A CER is a report based on in-depth analysis of clinical data which contains information regarding a medical device or an equivalent device. This report determines that whether the device was successful in achieving its intended purpose without posing risk for its users or not.
EU MDR and CER
CER is mandatory for all manufacturers who wish to put their medical device in Union’s market. The report must be submitted to Notified Body. Another important step to obtain your CER is that you must obtain European CE Technical File. It is mandatory to submit CER with European CE Technical File.
The new regulations brought up by EU demand a more comprehensive evaluation report regarding medical device’s clinical evaluation. You will be required to update your CER continuously as a part of your post-market surveillance and vigilance activities. Any new and noticeable changes should be made the part of your report or otherwise you will lose the conformity of your device within the Union’s market.
Need Help in Preparing Your CER?
Maintaining a proper CER along with CEP and literature research according to the standards is not an easy and effortless task. You have to maintain and meet all the requirements otherwise your device will be at risk of getting in the European Union’s market. Therefore; why not compliance experts for CER look after this for you?
Contact TS Q & E as we are always ready to help you out in formation of your CER and CEP reports along with comprehensive literature research. We have an experience of over a decade in this field and our services are spanned all over the Europe.