Health Care

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.

Anna Piroth

Asso­cia­te

• T + 49 30 / 2332 895 0 
• E anna.piroth@reuschlaw.de

Miri­am Schuh

Head of Healthcare

• T +49 681 / 859 160 0 
• E miriam.schuh@reuschlaw.de

Saskia Witt­brodt

Seni­or Associate 

• T + 49 30 / 2332 895 0 
• E saskia.wittbrodt@reuschlaw.de

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!