The Euro­pean Com­mis­sion issued a num­ber of updates just recent­ly. Here is a brief summary.

Bor­der­line manual

On April 22, revi­sion 5 of the bor­der­line man­u­al was issued. It pro­vides reg­u­la­to­ry ratio­nale for a num­ber of new prod­ucts, e.g. a penis hol­ster, a syringe con­tain­ing glass beads and nee­dles for root canal irrigation. 

The doc­u­ment can be down­loaded here. 

EMDN codes

Also on April 22, infor­ma­tion on EMDN codes was updat­ed. This includes the annu­al revi­sion log, a sum­ma­ry of sub­mis­sions and relat­ed out­comes and an update to MDCG 2021-12, the relat­ed FAQ doc­u­ment. Espe­cial­ly the lat­ter has been expand­ed with new ques­tions 6, 7, 8 and 11. 

The doc­u­ments can be down­loaded here. 

MIR

Fol­low­ing the MDR 7.3.1 update, the Com­mis­sion pro­vid­ed on May 7 new man­u­fac­tur­er inci­dent report ver­sions along with XSD and XSL files (SB files 11154). These are intend­ed for man­u­fac­tur­er data­bas­es and can be down­loaded here.

Nation­al require­ments for clin­i­cal inves­ti­ga­tions and per­for­mance studies

On April 22, the Com­mis­sion pro­vid­ed an overview of nation­al require­ments for clin­i­cal inves­ti­ga­tions and per­for­mance stud­ies. The table pro­vides coun­try spe­cif­ic infor­ma­tion and informs among oth­ers on autho­riza­tion and noti­fi­ca­tion require­ments as well as Ethics Com­mit­tee requirements.

The file can be accessed here. 

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website