For domestic and foreign manufacturers and importers of active medical devices of risk class I, we offer conformity assessment according to NV No. 54/2015 on technical requirements for medical devices (Regulation (EC) (EU) 2017/745 of the European Parliament and of the Council) and relevant legislation, which apply to a specified product when it is placed on the market [§ 2 letter b) of Act No. 22/1997 Coll. and § 4 of Act No. 90/2016 Coll.].

 

The "Conformity Assessment of a Medical Device" certificate is the basis for issuing the "EU DECLARATION OF CONFORMITY" and marking the product with the CE conformity mark. According to the requirements of the contracting authority, we prepare documentation for the notification of a medical device at the State Institute for Drug Control pursuant to Act No. 268/2014 Coll., On medical devices, as amended.