SURGI LAB achieves MDR readiness
We are delighted to announce that in November 2022, SURGI LAB successfully completed a Notified Body MDR audit. This has enabled us to receive CE mark in January 2023, meaning that SURGI LAB products can now be sold to EU markets. The achievement also demonstrates that SURGI LAB products have already met the significantly stricter safety and performance requirements arising out of the new MDR, which will become mandatory in 2028.
Notified Body audits are designed to assess the conformity of certain products before they are placed onto the market. The conformity assessment is conducted under the relevant EU regulations. In this instance, SURGI LAB products were assessed under the MDR – the new Medical Device Regulation, which is mandatory for all new medical devices to be sold in the EU.
What is the new Medical Device Regulation?
The new Medical Device Regulation, adopted in April 2017, changes the European framework for medical devices and replaces the former MDD (Medical Device Directive) with much more stringent and robust requirements.
Defined requirements to proof safety and performance of medical devices
Ensuring conformity of all partners involved, from raw material suppliers to distribution
Ongoing monitoring of risk, safety, and clinical benefit of medical device
The previous MDD came into law in 1992, and unsurprisingly, many changes within the industry have happened since then. Shocking examples had shown that manufacturers under the MDD were able to market unsafe and inferior products to their economic advantage.
Improvements in healthcare have also led to an aging population and a growing push for transparency of medical device technical information.
The new MDR incites wider compliance with standardized medical device regulations within Europe.
The Notified Body Review places manufacturers under far more scrutiny than ever before. The applicable requirements are considerably higher across the board, particularly in the areas of device performance and patient safety. As a result, the process requires considerable time and resources to achieve.