MedTech Europe Encouraged by Council Discussions
...It is apparent that Council found it important to make progress on discussions to achieve a balanced regulation for medical devices and in vitro diagnostics. But at the same time a significant number of Member
A win for the reprocessing industry today! U.S. Supreme Court rules in favor of Impression Products, Inc.
AMDR is thrilled to announce that our efforts at the U.S. Supreme Court – where we joined advocacy groups, non-profits and many leading technology companies and filed an amicus curiae brief in support of Impression
AMDR’s Dan Vukelich talks EU MDR in the May issue of the Journal of Medical Device Regulation
The May issue of the Journal of Medical Device Regulation, a peer-reviewed journal from the UK, recently covered the new EU Medical Devices Regulation in an article by AMDR’s Dan Vukelich. “How will the new
AMDR Participates in AAMI’s Sustainability Efforts
AMDR participated yesterday in AAMI’s Sustainability Committee meeting held in Minneapolis in conjunction with CleanMed 2017. The Committee is re-evaluating the existing Technical Information Report (TIR) on sustainability of medical devices – elements of a
SUD Reprocessing, AMDR Featured at EORNA 2017
Just recently convened, last week’s 8th Annual gathering of Europe’s operating room nurses – known as EORNA 2017 – included in the program a discussion of the new European Medical Devices Regulations as they pertain
European Union, Medical Device Regulation of 2017, Regulation (EU) 2017/745 of the Euroepan Parliament and of the Council 5 April 2017, Article 17:
Single-Use Devices and their Reprocessing “…The reprocessing and further use of single-use devices should only take place where permitted by national law and while complying with the requirements laid down in this Regulation. The reprocessor