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UK Membership of the EU

You will have become aware that the UK has voted to leave the European Union and no doubt you are concerned about how this may affect your business.

We can assure our clients it is “business as usual” even though we are unable to ignore the possibility of an effect on medical device companies who wish to CE mark medical devices and sell throughout the EU.  The important thing to understand is that even if the exit becomes clean-cut, and that is not confirmed yet, there would be a period of at least two years, or even more, before there is any change to the regulatory status in the UK, so don’t panic!

The UK Government requires to have a negotiated solution before the UK leaves and there will be a long negotiation period before a formal withdrawal from the EU is agreed. Only the UK can implement ‘Article 50’ of the Lisbon Treaty, where a member state officially notifies of its intension to leave the EU, and there is no timing on this yet.

However, as a forward thinking organisation we have been planning for the possibility of adverse results from this vote for some months and are able to assure everyone that we will continue to serve our clients with exemplary regulatory assistance despite these challenges. 

For our authorised representative and cosmetic responsible person service we have already arranged a second legally registered business address in an alternative English speaking EU country so, and if necessary, we will always be able to maintain our legal status for representing clients within the European Community.  This will also mean we would be able to offer a local EU authorised representative / responsible person service to UK based manufacturers as this would be necessary in the event of a complete exit.  We also see having a second European office as an important and forward thinking expansion of our service base, particularly as our company grows.

Notified bodies are not immune to changes following this referendum, despite BSI announcing that they see nothing altering. It is possible that all UK based Notified Bodies may have to move their operational addresses (for CE certification) out of the UK into the EU within 2 – 3 years so expect notifications to be sent out from them.

We fully appreciate that this event could leave a feeling of uncertainty about dealings in the EU and specifically how we represent our clients. Whatever happens, and it may never happen, we will continue to serve and offer the very best advice within the ever-changing world of regulation.

As we mentioned earlier, there is no need to change anything immediately but do not hesitate contact a member of our team if you have any specific concerns or questions.

 

 

EU MEDICAL DEVICE REGULATIONS – PRODUCT LIABILITY

We are still awaiting the final legal opinions for the proposed changes to European law.

This will be essential for all manufacturers/distributors/importers selling medical devices into the European Union to have cover for product liability.  The scope of such cover must include all 28 EU states.

Should Clients have problems with such cover we are already in discussion with two international product liability insurance brokers who should be able to assist.

UK/EU REFERENDUM

This is a subject that is on everybody’s lips within all Industries at the moment ………..

The UK population (and ex pats abroad) will be voting on the 23rd June as to whether the UK is to remain in the EU.

Whatever the results we assure all our clients that it will be business as usual for Advena in respect of gaining and retaining  CE mark approvals for clients.  There is no dispute that the need for CE approval will always be a key medical device regulatory requirement for both European and global trade.

Meet Advena at MEDICA 2015

Two members of our team will be attending MEDICA 2015 in Düsseldorf on Monday 16th and Tuesday 17th November.

If you would like a meeting please email in advance to arrange a convenient time:

Anthony Jacqueline
Anthony Kirby
Business Manager
anthony.kirby@advenamedical.com
Jacqueline Spittle
Quality Manager
jacqueline.spittle@advenamedical.com
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