IMDRF meeting
held by Commission on August 26th : 3 Team-NB representatives were present.
Scrip Regulatory Affairs “Two EU notified bodies join international pilot to test common submission format for devices”
2 Notified bodies joined a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions.
Clinica “EU notified body numbers still yet to bottom out “
NB withdrawals are due to three reasons, she said: not being able to conform to new regulations; following a joint assessment or competent authority audit; and/or mergers of NBs.
Michael Bothe presented
a conference on the theme of unannounced audits in Frankfurt
The Council agreed
the substance on 2 Medical Devices draft regulations with a mandate to start talks with the European Parliament with a view to reach an agreement as early as possible.
Team-NB has reorganized
its website to increase functionality and make it easier to navigate.
In the framework of NB transfer agreement
you will find information concerning the contact data person and/or department to get one contact email in each NB member to help the other NB to get directly with the adequate person.
An article in Scrip Regulatory Affairs by Vibha Sharma :
Underperformance of EU medtech industry overseers pinpointed in joint assessment initiative.
Important Information
on revamp of Medical Devices section of the Commission website. Due to the reorganisation of EU Commission services the website on Medical Devices was moved from DG SANCO (now DG SANTE) to the website of DG GROW at the beginning of this year. Please note that the website on medical devices has now been revamped. [...]