All LRQA clients have been informed directly, and LRQA is working with the MHRA to help the transfer of companies to an alternative provider.
As the number of NBs continues to shrink, last week the European Commission issued a new communication on the “State of play of preparations" as to the UK's departure from the European Union, which included an update on the notified body situation (see page 5).
The Commission acknowledged that significant work will still be required to achieve full compliance by 31 October 2019, but believes that the extension of the Article 50(3) (UK withdrawal) until this date provides sufficient time to complete both the transfer of certificates and the adaptation of product labels.
FDA releases final version of Q-Sub guidance
7 May 2019
The US Food and Drug Administration (FDA) has published the final version of its guidance document titled 'Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program', superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of interaction with the Agency:
A. Pre-Submissions (Pre-Subs)
B. Submission Issue Requests (SIRs)
C. Study Risk Determinations
D. Informational Meetings
E. Other Q-Submission Types
The guidance also explains which interactions are not within the Q-Submission Program, and provides information on the Q-Sub process and the recommended content of Q-Sub submissions, dependant on the type of Q-Sub..