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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? Marked as spam
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Private answer
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. Marked as spam
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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 ? Marked as spam
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Private answer
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. Marked as spam
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mahamad shafi S S
Thanks sir, in case of class 3 device , could you suggest more. Marked as spam
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Private answer
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. Marked as spam
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Private answer
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). Marked as spam
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