The Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished a revi­sion of its clas­si­fi­ca­tion guid­ance for med­ical devices under Reg­u­la­tion (EU) 2017/745 (MDR) — MDCG 2021-24 Rev.1— updat­ing the orig­i­nal Octo­ber 2021 document.

Key changes span ref­er­ence infor­ma­tion and details as well as sev­er­al rules, but rule 8 (implantable and long-term sur­gi­cal­ly inva­sive devices) sees the most sub­stan­tive updates:

– Implantable device def­i­n­i­tion broad­ened: “Sur­gi­cal pro­ce­dure” replaced by “clin­i­cal pro­ce­dure” — explic­it­ly cov­er­ing both sur­gi­cal and non-sur­gi­cal implan­ta­tion pathways.

– Spinal hooks reclas­si­fied: Hooks that fix rods on the spinal col­umn are now explic­it­ly list­ed as class IIb (gen­er­al rule), not class III. New note 7 clar­i­fies these are treat­ed sim­i­lar­ly to the exist­ing exemp­tion for screws, wedges, plates and instruments.

– New note 1 address­es Arti­cle 52(4) to pre­vent mis­read­ing of the IIb assess­ment require­ments as a clas­si­fi­ca­tion driver.

Oth­er updates touch rules 2, 9, 10, 12, 16 and 22.

Man­u­fac­tur­ers espe­cial­ly those work­ing with implantable devices in the spinal and orthopaedic space should review their clas­si­fi­ca­tion ratio­nales in light of the new revision.

The updat­ed guid­ance can be found here.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website