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mahamad shafi S S
RA
December 2018
BREXIT impact on representation
< 1 min reading time

Hi all. If my EC representative is presently based in the UK, do I have to change him? If so, by what date?

What is the BREXIT on non-EU manufacturers with UK-based representation?

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Asked on December 18, 2018 4:54 am
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Robert Packard

A European Authorized Representative is required for any company that is CE Marked and does not have a physical presence in the EU. The UK is currently in the EU, but as of March 29th 2019 the UK will be exiting the EU (i.e., Brexit). The expectation was that there would be transition agreements and mutual recognition agreements signed. However, that has not gone smoothly. British NBs have been forced to relocate their offices to Ireland, Netherlands and other EU member states in anticipation of the Brexit. The same is likely to happen for UK Authorized Representatives. They will no longer be within the EU, and companies will need to sign new contracts with an AR in an EU member state on or before March 29, 2019.

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mahamad shafi S S

I saw some news on wellkang website, that , wellkang can continue as a authorized representative till 2020 December for Non EU Manufacturers. ( India) is it true ?

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Robert Packard

I'm not sure that their information is accurate, and it would be biased. However, if you have device that is regulated by a NB then you can ask the NB. If you have a Class I device you could ask one of the Competent Authorities for a country you are registered in.

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mahamad shafi S S

Thanks sir, in case of class 3 device , could you suggest more.

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Robert Packard

In the case of a Class 3 device, every change requires approval by the NB. A change in your Authorized Representative (AR) requires updating the label and Instructions for Use, your contract with the AR and your Declaration of Conformity. Of course the Technical File should be updated with these changes as well. Therefore, you will want to get feedback from your NB in writing as to whether you are required to update the AR by March 29, 2019 or not. If they say you need to update the AR, then you need to agree on a date they will review and approve the changes.

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Gottfried Griesmayr

There is no difference for risk classes regarding the need of an authorised representative in one of the EU member states! Any manufacturer who has no registered place of business in the EU needs an AR, who is the contact for a competent authority in one member state. This applies also for class I devices and the NB involved for higher classes is not relevant for this requirement (MD vigilance is the business of competent authorities for all classes).
It is still not clear what you will need in the future. You may need an AR in EU and UK and Wellkang is apparently offering both, means they will have registered places of business in both areas. The same solution is chosen by large NB's. BSI has already achieved accredidation for a subsidiary in The Netherlands and is in a save position regarding BREXIT.

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mahamad shafi S S

Thanks Gottfried

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At this time to my knowledge, BSI is the only UK NB to have succeeded in accreditation in the EU in case of a hard Brexit - others have applied, but cannot promise to beat the deadline of 29 March...

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