Team NB, The European Association of Notified Bodies, released a summary of the Medical Device Sector survey. It gives insight into the number and types of CE and ISO certificates issued or withdrawn for Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Medical Devices in 2016. Team NB assembles 22 European Notified Bodies, such as (among others): TUV, SGS or BSI.
New European medical device regulation 2017/745 installs new 'no-grandfathering' rule to encourage conformity assessment and compliance throughout EU market.
Discover the list and scope of new devices covered by EU in-vitro diagnostics device regulation 2017/746, in effect from April 2017.
Given new importance by the upcoming EU regulations, the EUDAMED database will provide vital info to industry bodies on medical devices in Europe.
Learn more about the added roles and responsibilities of medical and in-vitro diagnostic device manufacturers under new EU regulations 2017/745 and 2017/746.
Working with a notified body is a mandatory obligation under the EU new approach directives. But how do you select the right one for your devices? We can help.
The new EU IVD regulation changed the classification system for in-vitro diagnostic devices in Europe. Learn more about the new risk-assessment based model.
Obelis Group exhibited for the 13th consecutive year at Medica Trade Fair, one of the…
A new series of regulatory and compliance guidelines for Original Brand Labelers working with medical and in-vitro diagnostic devices have been introduced.
Obelis Group will hold an EROMED seminar at the MEDICA trade show, taking place from the 14th November till 17th November in Messe Düsseldorf, in Germany. The seminar, which is entirely free of charge, will be conducted at the Obelis booth (Hall 17, Stand D59), every day at 11 am and 3 pm. It will focus on the new proposal on EU legislation on Medical Devices and its impact on the compliance path and the CE marking process.