Brexit – this is where the wheels come off: UK (and now Dutch) Notified Body BSi has advised that all UK issued CE certificates become invalid in case of no deal Brexit.

BSi, in a letter to its clients has confirmed advice from the UK and Netherlands Competent Authorities that in the event of a no deal Brexit at end of March, all CE certificates from UK Notified Bodies become invalid and product backed by these certificates will no longer be able to be supplied in Europe.

Similarly, the other UK Notified Bodies have provided various strategies:

• SGS has sister organisations in Belgium and Finland and has flagged the potential for transfer,
• LRQA is establishing a new Netherlands Notified Body but expects designation between June and September – leaving an obvious gap.
• UL (UK) has as its most recent advice a statement dated 2016 offering commitment to remain as a Notified Body but provides no further details on its website.

Urgent Action Required

So what can manufacturers do?

1. Urgently Migrate to a European Notified Body

This must be done before the 29 March Brexit date.  For BSi customers, there is the option of a transfer to the new BSi Netherlands Notified Body and BSi will attempt to expedite this process. For manufacturers certified with other UK Notified Bodies, it may be necessary to go to another Notified Body in absence of an “in-house” alternative.

2. Ensure contingency reserve stocks are placed on the market

Again this must be done before the 29 March Brexit date.  Placing on the market means being physically manufactured and entered into a European supply chain – e.g. by shipping to a Warehouse within the European Union (in any of the EU27 member states, not the UK).

Meanwhile, the UK Parliament continues to spin its wheels as the whole show approaches the “No Deal” clifftop.

MHRA Advice

The United Kingdom Competent Authority MHRA, without a hint of irony, provides its official position on its website under the headline “Making a Success of Brexit“.  This includes statements that the MHRA continues to supervise UK Notified Bodies and that “preparations to implement proposed new Regulations for Medical Devices and IVDs continue”.  This is all rather painfully starting to look like wishful thinking.

In a more helpful publication, MHRA advises on plans for a No Deal Brexit in a Further Guidance Note. This sets out transitional arrangements to ensure product can still be marketed in the UK.  But it’s silent on what is (or is not) possible in Europe.  The MHRA, after all, is focused on regulations in the UK.

Meanwhile in Europe

The rest of Europe is getting on with MDR/IVDR.  The MDR transition is looking ever more flexible and the IVD industry is waking up to the enormity of the change.  And EUDAMED is still lumbering along as a mega-IT project. But at least it’s all moving in the right direction.  See here for our recent update on progress.

Useful Links:

BSi Press release

BSi Brexit Medical devices page

MHRA Brexit advice