It would have been difficult to miss the recent news (certainly if you’re based in Europe) regarding the UK Government’s delivery of the letter to the EU Commission, invoking Article 50 of the Lisbon Treaty, where a member state officially notifies of its intention to leave the EU, and so the negotiation process begins.
So what does this mean for non-European manufacturer’s looking for an EU Authorised Representative (EC REP)?
In reality nothing has changed right now, however in the future, perhaps within 2 years it may be that UK based organisations can no-longer offer an EU Authorised Representative service. Potentially causing a certain amount of regulatory chaos, and clearly bad news all round for the medical device industry.
How will this affect Advena and our clients?
We are in what may be described as the perfect position, where 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. Advena are in the enviable position of being able to continue as an EU Authorised Representative business with offices based in the UK and in Malta and therefore, whatever the outcome of the UK’s negotiations with the EU, Advena will be here to assist and advise its clients (new and existing) regarding regulatory matters and EU medical device registrations. Another positive for our two operational locations is both acknowledge English as an official language.
Furthermore, UK medical device manufacturers may, in the future, require the services of an Authorised Representative to gain access to the EU market, while the EU and the rest of the world’s medical device manufacturers may need an Authorised Representative to gain access to the UK market, again we are in the perfect position, remember we, Advena, are based in the UK and in the EU, Malta.
There is a long and difficult path ahead for the UK and the EU, the negotiation process will not be easy or straightforward. However for medical device manufacturers who need an Authorised Representative the choice has been made a little simpler, choose Advena!
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