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Health Care

Miri­am Schuh

Our focus: Medi­cal devices

The regu­la­to­ry requi­re­ments for the deve­lo­p­ment, pro­duc­tion, mar­ke­ting and moni­to­ring of clas­sic medi­cal devices inclu­ding in-vitro dia­gnostics as well as digi­tal health app­li­ca­ti­ons such as medi­cal apps are com­plex and have been inten­si­fied sin­ce the Euro­pean Medi­cal Devices and In-vitro Dia­gnostics Regu­la­ti­on came into for­ce. Manu­fac­tu­rers, as well as importers, dis­tri­bu­tors and sup­pliers, are requi­red to ensu­re the safe­ty and per­for­mance of their pro­ducts throughout the sup­ply chain. Our team offers sup­port in all legal ques­ti­ons rela­ting to the Euro­pean MDR and IVDR regu­la­ti­ons as well as natio­nal legis­la­ti­on. We advi­se indus­try play­ers on the imple­men­ta­ti­on of resi­li­ent com­pli­an­ce manage­ment sys­tems, offe­ring workab­le solu­ti­ons for com­mu­ni­ca­ti­on with noti­fied bodies and mar­ket sur­veil­lan­ce aut­ho­ri­ties, espe­cial­ly with respect to mar­ket mea­su­res and recall scenarios.

Our Health­ca­re team has been ser­ving and advi­sing indus­try play­ers for over a deca­de and has exten­si­ve exper­ti­se in sup­por­ting manu­fac­tu­rers, dis­tri­bu­tors and sup­pliers of both ana­log and digi­tal medi­cal devices. Our sup­port ran­ges from the draf­ting of legal­ly com­pli­ant con­tracts to the imple­men­ta­ti­on of com­plex com­pli­an­ce manage­ment sys­tems and cri­sis manage­ment in worst-case scenarios.

Team

Saskia Witt­brodt

Saskia Witt­brodt

Seni­or Associate 

Jen­ni­fer Stauder

Jen­ni­fer Stauder

Asso­cia­te

Karin Potel

Karin Potel

Asso­cia­te

Anna Piroth

Anna Piroth

Asso­cia­te

Sebas­ti­an Giera

Sebas­ti­an Giera

Of Coun­sel

Niklas Gater­mann

Niklas Gater­mann

Seni­or Associate

Thors­ten Deeg

Thors­ten Deeg

Seni­or Associate

Chris­toph Callewaert

Chris­toph Callewaert

Asso­cia­te

Ste­fan Hessel

Ste­fan Hessel

Head of Digi­tal Business

Miri­am Schuh

Miri­am Schuh

Head of Healthcare

Dani­el Wuhrmann

Dani­el Wuhrmann

Head of Mobility

Phil­ipp Reusch

Phil­ipp Reusch

Head of Regu­la­to­ry Affairs & Mar­ket Measures 

The all-round care­free con­sul­ting package

The Health Care Depart­ment advi­ses manu­fac­tu­rers of medi­cal devices on legal issu­es rela­ting to the Euro­pean MDR and IVDR regu­la­ti­ons, but also on the mul­ti­tu­de of natio­nal regu­la­ti­ons. Fur­ther­mo­re, we support:

  • the qua­li­fi­ca­ti­on and clas­si­fi­ca­ti­on of pro­ducts (“genui­ne” medi­cal devices vs. con­su­mer pro­ducts, “genui­ne” DiGaV-capable medi­cal apps vs. well­ness apps) and resul­ting deman­ds for qua­li­ty and risk manage­ment systems.
  • the draf­ting of legal­ly secu­re con­tracts with deve­lo­p­ment ser­vice pro­vi­ders, sup­pliers and dis­tri­bu­tors that com­ply with both legal and regu­la­to­ry requi­re­ments and the con­tent of the industry-standard DIN ISO 13485, hol­ding up to the scru­ti­ny of noti­fied bodies and mar­ket regu­la­to­ry authorities.
  • the imple­men­ta­ti­on and review of com­pli­an­ce manage­ment sys­tems through which manu­fac­tu­rers can iden­ti­fy gaps in exis­ting sys­tems and thus iden­ti­fy pro­duct safe­ty risks and avoid lia­bi­li­ty risks.
  • the eva­lua­ti­on of decla­ra­ti­ons of con­for­mi­ty, user infor­ma­ti­on and mar­ke­ting mate­ri­als for pro­ducts in order to pro­tect against actions and warnings.
  • the roll-out of necessa­ry mar­ket mea­su­res and com­mu­ni­ca­ti­on with aut­ho­ri­ties and cus­to­mers in worst-case sce­n­a­ri­os trig­ge­red by unsafe medi­cal devices.
  • the incre­a­singly com­plex issu­es sur­roun­ding health data pro­tec­tion and cyber­se­cu­ri­ty with the expe­ri­en­ced  Digi­tal Busi­ness Unit team at our disposal.

We assist our cli­ents in all legal issu­es rela­ting to medi­cal devices. From deve­lo­p­ment to moni­to­ring. Natio­nal­ly and inter­na­tio­nal­ly. Con­ta­ct us!

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