Was interested in whether Brexit would create a headache for Oncosil as they are using the British Standards Institute (BSI) as the pathway to the CE Certificate. In short; there is lots of risk around this.
On 29 January 2019 the BSI provided this update to the market relating to the implications of Brexit on medical device access to the EU for products certifified by a UK notified body:
We specifically asked the Competent Authorities for the EC policy on migration and validity of CE certificates from a UK notified body post 29 March 2019, if Article 50 is enacted and applied on this date without an agreed transition deal.
The Competent Authorities advise:
a) As of 30 March 2019, the UK will become a third country and the CE certificates will lose their validity.
Interesting stuff right!! Importantly for OSL BSI noted the following in regards to products that are in "work in progress" stage:
For projects in pre-certification recommendation or pre-certification decision making stage (Panel) we will migrate the existing certificate to the Netherlands NB before the end of March. We will move work in progress (WIP) to the NL NB to finish and issue an amended certificate from NB 2797. This action will alleviate the need to complete this work in BSI UK NB and subsequently complete the migration by 29 March.
So it appears that the immediate risk to Oncosil is avoided, but wow, something like this has the potential to break a company at this stage of their life cycle. I am surprised that Oncosil didn't release any information to the market around this. Maybe they didn't want to spook anyone unnecessarily...I wonder whether this is the reason for the pull back in share price and whether this represents an opportunity to buy??
Further information on this for anyone who wants to do a little more homework can be found here: https://www.bsigroup.com/en-GB/medical-devices/news-centre/enews/2019-news/urgent-brexit-implications-for-market-access---60-days-out-from-29-march-2019/