FREE consultation 9871231133

Clinical Evaluation Mandatory for All Medical Devices in Europe

Clinical Evaluation Mandatory for All Medical Devices in Europe

Clinical Evaluation Mandatory for All Medical Devices in Europe. As per the 2007 amendment in MDD 2007/47/EC related to the clinical evaluation of the Medical Device states that every medical device sold in Europe, regardless of its classification, must have a Clinical Evaluation Report in its technical file.
This means that all classes of medical devices i.e class I, II, III require a clinical evaluation.
what led to this change? In June 2002, a report by the European Commission’s Medical Device Experts Group (MDEG) concluded that most manufacturers did not possess adequate clinical evidence for their medical devices and that most notified bodies didn’t adequately verify the clinical evidence that was provided to them by manufacturers. The findings applied to all the classes of device.In addition, the MDEG cited clinical evaluations as a major area of concern. The MDEG is composed of representatives from various organizations in Europe and each member state’s competent authority. .


  • I would like to thank entire team of Meddevices for your assistance and guidance in obtaining ISO & CE certification. Your help will be instrumental in our continued growth & success.

    Arul Pragyasam
  • Thank you Meddevices! They have tackled all aspects of my CE case in a very short period of time. They are by far the best team I have worked with..

    Karen Roberston
  • I wouldn’t think of facing an FDA audit without Meddevices’s Assistance..

    Gerhard frick
  • I deeply appreciate the outstanding service that Meddevices have provided us over the last ten years..

    Gregony Denton


Company Info

MED DEVICES LIFESCIENCES LIMITED was formed to provide medical device manufacturers world-wide with flexible and well adjusted service packages to assist its clients to comply with EU & US legislation .

Med Devices 123 fifth Avenue
New York, NY 10160
Ph: +19142942185

Quick Form

2015 MedDevices. All Rights Reserved