The Med­ical Device Coor­di­na­tion Group (MDCG) issued a guid­ance doc­u­ment to help man­u­fac­tur­ers of class I med­ical devices to com­ply with Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR). 

It gives a gen­er­al overview of the over­all require­ments that are applic­a­ble for these types of devices and also explains which aspects man­u­fac­tur­ers should con­sid­er. The doc­u­ment address­es spe­cif­ic issues like the Gen­er­al Safe­ty and Per­for­mance Require­ments and the prepa­ra­tion of tech­ni­cal files.

From a first review it is more or less in line with the rec­om­men­da­tions mdi Europa has com­mu­ni­cat­ed over the past. And although the doc­u­ment may not answer each and every ques­tion, we high­ly rec­om­mend to review the guid­ance. It should be care­ful­ly read and inter­pret­ed in con­junc­tion with the cor­re­spond­ing MDR sections. 

Source: MDCG guid­ance document

We rec­om­mend the fol­low­ing sources for in depth information

Browse our web­site by key­word. 
Vis­it our cor­re­spond­ing Down­load Sec­tion regard­ing MDR.
Read our arti­cle “Tech­ni­cal Doc­u­men­ta­tion Require­ments under the MDR – a Case Study”.
Vis­it our page “Major Aspects of the MDR“.
Vis­it our page “Major Aspects of the IVDR“.