This is a follow-up on the news we provided in our Newsletter last month concerning the EU regulatory changes that could occur following the decision for the UK to leave the European Union, a decision referred to as Brexit by the media. This outcome of this may be relevant as Advena Ltd are a UK registered business and the current and future regulations state that an EU Authorised Representative is to have a registered place of business within the European Union.
Essentially we wish to assure you that no changes will be required in the short term and we will be always be able to fully administer our English speaking services from our UK offices despite the legal implications of the UK decision.
The political ramifications are likely to create a long drawn out process to untangle the UK from the EU and could easily take 2 – 3 years, and there is still a possibility that the scenario could be reversed. Even after negotiations are complete the relationship between the UK and EU for Medical Device Laws may remain unchanged.
However, we at Advena Limited understand the challenges that the Brexit vote may create and have developed a strategy to protect our clients from any possible future effects and hence we have just set-up a second EU registered business address in Malta, another English speaking EU country. This means that we would be able to keep our administration office in the UK but process our EU Authorised Representative services via our newly registered EU business.
At this stage we are only contracting new clients to our new Maltese address and registering them with the Maltese Competent Authority – the Malta Competition and Consumer Affairs Authority (MCCAA). This is an alternative to registering with the UK Competent Authority (MHRA) as it is uncertain how the UK authority will need to operate in the future.
It must be stressed that all medical device registrations in Europe, regardless of which Competent Authority was involved, will be funnelled to have a Single Registration Number (SRN) under the new EU regulations.
There is no real immediacy to make any changes to your regulatory status but we would recommend that you could consider transferring your Advena Limited EU Authorised Representative service contract to our Maltese office address. We will discuss this with you when your annual renewal is signalled and if you do change then your devices would be re EU registered in Malta at no cost to yourselves.
Our new Maltese office is: Advena Limited, Tower Business Centre, 2nd Flr, Tower Street, Swatar, BKR 4013 Malta.
The Advena Ltd main administration and accounts will always remain in the UK and the telephone and email are unchanged for both registered addresses; i.e.: email@example.com Tel: +44 (0) 1926 800 153.
I hope this helps to clarify the situation and will calm any concerns you may have, however if you have any further questions please do contact us.