Weara­bles in medicine

Oppor­tu­ni­ties, risks and regu­la­to­ry requirements

• Medi­cal Device Regu­la­ti­on (MDR)

Medi­cal weara­bles used to dia­gno­se or tre­at dise­a­ses are sub­ject to the requi­re­ments of the Medi­cal Device Regu­la­ti­on (MDR). This places high demands on safe­ty, per­for­mance and cli­ni­cal evi­dence. Manu­fac­tu­r­ers must pro­ve that their pro­ducts func­tion relia­bly and pose no health risks.

• Dif­fe­ren­tia­ti­on from con­su­mer wearables

The distinc­tion bet­ween simp­le fit­ness tra­ckers and medi­cal devices is not always clear. The manu­fac­tu­rer’s inten­ded pur­po­se and the actu­al use are decisi­ve. A weara­ble that only records gene­ral fit­ness data is not con­side­red a medi­cal device. Howe­ver, as soon as it sup­ports medi­cal dia­gno­ses or inter­ven­es in the­ra­py pro­ces­ses, the MDR regu­la­ti­ons apply.

• Data pro­tec­tion and IT security

Medi­cal weara­bles pro­cess par­ti­cu­lar­ly sen­si­ti­ve health data. The Gene­ral Data Pro­tec­tion Regu­la­ti­on (GDPR) obli­ga­tes manu­fac­tu­r­ers and pro­vi­ders to gua­ran­tee the hig­hest secu­ri­ty stan­dards. This includes the encryp­ti­on of data trans­mis­si­on, access con­trols and trans­pa­rent data pro­tec­tion guidelines.

Imple­men­ta­ti­on and main­ten­an­ce of a Pro­duct Com­pli­ance Manage­ment Sys­tem (PCMS)

The regu­la­to­ry requi­re­ments for weara­bles, par­ti­cu­lar­ly in the medi­cal sec­tor, are the­r­e­fo­re high. Manu­fac­tu­r­ers must ensu­re that their pro­ducts com­ply with the appli­ca­ble legal requi­re­ments in order to gua­ran­tee mar­ket access, pro­duct safe­ty and con­su­mer pro­tec­tion. A struc­tu­red Pro­duct Com­pli­ance Manage­ment Sys­tem (PCMS) helps com­pa­nies to sys­te­ma­ti­cal­ly meet the­se chal­lenges and mini­mi­se legal risks.

An effec­ti­ve PCMS for weara­bles should include the fol­lo­wing elements:

• Regu­la­to­ry ana­ly­sis and risk assessment: 
  • Iden­ti­fi­ca­ti­on of rele­vant laws, stan­dards and cer­ti­fi­ca­ti­on requirements
  • Car­ry­ing out regu­lar risk assess­ments with regard to com­pli­ance risks
• Pro­duct deve­lo­p­ment and appr­oval processes
  • Ear­ly inte­gra­ti­on of regu­la­to­ry requi­re­ments into the deve­lo­p­ment process
  • Docu­men­ta­ti­on of pro­duct con­for­mi­ty through tech­ni­cal dossiers
  • Vali­da­ti­on of com­pli­ance through inter­nal audits and exter­nal certifications
• Data and cyber­se­cu­ri­ty measures
  • Imple­men­ta­ti­on of data pro­tec­tion by design and secu­ri­ty by design principles
  • Regu­lar secu­ri­ty updates and pro­tec­ti­ve mea­su­res against cyberattacks
• Pro­duct label­ling and documentation
  • Pro­vi­si­on of com­ple­te and com­pli­ant pro­duct labelling
  • Crea­ti­on and main­ten­an­ce of ope­ra­ting ins­truc­tions and tech­ni­cal documentation
• Moni­to­ring and con­ti­nuous improvement
  • Imple­men­ta­ti­on of a sys­tem for mar­ket sur­veil­lan­ce and report­ing of safe­ty incidents
  • Regu­lar employee trai­ning on new regu­la­to­ry developments
  • Inte­gra­ti­on of a com­plaints manage­ment sys­tem for the con­ti­nuous impro­ve­ment of pro­duct quality

Con­clu­si­on

Manu­fac­tu­r­ers of weara­bles should estab­lish a pro­duct com­pli­ance manage­ment sys­tem as an inte­gral part of their cor­po­ra­te stra­tegy. In view of the incre­asing regu­la­to­ry requi­re­ments, a struc­tu­red PCMS can not only mini­mi­se legal risks but also crea­te com­pe­ti­ti­ve advan­ta­ges and streng­then con­su­mer con­fi­dence. Con­ti­nuous review and adapt­a­ti­on of the sys­tem is essen­ti­al in order to be able to respond to new regu­la­to­ry deve­lo­p­ments and tech­no­lo­gi­cal advances.