The Com­pe­tent Author­i­ties for Med­ical Devices (CAMD) work­ing group recent­ly pub­lished a Q&A doc­u­ment on free sales cer­tifi­cates (FSCs) under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR).

A legal­ized FSC acts as a proof of com­pli­ance with the EU reg­u­la­to­ry sys­tem. It is con­sid­ered a fast and cost-effi­cient way to sell prod­ucts in mar­kets out­side the Euro­pean Union with­out an own reg­u­la­to­ry system.

The Q&A doc­u­ment answers basic ques­tions, e.g. who is respon­si­ble for issuance and to whom FSCs are typ­i­cal­ly issued. The paper also pro­vides gen­er­al infor­ma­tion on the details that must be includ­ed in the appli­ca­tion for an FSC.

Should you be inter­est­ed in the doc­u­ment, please let us know and we will be hap­py to provide.

Source: CAMD

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website