Medical Devices Ordinance
(MedDO)

¹ Man­u­fac­tur­ers must have avail­able with­in their or­gan­isa­tion at least one per­son re­spons­ible for reg­u­lat­ory com­pli­ance who pos­sesses the re­quis­ite ex­pert­ise in the field of med­ic­al devices.

² Proof that the per­son re­spons­ible for reg­u­lat­ory com­pli­ance pos­sesses the re­quis­ite ex­pert­ise, the re­spons­ib­il­it­ies of this per­son, ex­cep­tions and fur­ther mod­al­it­ies are gov­erned by Art­icle 15 EU-MDR⁸⁶.

³ The per­son re­spons­ible for reg­u­lat­ory com­pli­ance must have a deputy. If a num­ber of per­sons are jointly re­spons­ible for reg­u­lat­ory com­pli­ance, their re­spect­ive areas of re­spons­ib­il­ity shall be stip­u­lated in writ­ing.

⁴ The per­son re­spons­ible for reg­u­lat­ory com­pli­ance must suf­fer no dis­ad­vant­age with­in the man­u­fac­turer's or­gan­isa­tion in re­la­tion to the prop­er ful­fil­ment of his or her du­ties, re­gard­less of wheth­er or not they are em­ploy­ees of the or­gan­isa­tion.