A clos­er look at MDCG 2023-3 on vigilance

Back in March this year, we pub­lished a newslet­ter arti­cle briefly men­tion­ing the issuance of MDCG 2023-3, Ques­tions and Answers on vig­i­lance terms and con­cepts as out­lined in the Reg­u­la­tion (EU) 2017/745 on med­ical devices. This arti­cle sum­ma­rizes the most impor­tant aspects of the guid­ance document.

“As pre­vi­ous­ly men­tioned, the doc­u­ment gives spe­cif­ic advice on how man­u­fac­tur­ers should set up their vig­i­lance sys­tem under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) and can be seen as a replace­ment of MEDDEV 2.12-1.“

As pre­vi­ous­ly men­tioned, the doc­u­ment gives spe­cif­ic advice on how man­u­fac­tur­ers should set up their vig­i­lance sys­tem under Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) and can be seen as a replace­ment of MEDDEV 2.12-1. The Euro­pean Com­mis­sion announced to pro­vide an update at a lat­er stage for Reg­u­la­tion (EU) 2017/746 on in vit­ro diag­nos­tic med­ical devices (IVDR). We nonethe­less think that the doc­u­ment may gen­er­al­ly be very use­ful also for man­u­fac­tur­ers of IVD med­ical devices.

MDCG 2023-3 gives details on 20 ques­tions. There are sim­i­lar­i­ties to MEDDEV 2.12-1, but the MDCG estab­lished the reg­u­la­to­ry con­text to the MDR and the cor­re­spond­ing prin­ci­ples, def­i­n­i­tions and timelines.

Ques­tion 1 asks what is the dif­fer­ence between an inci­dent and a seri­ous inci­dent. Accord­ing to arti­cle 2(65) of the MDR seri­ous inci­dents are those inci­dents that either led to or poten­tial­ly may lead to the sig­nif­i­cant health or pub­lic health out­comes as per the afore­men­tioned MDR arti­cle. Only seri­ous inci­dents must be report­ed to com­pe­tent author­i­ties. Inci­dents only need to be report­ed if sub­ject to trend reporting.

In the fur­ther course of that sec­tion, MDCG 2023-3 includes a flow­chart out­lin­ing under which con­di­tions a com­plaint must be report­ed to com­pe­tent author­i­ties and when.

Ques­tion 2 then lays out the basic report­ing cri­te­ria for seri­ous inci­dents. Seri­ous inci­dents must be report­ed when all of the fol­low­ing con­di­tions are met:

• An inci­dent in accor­dance with arti­cle 2(64) of the MDR has occurred.
• The inci­dent direct­ly or indi­rect­ly led, might have led or might lead to 

• the death of a patient, user or oth­er person,
• the tem­po­rary or per­ma­nent seri­ous dete­ri­o­ra­tion of a patient’s, user’s or oth­er person’s state of health,
• a seri­ous pub­lic health threat.
• A causal rela­tion­ship between the seri­ous inci­dent and the manufacturer’s device has been estab­lished, is rea­son­ably pos­si­ble or suspected.

Ques­tion 2 fur­ther­more lists use­ful exam­ples for the cri­te­ria above. In this con­text, please note that not only mal­func­tions of a device are poten­tial­ly seri­ous inci­dents, but also inad­e­quate infor­ma­tion pro­vid­ed or unclear labels/ instruc­tions for use.

Ques­tions 3 to 9 add back­ground details on relat­ed word­ing and should be cross-read with the MDR def­i­n­i­tions and articles. 

Ques­tions 10, 11 and 12 dis­cuss report­ing time­lines accord­ing to arti­cle 87 of the MDR. Ques­tion 11 spec­i­fies the fol­low­ing timelines:

• any seri­ous inci­dent, that did not involve a death or an unan­tic­i­pat­ed seri­ous dete­ri­o­ra­tion in a person’s state of health, must be report­ed imme­di­ate­ly after a causal rela­tion­ship between device and the seri­ous inci­dent has been estab­lished or is rea­son­ably pos­si­ble and no lat­er than 15 days after the aware­ness date of the seri­ous inci­dent (Arti­cle 87(3) MDR), 
• a seri­ous pub­lic health threat must be report­ed imme­di­ate­ly, and not lat­er than 2 days after the man­u­fac­tur­er becomes aware of that threat (Arti­cle 87(4) MDR), 
• death or an unan­tic­i­pat­ed seri­ous dete­ri­o­ra­tion in a person’s state of health must be report­ed imme­di­ate­ly after a causal rela­tion­ship between the device and the seri­ous inci­dent is estab­lished or as soon as such rela­tion­ship is sus­pect­ed, and no lat­er than 10 days after the aware­ness date of the seri­ous inci­dent (Arti­cle 87(5) MDR).

Here as well, prac­ti­cal exam­ples and advice is giv­en so that eco­nom­ic oper­a­tors may ade­quate­ly fol­low the MDR require­ments. Ques­tions 10 and 12 on relat­ed word­ing and should be cross-read with the MDR def­i­n­i­tions and articles.

Ques­tions 14 to 16 deal with Field Safe­ty Cor­rec­tive Actions (FSCAs). Ques­tion 14 says that an FSCA in accor­dance with arti­cle 2(68) of the MDR is a cor­rec­tive action tak­en by a man­u­fac­tur­er to pre­vent or reduce the risk of a seri­ous inci­dent asso­ci­at­ed with a device that is made avail­able on the mar­ket. Ques­tion 14 also describes the process to be fol­lowed in the case of an FSCA and gives a prac­ti­cal example.

Ques­tions 15 and 16 pro­vide fur­ther back­ground details and con­text information. 

The remain­ing ques­tions 13 and 17 to 20 deal with inde­pen­dent top­ics relat­ed to vigilance.

Man­u­fac­tur­ers are high­ly advised to thor­ough­ly ana­lyze the doc­u­ment and con­sid­er poten­tial updates or clar­i­fi­ca­tions for their vig­i­lance process.

Should you have any ques­tions or con­cerns, please don’t hes­i­tate to get in touch.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

New Vig­i­lance Report­ing Tem­plates and Sup­ple­men­tary Guid­ance on Vig­i­lance Published