BREXIT - What/How are You and Your Business Preparing for It?

F

fialor

Involved In Discussions
We are just over 7 months till the end of the article 50 notice period that the UK gave to the EU. Come 00:00h on the 30th of March 2019 (midnight 29th of March 2019) the UK would have Withdrawn from the EU.

The best case scenario is that we have a withdrawal agreement in place that would support a calm transition, a mutual recognition agreement that would all trade to continue almost uninterrupted, and some free movement for goods, if not people.

The worse case scenario is that there is no deal and we end up, fully Withdrawn with no support/transition system come the 30th of March 2019.

From what I can see the main areas most economic operators but especially manufacturers based in the EU have to address/plan for are:
  • no EU member state so would 3rd party and must comply with 3rd party rules
  • will require AR in the EU 27
  • most manufacturers in the UK have UK NBs, meaning new NBs from the EU 27 will be required
  • most UK NBs are of course planning/going through certification in other EU 27 member states so they can retain NB status in the EU
  • all current distribitors in the EU for the UK manufacturer will now be EU importers and therefore must compy with EU requirements. The manufacturer will also require new importer contracts rather than distributor ones. The MDR will of course also complicate this further.

Question
What are you doing to prepare for BREXIT, even if the politicians continue to bury their heads in quick sand!
  • EU Manufacturer with distributors in the UK
  • EU distributor of a UK manufacturer
  • UK manufacturer with its factories in the EU 27
  • UK Manufacturer with its UK NB
  • EU 27 manufacturer with UK NB
  • EU manufacturer with UK NB
 
Sidney Vianna

Sidney Vianna

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I have no answer for you, but started wondering about the conformity assessment bodies in the UK, especially the Notified Bodies which are regulated. Will their services be impacted or affected? If so, how?
 
M

Marcelo

Inactive Registered Visitor
I've been suggesting that my clients have a backup plan to change AR/NB to mainland Europe, and that they should implement the plan (including moving, if they feel necessary) as quickly as possible.

The fact is, although UK/MHRA is trying to be optimistic about this, my gut feeling is that it's going down the hill. And for several businesses, it's too much of a risk to be depending on so much uncertainty.

Also, it's not a good time for the MedDev field due to the transition, which makes the uncertainty grows exponentially.

So, if we think that we have "uncertainty in Brexit".cost + "uncertainty in transition".cost + "other uncertainties".cost = "a lot of uncertainty".cost, it seems to me that removing the brexit part (with the related cost, obviously) seems like a safer bet now (but it surely needs a more deep cost x benefit analysis than my quick example above :p).
 
Sidney Vianna

Sidney Vianna

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Marcelo Antunes said:
The fact is, although UK/MHRA is trying to be optimistic about this, my gut feeling is that it's going down the hill. And for several business, it's too much of a risk to be depending on so much uncertainty.
Click to expand...
Interesting analysis, Marcelo. I sense there is no love lost between the EU member countries and the UK and there will be very little good will by authorities in the EU for "acceptance" and grace periods. Another business/commercial risk for manufacturers of regulated products to deal with, especially when NB's are already stretched for resources.

Who knows? Maybe a merger or acquisition by an NB from the continent would be in order....:notme:
 
T

tyker

Marcelo Antunes said:
I've been suggesting that my clients have a backup plan to change AR/NB to mainland Europe, and that they should implement the plan (including moving, if they feel necessary) as quickly as possible.
).
Click to expand...

What advice are you giving to your clients with their AR/NB in mainland Europe who want to continue doing business in the UK after Brexit?
 
M

Marcelo

Inactive Registered Visitor
tyker said:
What advice are you giving to your clients with their AR/NB in mainland Europe who want to continue doing business in the UK after Brexit?
Click to expand...

These have, in general, some more space to breath (in comparison to the ones which have their AR/NB, because for these latter ones , but a plan need to be created anyway). I'm suggestion more or less these steps (again, I'm writing this in a simplistic way):

- To review their business strategy in the UK and check how much of their revenue comes from the UK

- If the revenue from the UK is low (which is true for most of my clients in Brazil), to wait for some more decisions (to lower the uncertainty) regarding the UK continuing to use the directives/regulation or to create their own system. This will probably be done until the end of the year, hopefully, so at the end of the year, the plan has to be revised

- If the UK continues to use CE marking, continue do include the UK in the plan that is being done for CE marking in general

- If the UK creates another system, review revenue, estimate the investment to pursue this new system, and calculate the ROI. If the ROI is not enough, consider leaving the UK market. If the ROI is enough, plan on pursuing the new system.

- In any case, continue with the general CE marking plan
 
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