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Brexit and the need of an EU Authorised Representative for UK medical device businesses

26th February 2019

By Medilink member Advena Ltd

Of course all this is may be conjecture – and listening to the news may not help – but it looks like after the 29th March 2019 deadline an EU based Authorised Representatives (EC Rep) will be needed if UK device businesses export devices to markets where a CE mark is required.

However, if a deal is struck between the EU and the UK, and it is passed by UK Parliament, an implementation period should commence allowing UK manufacturers until 31st December 2020 to continue to supply CE marked devices in to the UK market as an alternative to the new proposed MHRA registration.

If they want to continue to sell into the EU, and other markets that demand the CE mark, they will need to appoint an EC Rep. This will need changes to technical information, including, but not limited to, packaging, product labels, IFU’s, brochures, CE Certificate, and Declarations of Conformity – in places where you would be expected to indicate the name and address of an EU based EC Rep.

In the event that UK Parliament votes against a deal that has been agreed between the EU and UK Government the UK could leave the EU immediately. This would mean no implementation period and the EU may not commit to a transition period. Therefore UK device manufacturers could potentially be locked out of the EU until such time that they have appointed a EU based EC Rep and updated device registrations. Therefore the 29th March 2019 could be a critical date.

UK manufacturers should be prepared to move quickly in the event of a no deal Brexit and even if a deal is struck there is no guarantee that EU Competent Authorities, or non UK customers, will accept CE marked devices after any UK only transition period.

Consultants, and particularly Advena Ltd (www.advernamedical.com) who have a second EU address, are available help to assure continuity with an EC Rep based in the EU.

Failure to appoint an EC REP in either potential outcome will effectively lock UK manufacturers out of the EU market and will invalidate existing CE marks.

Find out how you can prepare for Brexit by coming along to our event on the 12th March, in partnership with Gowling WLG, featuring special guest speaker Anthony Kirby, Director of Business Services at Advena Medical.

Anthony specialises in helping UK Medical Device Manufacturers to understand the requirements needed to appoint an EU Authorised Representative EC REP.

Find out more about the event and register your place here.

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