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Conformity assessment of medical device

For the import and sale of medical device, it is necessary to pass procedure for conformity assessment according local Technical Regulations. Depending on the type of medical devices, they should be assessed for compliance with one of the Technical regulation:

  • Technical regulations for the general group of medical devices (Resolution of the Cabinet of Ministers No. 753 of October 2, 2013);
  • Technical regulations for in vitro medical devices diagnostics (Resolution of the Cabinet of Ministers No. 754 of 02.10.13);
  • Technical regulations for active implantable medical devices (Resolution of the Cabinet of Ministers No. 755 of 02.10.13).

Depends of the risk class and product characteristics, there are several types of conformity assessment procedures:

  • self-declaration (medical products of I safety class, not sterile, without measurement function; in vitro diagnostics list “other”);
  • audit of a legal manufacturer (sterile products, products of Im, IIa, IIb and III safety classes; in vitro diagnostics list A and B; active implantable device);
  • by-batch procedure (non-sterile products classes Im, IIa, IIb);
  • type examination  (products for self-control);
  • recognition of the results of work obtain by a European notify body (sterile products, products IIa, IIb and III safety classes; in vitro diagnostics list A and B; active implantable devices, agreement between notify body from EU and Ukraine required).

Medical device can also be included in the scope of other technical regulations, for example:

  • RED (Technical regulation of radioequipment DCMU #355)
  • TR 94 (Technical Regulations of Legally Regulated Means of Measuring Technique – DCMU #94)
  • ROHS (Technical Regulations on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment – DCMU #139)

The Archimedes company offers you its assistance in supporting compliance assessment with technical regulations.

Recognition of the results of work of the European notify body

Conformity assessment in notify body

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Conformity assessment without involvement of the designated authority

Selfdeclaration

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Conformity assessment by audit
of legal manufacturer

Conformity assessment in notify body

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RoHS (DCMU 139)

Technical Regulations for the Restriction of Use of Certain Hazardous Substances in Electrical and Electronic Equipment

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Metrology (DCMU 94)

Technical regulations for legally regulated measurement instruments

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RED (DCMU 355)

Technical regulations radioequipment

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