Medical Devices Ordinance
(MedDO)

¹ Labor­at­or­ies that wish to be des­ig­nated an ex­pert labor­at­ory by the European Com­mis­sion in ac­cord­ance with Art­icle 106 para­graph 7 EU-MDR⁹² may ap­ply to Swiss­med­ic for des­ig­na­tion.

² They must demon­strate to Swiss­med­ic in par­tic­u­lar that they:

a.

meet the cri­ter­ia set out in Art­icle 106 para­graph 8 EU-MDR; and

b.

are able to as­sume the tasks un­der Art­icle 106 para­graph 10 EU-MDR, tak­ing ac­count of the amend­ments to this pro­vi­sion ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts⁹³, in ac­cord­ance with the re­quire­ments in each case.

³ They must op­er­ate in one of the fol­low­ing fields:

a.

physico-chem­ic­al char­ac­ter­isa­tion;

b.

mi­cro­bi­o­lo­gic­al, mech­an­ic­al, elec­tric­al, elec­tron­ic or non-clin­ic­al bio­lo­gic­al and tox­ic­o­lo­gic­al test­ing or biocom­pat­ib­il­ity test­ing.

⁴ If the re­quire­ments are met, Swiss­med­ic will pro­pose to the EU Com­mis­sion that the labor­at­ory be des­ig­nated an ex­pert labor­at­ory.