Background CE marking, granted by a notified body, is required for most implantable medical devices (IMD), except custom-made IMD and those intended for clinical investigations, before being placed on the market. IMD granted a CE marking are certified to comply with the essential requirements of council directive 93/42/EEC amended by directive 2007/47/EC.
Nevertheless, the French national drug and health products agency published an alert in May 2013 regarding a French company that had marketed a hip prosthesis without a CE marking.
Purpose To assess the conformity of the elements provided to the hospital pharmacy during the request for proposals (RFP) of 2011 by the supplier to prove the CE marking and, currently for IMD falling within Classes IIb and III.
We also wanted to draw up a method for confirming the validity of the CE marking.
Materials and methods A list of wordings for IMD falling within Classes IIb and III of the RFP has been established.
A grid summing up the modes of evaluating the conformity according to the medical device class, the evidence supporting the CE marking provided by the supplier to the hospital pharmacy as well as its expiry date, have been developed based on council directive 93/42/CEE.
From the grid we developed, three criteria were established for each wording of the RFP (WRFP) to assess the conformity of the CE marking: the whole evidence affirming the CE marking provided by the supplier, the validity of these elements for the time of the RFP and their current validity.
A rate of conformity during the RFP (RcRFP) and a current rate of conformity (RcC) have been defined according to the following formulas:
– RcRFP = (number of RFP wordings with the whole of the valid evidence affirming the CE marking during the RFP x 100)/number of RFP wordings
– RcC = (number of RFP wordings with the whole of the valid evidence affirming the CE marking at the time of the RFP and up to date x 100)/number of RFP wordings.
Results 959 RFP wordings were counted (60% were class IIb IMD and 40% were class III).
The whole evidence affirming the CE marking was provided in 60.1% of the cases (in 85.4% of the cases for the class IIb IMD and in 22.15% for the class III).
– In 98.8% of the cases, these elements were valid, leading to a RcRFP of 59%.
– Currently, the RcC equals to 19.6% (33% of the evidence provided remains valid).
– Considering the poor rate of conformity at the time of the RFP and now, it seems important to draw up a method for checking the validity of the CE marking.
Conclusions This study proves that it is necessary to check the conformity of the CE marking to secure the health of the patient. Therefore, a procedure has been drawn up to check the conformity and the validity of the CE marking whenever they are needed. The RcC will be evaluated regularly to assess the efficiency of the procedure.
No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.