Man­u­fac­tur­ers are inter­est­ed in the capac­i­ty of noti­fied bod­ies in the med­ical devices field and the time it takes for them to con­duct audits after a writ­ten agree­ment. This infor­ma­tion is not pub­licly avail­able his­tor­i­cal­ly due to dif­fi­cul­ty pre­dict­ing timelines. 

BSI recent­ly stat­ed it is gain­ing more expe­ri­ence in con­duct­ing reviews under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR), lead­ing to increased effi­cien­cy. Man­u­fac­tur­ers are also show­ing greater aware­ness of the require­ments for a smooth con­for­mi­ty assess­ment process. This con­ver­gence is result­ing in reduced over­all time­lines accord­ing to BSI. 

BSI lead times for QMS audits for all codes under the MDR are three months or less. Micro­bi­ol­o­gy audits for devices asso­ci­at­ed with steril­i­ty, dis­in­fec­tion, clean­ing, etc. have under two months lead times. Regard­ing the assess­ment of tech­ni­cal doc­u­men­ta­tion (mea­sured as the aver­age time BSI takes to start the review once it has received the com­plete tech­ni­cal doc­u­men­ta­tion), lead times range from one to six months.

Almost all prod­ucts fall into the cat­e­go­ry of one month or less, while the fol­low­ing gen­er­al­ly high­er-risk prod­ucts fall into longer categories:

It remains to be seen if oth­er noti­fied bod­ies will fol­low and make sim­i­lar infor­ma­tion pub­lic that would make the dura­tion of con­for­mi­ty assess­ments more reliable.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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