Updat­ed Blue Guide and MDR and IVDR har­mo­nized standards

The Euro­pean Com­mis­sion keeps pub­lish­ing new doc­u­ments. A key doc­u­ment that pro­vides the reg­u­la­to­ry foun­da­tion for many CE marked devices, among oth­ers med­ical and IVD med­ical devices is the Blue Guide. The Blue Guide is a hor­i­zon­tal guid­ance doc­u­ment that clar­i­fies con­cepts like plac­ing on the mar­ket, prin­ci­ples of CE mark­ing and oth­er essen­tial aspects. It should be cross-read with reg­u­la­tions like (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). The fol­low­ing new ver­sion was published:

• ‘Blue Guide’ on the imple­men­ta­tion of EU prod­uct rules 2022 

Fur­ther­more, the Com­mis­sion con­tin­ues expand­ing the list of har­mo­nized stan­dards under MDR and IVDR:

• The MDR and IVDR now also list EN ISO 14971:2019. Indus­try anx­ious­ly wait­ed for this step.

We high­ly rec­om­mend to keep a close eye on the devel­op­ment of the har­mo­nized stan­dards list. The Euro­pean Com­mis­sion is expect­ed to pro­vide updates every 3 to 4 months.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website 

• New cyber­se­cu­ri­ty standard 
• EN ISO 13485 and sym­bols stan­dards har­monised under the EU’s IVDR
• Stan­dard ISO 20417:2021 for the MDR and IVDR published