Back in Decem­ber 2023, the Med­ical Device Coor­di­na­tion Group (MDCG) pub­lished sev­er­al new guid­ance documents. 

MDCG 2023-5, Guid­ance on qual­i­fi­ca­tion and clas­si­fi­ca­tion of Annex XVI prod­ucts: Accord­ing to the scope state­ment of the doc­u­ment, the guid­ance pro­vides details that are help­ful for the “qual­i­fi­ca­tion of a prod­uct as a prod­uct with­out an intend­ed med­ical pur­pose list­ed in Annex XVI to the MDR. It also pro­vides expla­na­tions and exam­ples for the appli­ca­tion of cer­tain clas­si­fi­ca­tion rules to prod­ucts with­out an intend­ed med­ical purpose.”

MDCG 2023-6, Guid­ance on demon­stra­tion of equiv­a­lence for Annex XVI prod­ucts: As for med­ical devices, also man­u­fac­tur­ers of prod­ucts with­out a med­ical pur­pose may use clin­i­cal data from equiv­a­lent devices for estab­lish­ing the clin­i­cal eval­u­a­tion. This may become a chal­lenge if the equiv­a­lent device has a med­ical pur­pose or a med­ical and a non-med­ical pur­pose. The doc­u­ment pro­vides guid­ance on these aspects. 

MDCG 2023-7, Guid­ance on exemp­tions from the require­ment to per­form clin­i­cal inves­ti­ga­tions pur­suant to Arti­cle 61(4)-(6) MDR and on ‘suf­fi­cient lev­els of access’ to data need­ed to jus­ti­fy claims of equiv­a­lence: Accord­ing to arti­cle 61(4) of the MDR, clin­i­cal inves­ti­ga­tions must be con­duct­ed for class III and implantable devices unless the con­di­tions for excep­tions apply (e.g. demon­stra­tion of equiv­a­lence, etc.). As per the scope state­ment, the guid­ance aims to clar­i­fy the exemp­tions from the require­ment to per­form clin­i­cal inves­ti­ga­tions, and asso­ci­at­ed con­di­tions relat­ed to the demon­stra­tion of equivalence. 

MDCG 2021-6,Reg­u­la­tion (EU) 2017/745 – Ques­tions & Answers regard­ing clin­i­cal inves­ti­ga­tion: The ini­tial ver­sion of the guid­ance was pub­lished in 2021. Revi­sion 1 was now issued in Decem­ber. The updat­ed doc­u­ment includes numer­ous new ques­tions and answers as well as updat­ed ques­tions and answers. In addi­tion, a new annex III was added that pro­vides a flow­chart to eval­u­ate if a com­bi­na­tion prod­uct study requires a clin­i­cal inves­ti­ga­tion submission.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website