As originally asked by Ewan Savage.

Julie O.
I don’t think the conclusion follows that barriers to entry will be lower.

Martin Dewey
What’s a ‘Wave 1 country’ when it’s at home..?

Hannah Sampson
Surely most companies selling into the EU will still have to adhere to the MDR? I cant imagine EU customers being happy with UK suppliers not adhering to this. Brexit needs to make the industry, laws and regulations move forward and not stay behind the times.

Bruce Ketcheson
UK suppliers and developers will have to be compliant to the regions they market in, before or after Brexit. Suggesting the U.K. will have a lower barrier to entry only means the U.K. will attract higher risk device submissions as they are seen as a lower bar, and often ‘designing out the issues’ kind of market.

Keili Lawrence
I don’t agree. MHRA has openly stated that they intend to proceed with the MDR and work is on going on the legal aspects to ensure that this happens.

Eckhard Jokisch
@Ewan Savage: This simply not correct. Both MDR and IVDR are in force and in operation since 25th May 2017! So the UK will have the MDR/IVDR as well.
The industry is in the transition phase but that’s a different story. And I admit that still a lot of manufacturers believe that nothing is going to change before 26th May 2020.
Currently a few NBs have applied to receive there re-designation.
Again: MDR and IVDR are in operation and this is not reversible.

Robert van Boxtel
In addition to #eckhard, assessing the active role of the MHRA in the MDR sofar, it is questionable that current MDD requirements will be deemed sufficient.

Richard Young
This is a contrast between regulation and practice, product manufactured for the UK under mdd won’t be CE marked after transition. The reality is that few companies will supply exclusively to the UK market…default MDR. Also, while this is certainly the insane legal position. I am unaware of any notified body planning to provide A British CE Mark BCE, under the conformity assessment system of the mdd. I think the reality is MDR certified products with the UK having a choice to accept this or do without.

Michael Maier
Your conclusion reflects wishful thinking in my opinion. Best M

Robert Wentworth, CBET
What an interesting article.

Zeljka Zagrovic
That will cause a confusion on the MD market and standards. I don’t agree with this..

Mark A. Chipperfield
The position proposed here depends on whether mutual recognition discussions get concluded in the timeline, alongside various other aspects. There is lots of (premature) speculation on this in the press and business media – but please thoroughly read the latest documents released by EC, MHRA, and UK House of Commons, before drawing conclusions that may affect your business (or client) strategy.

Mark A. Chipperfield
There is lots of (premature) speculation on this in the press and business media – but please thoroughly read the latest documents released by EC, MHRA, and UK House of Commons, before drawing conclusions that may affect your business (or client) strategy.

Shannon Rene’ Prezioso
Innovation, possible cures and possibilities for patients to live productive healthier lives free of pain and restricting barriers. Carry on!

Lars-Peter Åhs
Needs to be considered.