CE marking related to the registration medical devices in Europe.
borderline and classification medical devices: UPDATED MANUAL ON BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES Version 1.16 (07-2014) Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable…
Having visitors is not always a pleasure. On top of that some of them have the right to step in. So it’s better to be prepared for that situation and deal with it no matter what happens. How do you deal with Notified Body Unannounced Audits announced to be taking place soon (if not already)…
May 16, 2014: the list of harmonized standards for the medical devices directive is updated. It’s been more than one year since this list was updated. Last time was Jan. 24, 2014. So what’s the change ? Since it is very hard to figure out just by reading the publication on the Official Journal of…
Manufacturers of medical devices in Europe won’t need to change their labeling. Initially EN 980:2008 was about to be replaced by EN ISO 15223-1:2012 but as stated by the European Commission that won’t be the case. Some people were surprised seeing that no standard related to symbols was addressed anymore in the list of harmonized…