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+44 (0) 1926 800 153 info@advenamedical.com

Important information- European Services conducted by Advena Ltd

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.:  info@advenamedical.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.

 

 

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.

EN ISO 62304: 2006 Medical Device Software Validation

The topic of software validation is one that continues to cause confusion, so we have developed a series of flowcharts to help clarify the requirements. These cover:

* EN ISO 62304; 2006 medical device software – software life cycle processes
* FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Please contact Farhaan Shaikh on +44 (0)1926 800153 or via email to farhaan.shaikh@advenamedical.com for further information.

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