MDR appli­es even for pro­ducts wit­hout an inten­ded medi­cal purpose

The fast approach of 26 May 2020, the date of appli­ca­ti­on for the Medi­cal Device Regu­la­ti­on, has the medi­cal devices indus­try hol­ding its breath. Manu­fac­tu­r­ers of con­ven­tio­nal medi­cal devices are alre­a­dy taking advan­ta­ge of the tran­si­tio­nal peri­od sin­ce the MDR took effect to ensu­re that their com­pa­nies, pro­ces­ses and pro­ducts are MDR-compliant so as to avo­id the thre­at of a marketing/sales free­ze for non-conforming products.

But the MDR does not app­ly just for “con­ven­tio­nal” medi­cal devices. Artic­le 1(2) of the MDR, in con­junc­tion with Annex XVI of the MDR, express­ly includes pro­duct groups WITHOUT an inten­ded medi­cal pur­po­se. As a result, the MDR will app­ly even to manu­fac­tu­r­ers, importers and users of pro­ducts which had pre­vious­ly been unre­gu­la­ted by medi­cal devices law.

In par­ti­cu­lar, the gene­ral safe­ty and per­for­mance requi­re­ments for “con­ven­tio­nal” medi­cal devices also app­ly for pro­ducts in accordance with Annex XVI. This means that, when used for the pur­po­se inten­ded, the pro­duct must pose a risk that is no more than the maxi­mum accep­ta­ble risk, or no risk at all, con­sis­tent with a high level of pro­tec­tion for the health and safe­ty of users.

The requi­re­ment for demons­t­ra­ting a cli­ni­cal bene­fit will also app­ly for the pro­ducts wit­hout an inten­ded medi­cal pur­po­se men­tio­ned in Annex XIV, just as they do for “con­ven­tio­nal” medi­cal devices. The cli­ni­cal eva­lua­tions for the­se pro­ducts must be per­for­med based on rele­vant data con­cer­ning safe­ty, inclu­ding data from post-market sur­veil­lan­ce, post-market cli­ni­cal follow-up (PMCF) and, whe­re appli­ca­ble, spe­ci­fic cli­ni­cal inves­ti­ga­ti­ons. The per­for­mance of cli­ni­cal inves­ti­ga­ti­ons for the pro­duct groups spe­ci­fied in Annex XVI may only be dis­pen­sed with if reli­ance on exis­ting cli­ni­cal data from an ana­log­ous medi­cal device is duly justified.

Annex XVI of the MDR con­ta­ins a list of pro­duct groups wit­hout an inten­ded medi­cal pur­po­se for which the pro­vi­si­ons of the MDR will app­ly in man­da­to­ry fashion as of 26 May 2020. The fol­lo­wing pro­duct groups will be affected:

  • “Cont­act len­ses or other items inten­ded to be intro­du­ced into or onto the eye.
  • Pro­ducts inten­ded to be total­ly or par­ti­al­ly intro­du­ced into the human body through sur­gi­cal­ly inva­si­ve means for the pur­po­se of modi­fy­ing the ana­to­my or fix­a­ti­on of body parts with the excep­ti­on of tat­too­ing pro­ducts and piercings.
  • Sub­s­tances, com­bi­na­ti­ons of sub­s­tances, or items inten­ded to be used for facial or other der­mal or mucous mem­bra­ne fil­ling by sub­cu­ta­neous, submu­cous or intrader­mal injec­tion or other intro­duc­tion, exclu­ding tho­se for tattooing.
  • Equip­ment inten­ded to be used to redu­ce, remo­ve or des­troy adi­po­se tis­sue, such as equip­ment for lipo­suc­tion, lipo­ly­sis or lipoplasty.
  • High inten­si­ty elec­tro­ma­gne­tic radia­ti­on (e.g. infra-red, visi­ble light and ultra-violet) emit­ting equip­ment inten­ded for use on the human body, inclu­ding coher­ent and non-coherent sources, mono­chro­ma­tic and broad spec­trum, such as lasers and inten­se pul­sed light equip­ment, for skin resur­fa­cing, tat­too or hair rem­oval or other skin treatment.
  • Equip­ment inten­ded for brain sti­mu­la­ti­on that app­ly elec­tri­cal curr­ents or magne­tic or elec­tro­ma­gne­tic fields that pene­tra­te the cra­ni­um to modi­fy neu­ro­nal acti­vi­ty in the brain.”

(Annex XVI, EU-Regulation 2017/745)

Addi­ti­ons to this list can­not be ruled out: the Com­mis­si­on is aut­ho­ri­zed to adopt dele­ga­ted acts in order to add more pro­duct groups to the list in Annex XVI. It can do so when jus­ti­fied on account of the simi­la­ri­ty bet­ween a device with an inten­ded medi­cal pur­po­se which has been pla­ced on the mar­ket and a pro­duct wit­hout a medi­cal pur­po­se in respect of their cha­rac­te­ristics and risks.

Manu­fac­tu­r­ers, importers and dis­tri­bu­tors of the pro­ducts men­tio­ned in Annex XVI of the MDR should the­r­e­fo­re be awa­re that their com­pa­nies and pro­ducts will be sub­ject to the pro­vi­si­ons of the MDR: the duties of eco­no­mic ope­ra­tors in terms of the MDR will app­ly to them as well. A product’s fail­ure to con­form to the pro­vi­si­ons of medi­cal devices law may ulti­m­ate­ly result in a mar­ke­ting or sales free­ze and fail­ure to com­ply with the MDR may result in civil lia­bi­li­ty as well as pro­duct liability.


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