Does the Pro­duct Safe­ty Regu­la­ti­on app­ly to medi­cal devices?

All medi­cal devices in the EU are sub­ject to the Medi­cal Device Regu­la­ti­on. Accor­din­gly, many have argued that other Euro­pean regu­la­ti­ons do not app­ly to medi­cal devices and to eco­no­mic ope­ra­tors in the health care sec­tor. That is fal­se. In addi­ti­on to the MDR, which con­ta­ins rules for this sec­tor spe­ci­fi­cal­ly, a num­ber of inter-sector “hori­zon­tal” regu­la­ti­ons must also be hee­ded (e.g. the future AI Act, the future Cor­po­ra­te Sus­taina­bi­li­ty Report­ing Direc­ti­ve and the NIS‑2 Directive).

This is also the case for the new EU Gene­ral Pro­duct Safe­ty Regu­la­ti­on (GPSR) which replaces Direc­ti­ve 2001/95/EC on gene­ral pro­duct safe­ty and which is appli­ca­ble to all con­su­mer pro­ducts, inclu­ding medi­cal devices. The pro­vi­si­ons of the GPSR app­ly unless a more spe­ci­fic pro­vi­si­on can be found in the MDR.

“Ful­film­ent ser­vice providers”

This is the case e.g. with regard to “ful­film­ent ser­vice pro­vi­ders,” which are not men­tio­ned in the MDR and which are defi­ned in the GPSR as someone “offe­ring, in the cour­se of com­mer­cial acti­vi­ty, at least two of the fol­lo­wing ser­vices: warehousing, pack­a­ging, addres­sing and dis­patching, wit­hout having owner­ship of the pro­ducts invol­ved, exclu­ding pos­tal ser­vices … , par­cel deli­very ser­vices … , and any other pos­tal ser­vices or freight trans­port ser­vices.” Ful­film­ent ser­vice pro­vi­ders qua­li­fy as eco­no­mic ope­ra­tors in terms of the Pro­duct Safe­ty Regu­la­ti­on, along­side manu­fac­tu­r­ers, aut­ho­ri­sed repre­sen­ta­ti­ves, importers and dis­tri­bu­tors. Ful­film­ent ser­vices which invol­ve medi­cal devices will the­r­e­fo­re be sub­ject to both the MDR and the Gene­ral Pro­duct Safe­ty Regu­la­ti­on in the future.

“Online mar­ket­places”

Online sales of con­su­mer pro­ducts will also be sub­ject to a sin­gle set of Euro­pean regu­la­ti­ons with the adop­ti­on of the Gene­ral Pro­duct Safe­ty Regu­la­ti­on. The MDR alre­a­dy con­ta­ins legal obli­ga­ti­ons for dis­tri­bu­tors of medi­cal devices, as well as requi­re­ments for distance sel­ling. The Gene­ral Pro­duct Safe­ty Regu­la­ti­on also defi­nes the terms “online mar­ket­place” and “online inter­face,” crea­ting legal cer­tain­ty in this regard. In addi­ti­on, Chap­ter IV of the Gene­ral Pro­duct Safe­ty Regu­la­ti­on deals expli­cit­ly with sales through online mar­ket­places and Artic­le 20 of the Regu­la­ti­on estab­lishes spe­ci­fic obli­ga­ti­ons for online mar­ket­places with regard to pro­duct safe­ty, which are for­mu­la­ted in a depth which can­not be found in the MDR.

Recom­men­ded actions

Eco­no­mic ope­ra­tors which place medi­cal devices on the mar­ket as con­su­mer pro­ducts will be sub­ject not only to the Medi­cal Device Regu­la­ti­on but to the EU Gene­ral Pro­duct Safe­ty Regu­la­ti­on as well. Par­ti­cu­lar­ly ful­film­ent ser­vice pro­vi­ders, ope­ra­tors of online mar­ket­places and tho­se enga­ged in online sel­ling need to fami­lia­ri­ze them­sel­ves with the con­tent of the Gene­ral Pro­duct Safe­ty Regu­la­ti­on and imple­ment its pro­vi­si­ons so as to ensu­re that their dis­tri­bu­ti­on acti­vi­ties con­form to regu­la­ti­ons. We can pro­vi­de assis­tance when it comes to iden­ti­fy­ing the requi­re­ments which app­ly in each case and imple­men­ting tho­se requi­re­ments in a legal­ly cer­tain man­ner. Plea­se let us know if we can help you in this regard.


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