The Euro­pean Commission’s Med­ical Devices Coor­di­na­tion Group (MDCG) has issued a guid­ance doc­u­ment out­lin­ing the role of the Noti­fied Body’s clin­i­cal eval­u­a­tion assess­ment report (CEAR) in assess­ing a device under Reg­u­la­tion EU 2017/745 on med­ical devices (MDR). It includes a 24-page stan­dard­ised tem­plate which Noti­fied Bod­ies should employ to record their reviews of a com­pa­nies’ clin­i­cal evaluations.

The MDCG says that “A har­monised CEAR tem­plate pro­vides a stan­dard­ised method for doc­u­ment­ing the Noti­fied Body’s assess­ment of the manufacturer’s clin­i­cal eval­u­a­tion and relat­ed doc­u­ments. CEARs in this for­mat will also sup­port spe­cif­ic addi­tion­al require­ments, such as the clin­i­cal eval­u­a­tion con­sul­ta­tion pro­ce­dure and reviews by des­ig­nat­ing authorities.”

The CEAR is a par­tic­u­lar­ly cru­cial doc­u­ment for high-risk prod­ucts that are being reviewed by expert pan­els. When car­ry­ing out a clin­i­cal eval­u­a­tion pro­ce­dure (CECP) for cer­tain class III and IIb devices, they must appraise the CEAR.

The CEAR has to give ade­quate infor­ma­tion regard­ing the clin­i­cal evi­dence giv­en by the man­u­fac­tur­er, espe­cial­ly regard­ing the ben­e­fit-risk cal­cu­la­tion, the reli­a­bil­i­ty of that evi­dence with the intend­ed pur­pose, includ­ing the med­ical indi­ca­tion or indi­ca­tions and the post-mar­ket clin­i­cal fol­low-up PMCF plan. 

The Noti­fied Bod­ies’ des­ig­nat­ing author­i­ties will have access to the com­plete audit trail of the Noti­fied Body. They will decide if the clin­i­cal eval­u­a­tion assess­ment was car­ried out cor­rect­ly, con­sid­er­ing the assess­ment, pro­ce­dures, asso­ci­at­ed doc­u­men­ta­tion and the conclusions.

The doc­u­ment may pro­vide use­ful insights also for man­u­fac­tur­ers how clin­i­cal eval­u­a­tions will be assessed under the MDR regime. 

Source: Medtech Insight (an Infor­ma product)

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