The Plenary session of the European Parliament just adopted the two texts on Medical Devices and In Vitro. There were for each text only one amendment tabled by Nigel Farage and the UKIP, asking to [...]
He presented the concerns Notified Bodies have on the implementation of the new regulations. During an extensive round of discussion various obstacles and unclear requirements and possible options to overcome such interesting challenges were discussed.
The topic of the entire day was the implementation of the new MDR and the impact to their members. Hans-Heiner Junker provided a speech on two topics: Impact on Technical Documentation and Impact on [...]
On October 11th general assembly meeting, Team-NB decided to suspend the audits against the Code of Conduct in order to work on the preparation of interpretations on MDR requirements in an objective of harmonisation.