Medical Devices Ordinance
(MedDO)

¹ An es­tab­lish­ment li­cence is­sued by Swiss­med­ic is re­quired for any nat­ur­al or leg­al per­son who:

a.

re­moves tis­sues or cells from hu­mans for the pur­pose of de­vi­tal­ising the tis­sues or cells and us­ing them to man­u­fac­ture devices or sup­ply­ing them for use in device man­u­fac­ture;

b.

stores tis­sues or cells col­lec­ted for the pur­poses in let­ter a;

c.

im­ports or ex­ports tis­sues or cells col­lec­ted for the pur­poses in let­ter a.

² A li­cence shall be is­sued if:

a.

the re­quire­ments in terms of pro­fes­sion­al qual­i­fic­a­tions and op­er­a­tion­al in­fra­struc­ture are ful­filled;

b.

a qual­ity as­sur­ance sys­tem that com­plies with cur­rent sci­entif­ic and tech­no­lo­gic­al stand­ards is in place;

c.

the fa­cil­ity has a Re­spons­ible Per­son with the ne­ces­sary spe­cial­ized know­ledge, ex­per­i­ence and dir­ect­ive au­thor­ity in their area of activ­ity and who is re­spons­ible for qual­ity;

d.

the ob­lig­a­tions spe­cified in Art­icles 31 and 32 are ful­filled.

³ Swiss­med­ic shall veri­fy that the con­di­tions for is­su­ing an es­tab­lish­ment li­cence are ful­filled in the course of an in­spec­tion.

⁴ Art­icles 39–43 of the Medi­cin­al Products Li­cens­ing Or­din­ance of 14 Novem­ber 2018⁷² (MPLO) also ap­ply mu­tatis mutandis.