CHALLENGE

​

The manufacturer had a Class I surgical instrument which had been on the market for a significant period of time. The device was well established, however the existing Clinical Evaluation Report (CER) did not meet current MDR expectations. 

​

In particular, there was no documented State of the Art (SOTA) review, and the justification for applying Article 61(10) had not been clearly defined. The Notified Body required a clear demonstration that the device was safe based on non-clinical data, supported by an appropriate SOTA analysis. 

 

SOLUTION

​

Following a review of the Technical Documentation, we updated the Clinical Evaluation in line with MDR requirements. ​A structured State of the Art (SOTA) literature search was conducted to establish current clinical practice, identify comparable devices, and confirm that the safety and performance of the instrument were well understood. 

​

Using this information, we developed a clear and robust justification for the application of Article 61(10), demonstrating that clinical investigations were not necessary due to the well-established nature of the device and its long history of safe use. 

​

The CERs were updated to reflect current guidance and aligned with MDR expectations, incorporating the SOTA findings and strengthened rationale. 

​

RESULT

​

Straightforward, compliant CERs were produced with a clear justification for the chosen conformity route. 

 

The submission was accepted with no questions raised by the Notified Body. 

​

​