The Association of Medical Device Reprocessors (AMDR) appreciates the opportunity to
comment on the Slovenian Ministry of Health public consultation on its implementation
of the Regulation (EU) on medical devices. AMDR provides comment on section II.
PROCESSING OF DEVICES AND INFORMATION REGARDING IMPLEMENTED DEVICES,
Article 8 (disposable devices and their reprocessing): 070-110/2019
Article 17 of the European Union’s Medical Device Regulation (MDR) of 2017 puts in
place stringent new EU-wide requirements for the reuse of “single-use” devices (SUDs).
EU Member States have discretion on which path or paths to take, as outlined in the
provisions of article 17, and the EU MDR is to be fully implemented by May of this year
(2021). In short, any reuse of SUDs must both adhere to the safety and efficacy
requirements of the MDR and be allowed by national provision. The safety and
regulatory requirements require that that reprocessor adhere to the same standards as
applied to original equipment manufacturers and obtain a CE mark – often dubbed in
Europe, “remanufacturing of SUDs.” Or, Member States may elect to allow hospitals to
reuse SUDs so long as it is compliant with the European Commission’s 2020 “Common
Specifications.” . . .
View AMDR’s comments HERE.