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.
The new MDR includes new or revised responsibilities for manufacturers
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
Why did the MDD need to be updated?
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 effect of the new MDR
The process to receiving CE marking is now far more rigorous than under the Medical Device Directive. In addition to changes such as new classification by intended use, designation of a personal responsible for compliance and appointment of an authorized representative, manufacturers must also face a comprehensive Notified Body Review.
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.
Once a device is approved, CE marking is approved for up to five years. However, manufacturers are still required to undergo regular audits from Notified Bodies and perform extensive post-market surveillance on their device for their CE mark to be maintained.
By completing an MDR audit well before MDD ends in 2028, we have illustrated our commitment to delivering products that have already undergone extensive scrutiny and demonstrated compliance with the very highest safety and performance needed to gain regulatory approval. Ophthalmologists everywhere know that they can place their trust in SURGI LAB products.