Factsheet for Healthcare Professionals and Health Institutions

Factsheet for Healthcare Professionals and Health Institutions

The European Commission released a “Factsheet for Healthcare Professionals and Health Institutions” explaining what European professionals needs to know about the new Medical Device Regulation:

The MDR allows reprocessing of single-use MDs to enable their safe re-use, as long as this is also permitted by national law and only in accordance with MDR Article 17. A reprocessor would assume all the responsibilities of the original manufacturer of this device (MDR Article 17(2)), but Member States may decide to relax this rule somewhat for devices that are reprocessed and used within a health institution (MDR Article 17(3)) or reprocessed by a third party at the request of a health institution (MDR Article 17(4)). In these cases the safety and performance of the reprocessed device must be equivalent to that of the original, and systems must be in place for risk management, process validation, performance testing, quality management, incident reporting and traceability…

To read more, click HERE.

 

By |2019-07-03T17:55:19+00:00July 3rd, 2019|In the Press|0 Comments