With 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?”
The political landscape is far from clear. However, BSI would concur with the recent MHRA paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing will change during the implementation period to 31st December 2020.
Netherlands – BSI Designation
There is much discussion and we are very pleased to confirm BSI is almost complete in our MDD /AIMD application with a target date we are working towards agreed between BSI NL and IGJ of Q3 2018 for MDD/AIMD designation.
With this in mind, if driven by a “non-negotiated” or “hard” Brexit outcome, there is a need to rapidly migrate CE certificates to the Netherlands. We have a relatively straightforward process (this does not require additional conformity assessment) agreed and the plan is resourced to deliver the change within the required timeframe. We have shared this information with our clients around the globe.
If there is a non-negotiated Brexit outcome resulting in the need to migrate all certificates to the new NL NB, the advice we have received from IGJ (NL Healthcare Inspectorate), NL Ministry of Health and the EU Commission, is that a new NB number relating to our NL designation is required and it is not possible to retain our existing NB 0086 number. (BSI does however plan to retain the existing certificate number).
Whilst this raises the spectrum of potentially requiring additional resources for relabelling, BSI can confirm that the relabelling requirements normally associated with transfer from other EU Notified Bodies can justifiably be prolonged (NBOG BPG 2006-01). This has been discussed with the Designating Authority in both our initial designation Joint Assessment and recent follow-up Joint Assessment.
The underlying rationale for allowing this is that there is no deleterious direct or indirect impact on patient safety as a result of the “listing in NANDO … as NB00NL (also ex NB 0086) so that the reference of the old NB can still be found.” This full traceability means that “manufacturers don’t need to relabel products which have already been placed on the market to refer to the new NB number, since the old number can still be traced in NANDO”.
This approach, in effect, means that relabelling would need to be planned, implemented and audited in continuing assessment visits taking into account the agreed justified extended timelines.
Finally, as time is ticking, we advise companies to engage with NBs and consider their next steps to ensure continued market access in the years ahead.