Health Care

Our Health Care team provides advice on all issues relating to medical devices.

Miri­am Schuh

The medi­cal device indus­try is facing a para­digm shift in which the focus is no lon­ger sole­ly on spe­ci­fic medi­cal device legis­la­ti­on. Busi­ness play­ers need to keep pace with the regu­la­to­ry impact of the Euro­pean Green Deal and at the same time make the most of the oppor­tu­ni­ties pre­sen­ted by digi­ta­li­sa­ti­on and AI solutions.

The chall­enge

The Euro­pean Eco­no­mic Area is an attrac­ti­ve sales mar­ket and dis­tri­bu­ti­on tar­get for medi­cal devices and IVDs. The MDR and IVDR offer a stan­dar­di­sed set of regu­la­ti­ons that reflect the spe­cial requi­re­ments for medi­cal devices and IVDs. Howe­ver, the con­for­mi­ty of pro­ducts with the requi­re­ments of MDR and IVDR is only the obvious basis. Addi­tio­nal regu­la­to­ry requi­re­ments may also app­ly to medi­cal devices and IVDs. From deve­lo­p­ment and pro­duc­tion to pro­duct infor­ma­ti­on and labe­l­ing through to pack­a­ging and dis­po­sal, envi­ron­men­tal regu­la­ti­ons in par­ti­cu­lar must be hee­ded. Legis­la­ti­on as part of the Euro­pean Green Deal has signi­fi­cant­ly tigh­ten­ed exis­ting requi­re­ments or imple­men­ted new regu­la­ti­ons, inclu­ding the REACH Regu­la­ti­on (PFAS requi­re­ments), the RoHS Direc­ti­ve, the Ecode­sign Direc­ti­ve, the Green Claims Regu­la­ti­on, the Cor­po­ra­te Sus­taina­bi­li­ty Report­ing Direc­ti­ve, the Bat­tery Regu­la­ti­on and pack­a­ging regu­la­ti­ons, to name but a few. Digi­tal pro­ducts or tho­se with AI com­pon­ents must also ful­fil cyber­se­cu­ri­ty requi­re­ments and the requi­re­ments of the AI Regu­la­ti­on. By affi­xing the CE mark, manu­fac­tu­r­ers also decla­re con­for­mi­ty with the­se sup­ple­men­ta­ry or addi­tio­nal hori­zon­tal regulations.

Our focus: medi­cal devices

The regu­la­to­ry requi­re­ments for medi­cal devices and IVDs, inclu­ding digi­tal health appli­ca­ti­ons such as medi­cal apps, across the enti­re life cycle are com­plex and con­ti­nue to increase as regu­la­ti­on pro­gres­ses, even inde­pendent­ly of the MDR and IVDR. Manu­fac­tu­r­ers, but also importers, dis­tri­bu­tors and sup­pli­ers are requi­red to ensu­re the safe­ty and per­for­mance of their pro­ducts along the sup­p­ly chain. Our team offers sup­port with all legal issues rela­ting to medi­cal devices and IVDs. For more than ten years, we have been advi­sing eco­no­mic play­ers on the imple­men­ta­ti­on of a relia­ble com­pli­ance manage­ment sys­tem and offer prac­ti­ca­ble solu­ti­ons for com­mu­ni­ca­ti­on with one ano­ther as well as with Noti­fied Bodies and mar­ket sur­veil­lan­ce aut­ho­ri­ties – espe­ci­al­ly in the con­text of mar­ket mea­su­res and recall scenarios.

The team

Health Care

Anna Piroth

Seni­or Associate

Health Care

Miri­am Schuh

Head of Healthcare

Health Care

Saskia Wittbrodt


360° com­pli­ance for medi­cal devices – ana­lo­gue and digital

The reusch­law Health­ca­re Depart­ment advi­ses manu­fac­tu­r­ers of ana­lo­gue and digi­tal medi­cal devices and IVDs on the appli­ca­bi­li­ty of all product-specific Euro­pean regu­la­ti­ons with an impact on pro­duct com­pli­ance along the enti­re life cycle of the pro­ducts. Our “360° Com­pli­ance for Medi­cal Devices” con­sul­ting approach gives eco­no­mic play­ers a clear over­view of the obli­ga­ti­ons ari­sing for them from the respec­ti­ve regulations.

We sup­port our cli­ents in iden­ti­fy­ing gaps in the exis­ting sys­tem and thus reco­g­nis­ing pro­duct safe­ty risks and avo­i­ding lia­bi­li­ty risks. This appli­es in par­ti­cu­lar to regu­la­ti­ons that have been signi­fi­cant­ly tigh­ten­ed or new­ly imple­men­ted as part of the Euro­pean Green Deal. We are also available for the “audit-proof” draf­ting of con­tracts bet­ween stake­hol­ders, com­mu­ni­ca­ti­on with noti­fied bodies and FSCA and recall manage­ment in dia­lo­gue with the mar­ket sur­veil­lan­ce authorities.

For digi­tal pro­ducts or pro­ducts with AI com­pon­ents, we work with our expe­ri­en­ced Digi­tal Busi­ness Unit to advi­se on the appli­ca­ble cyber­se­cu­ri­ty requi­re­ments and the pro­vi­si­ons of the AI Regulation.

We also pro­vi­de sup­port with

  • Qua­li­fi­ca­ti­on and clas­si­fi­ca­ti­on of products;
  • Mar­king and labe­l­ing (CE and UKCA);
  • Eva­lua­ti­on of decla­ra­ti­ons of con­for­mi­ty, ins­truc­tions for use and mar­ke­ting materials;
  • Inclu­si­on of DiGA in the DiGA direc­to­ry (Fast Track Process);
  • Health and pati­ent data protection;
  • Roll-out of neces­sa­ry mar­ket mea­su­res and com­mu­ni­ca­ti­on with aut­ho­ri­ties and cus­to­mers in worst-case scenarios.


Medical Devices - 360° Compliance (english)

Medi­cal Devices – 360° Com­pli­ance (eng­lish)

Medical Devices - 360° Compliance (chinese)

Medi­cal Devices – 360° Com­pli­ance (chi­ne­se)

Medical Devices - 360° Compliance (japanese)

Medi­cal Devices – 360° Com­pli­ance (japa­ne­se)

Medical Devices - 360° Compliance (korean)

Medi­cal Devices – 360° Com­pli­ance (kore­an)

Medical Devices - 360° Compliance (german)

Medi­cal Devices – 360° Com­pli­ance (ger­man)

We help our cli­ents with all legal issues rela­ting to medi­cal devices throug­hout their enti­re life cycle. Natio­nal­ly and inter­na­tio­nal­ly. Cont­act us!

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