Back in 2019, the Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished guid­ance MDCG 2019-6, a Q&A doc­u­ment relat­ed to require­ments around noti­fied bod­ies. The Com­mis­sion has now issued revi­sion 3 of the paper. An insight­ful aspect has been added under sec­tion I.6. This part address­es to what extent noti­fied bodes may pro­vide pre-cer­ti­fi­ca­tion services.

The guid­ance clar­i­fies that pre-cer­ti­fi­ca­tion ser­vices (e.g. review of clin­i­cal data or assess­ment of the qual­i­ty man­age­ment sys­tem) are not allowed unless an appli­ca­tion is lodged by the manufacturer.

The noti­fied body may still pro­vide train­ings out­side con­for­mi­ty assess­ment activ­i­ties. But these should not be client-spe­cif­ic and not intend­ed by only one manufacturer/ rel­e­vant sup­pli­er and they should also not be con­duct­ed at the manufacturer’s or supplier’s premises. 

Addi­tion­al details are includ­ed in the paper. Please let us know should you wish us to send you a copy. You may also vis­it our library sec­tion for addi­tion­al rel­e­vant documents.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website