Q&A on oblig­a­tion to inform in case of interruption/ dis­con­tin­u­a­tion of sup­ply chain published

Amend­ing Reg­u­la­tion (EU) 2024/1860 intro­duced under arti­cle 10a of Reg­u­la­tions (EU) 2017/745 and 2017/746 (MDR and IVDR) the oblig­a­tion of eco­nom­ic oper­a­tors to alert com­pe­tent author­i­ties and the mar­ket in the case of inter­rup­tion or dis­con­tin­u­a­tion of the sup­ply chain for cer­tain devices. 

The arti­cle will apply as of Jan­u­ary 10, 2025.

The Com­mis­sion has pub­lished a Q&A doc­u­ment that lays out the most impor­tant ques­tions and answers. It adds, among oth­ers, details to the questions:

• To whom does the oblig­a­tion to inform of an antic­i­pat­ed inter­rup­tion or dis­con­tin­u­a­tion of sup­ply of cer­tain devices under Arti­cle 10a(1) of the MDR/IVDR apply? 

• Who should the man­u­fac­tur­er inform under Arti­cle 10a (1) of the MDR/IVDR? 

• What is meant by the “antic­i­pa­tion of an ‘inter­rup­tion or dis­con­tin­u­a­tion’ of the sup­ply of a device” as out­lined in Arti­cle 10a (1) of the MDR or IVDR?

• What are the cat­e­gories of rea­sons for the inter­rup­tion or dis­con­tin­u­a­tion which the

man­u­fac­tur­er would be expect­ed to spec­i­fy in its noti­fi­ca­tion to the com­pe­tent author­i­ty under Arti­cle 10a (1) of the MDR/IVDR? 

• What is con­sid­ered as an ‘inter­rup­tion or dis­con­tin­u­a­tion that may result in seri­ous harm or a risk of seri­ous harm to patients or pub­lic health’ in one or more Mem­ber States under Arti­cle 10a (1) of the MDR/IVDR? 

It remains to be seen in how far the doc­u­ment is real­ly help­ful. The oblig­a­tion to iden­ti­fy affect­ed devices is sole­ly with the man­u­fac­tur­er. Details for assess­ing if prod­ucts fall into the cat­e­go­ry sug­gest­ed by arti­cle 10a appear rather vague.

The doc­u­ment can be accessed here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Amend­ing Reg­u­la­tion (EU) 2024/1860 pub­lished in the OJEU
• Browse our web­site with tag “Guid­ance Doc­u­ments“