Reg­u­la­tion (EU) 2024/1689 (AI Act) is set to be ful­ly imple­ment­ed for prod­ucts falling with­in the scopes of both Reg­u­la­tions (EU) 2017/745 on med­ical devices or 2017/746 on in vit­ro diag­nos­tic med­ical devices (MDR or IVDR) respec­tive­ly and the AI Act with­in three years of its pub­li­ca­tion in the Offi­cial Jour­nal of the EU (OJEU).

The date of pub­li­ca­tion was July 13 and the date of entry into force of the AI Act was August 2, 2024. The lat­ter date marks the begin­ning of the afore­men­tioned three-years tran­si­tion peri­od. We have added a brief sum­ma­ry of the main tran­si­tion­al stages:

DatePro­vi­sion
02 Feb­ru­ary 2025Pro­vi­sions on pro­hib­it­ed AI sys­tems apply (Chap­ters 1 and 2)
02 August 2025Pro­vi­sions on gen­er­al-pur­pose AI mod­els and fur­ther rules apply (e.g. Chap­ters III, V, VII)
02 August 2026Pro­vi­sions for annex III high-risk AI sys­tems apply (remain­ing AI Act except Art. 6(1))
02 August 2027Art. 6(1) applies (Annex I high-risk AI sys­tems includ­ing med­ical devices and IVDs)

It is imper­a­tive to com­pre­hend the enti­ties affect­ed by the new AI Act, dis­cern the areas of con­ver­gence and dis­par­i­ty with the MDR and IVDR, and acknowl­edge the impli­ca­tions for man­u­fac­tur­ers in the med­ical tech­nol­o­gy sector.

The ini­tial fac­tor to con­sid­er is whether the AI Act, based on a risk-based approach, is applic­a­ble to a prod­uct, and to do this, man­u­fac­tur­ers need to:

  1. Read the AI Act’s recital 12 to com­pre­hend the dis­tinc­tions between AI sys­tems and tra­di­tion­al soft­ware systems.
  2. Man­u­fac­tur­ers should always keep in mind that med­ical devices and IVD prod­ucts are typ­i­cal­ly clas­si­fied as high-risk sys­tems, irre­spec­tive of whether AI is inte­grat­ed into a hard­ware med­ical device or used as a stand­alone technology.
  3. The AI Act’s arti­cle 6 out­lines a two-step process for deter­min­ing if a med­ical device qual­i­fies as an AI sys­tem, which is a cru­cial step in under­stand­ing the AI Act’s applic­a­bil­i­ty to a product.
  4. If the prod­uct is clas­si­fied under arti­cle 6.1 and serves as a safe­ty com­po­nent for the prod­uct or AI sys­tem or is list­ed in annex I (includ­ing MDR and IVDR) and has under­gone a con­for­mi­ty assess­ment (with the excep­tion of class I devices under the MDR or IVDR), then it qual­i­fies as an AI system.
  5. In the health sec­tor, it is impor­tant to review arti­cle 6.2 and assess if the prod­uct is cov­ered by annex III of the AI Act, which includes var­i­ous sys­tems such as pri­vate and pub­lic health­care sys­tems, hence qual­i­fy­ing as an AI system.

The good news is that man­u­fac­tur­ers can stream­line com­pli­ance by using a sin­gle sys­tem for both reg­u­la­tions (AI Act and either MDR or IVDR) and obtain­ing the ser­vices of a noti­fied body for AI con­for­mi­ty assess­ments. Addi­tion­al­ly, there are sig­nif­i­cant over­laps between the AI Act’s def­i­n­i­tion of providers and the con­cept of man­u­fac­tur­ers under the MDR and IVDR. 

The MDR and IVDR bring new oblig­a­tions for providers, but some basic process­es and doc­u­ments such as qual­i­ty man­age­ment sys­tems, design con­trol, risk man­age­ment, post-mar­ket sur­veil­lance (PMS), vig­i­lance, and dec­la­ra­tion of con­for­mi­ty remain the same. The AI Act enhances these process­es with new pro­vi­sions, such as data man­age­ment, tech­ni­cal spec­i­fi­ca­tions, stan­dards, and con­troller logs.

Providers of high-risk AI sys­tems must pre­pare tech­ni­cal doc­u­men­ta­tion accord­ing to annex IV of the AI Act, includ­ing device descrip­tion, risk man­age­ment, and labelling. Spe­cif­ic con­sid­er­a­tions include aspects such as draft­ing design spec­i­fi­ca­tions, dis­clos­ing the gen­er­al log­ic and algo­rithms of the AI sys­tem, pro­vid­ing train­ing method­olo­gies and tech­nolo­gies, and others.

Stake­hold­ers will also be delight­ed to hear that the AI Act states allows for one com­bined CE mark­ing and dec­la­ra­tion of con­for­mi­ty to demon­strate con­for­mi­ty to both MDR or IVDR and the Act. 

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website