MDR applies to all manufacturers selling medical devices into Europe and requires them to update both their processes and technical documentation to satisfy the new requirements.
The MDR introduces greater scrutiny of technical documentation, clinical evaluations, post-market clinical follow-ups (PMCF) and demands end-to-end traceability of medical devices through the supply chain.
All new medical devices introduced to the market after the May 2021 deadline must conform to the new MDR.
We will help you ensure your medical devices remain compliant and able to be sold in the EU.