A Clinical Evaluation Report (CER) is a safety and performance assessment report of any medical device based on the clinical data related to it. The clinical data is either collected through clinical investigation or by availing previously collected data of a substantially equivalent device. To sell a medical device in Europe, it is compulsory for manufacturers to prepare an accurate CER to obtain CE marking certification. If the CER is not compliant with the regulations of the Notified Bodies (NB), the manufacturers may not be able to place their devices on the market or they may have to repeat the evaluations of all the clinical data that has been rejected or failed.
With the continuous changes in the Regulatory landscape of Medical Device Registration (MDR), the emphasis on relevant clinical data and suitable approach for the documentation of the CER is increasing. Yet, many manufacturers face challenges in case of unannounced review or inspection by a notified body.
Challenges for Manufacturers
Some manufacturers consider the clinical evaluation as a one-time process. Contrary to which, clinical evaluations are on-going procedures which take place throughout the product lifecycle that requires continuous assessment and update of the clinical data through activities like post-market surveillance or risk management activities etc. Manufacturers also need to keep in mind the overall time required to prepare CERs, since authoring multiple CERs take adequate time and need expert resources.
Are You Aligned with MEDDEV 2.7/1 Revision 4?
In 2016, Europe’s Medical Device Registration has introduced new set of guidelines under MEDDEV 2.7/1 revision 4 which will take effect from mid-2020. The revision gives more stringent rules for requirement of clinical data and clarification on the aspects of clinical evaluation which were ambiguous earlier.
Are you willing to market your medical device in Europe? Then you should be knowing that the clinical data you submit through Clinical Evaluation Report (CER) is under heavy scrutiny by the notified bodies and competent authorities in Europe. Post the publication of MEDDEV 2.7/1 Revision 4, the scrutiny has even become stringent. The clinical data you integrate into the reports must be compliant and should be accurate enough to identify the aspects of safety and performance of the respective device.
To know more about what type of data is required for CERs and how it should be authored, compiled and submitted in-line with the latest EU MDR’s MEDDEV 2.7/1 rev 4, join us for our Free Webinar on “Clinical Evaluation Report (CER) – Decode the Step-wise Approach for Compliance”, on 11th December, 2018; 9:00 AM EST. Ensure you be compliant while entering European market.