IVD registration in EU - Northern Ireland based company

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Fpatterson

Registered
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My client is a Northern Irish based IVD manufacturer which means they do not require an EC authorised rep to continue to market their tests in Europe. Pre-brexit, they registered their test portfolio with the MHRA, as general IVDs - self certification under the IVDD? Post-brexit how do they register their products for continued use in Europe? everything i can find online discusses the need to register the IVD product(s) with the European CA where your selected Authorised Representative is based. However as they do not need an Authorised Rep, this does not apply.
Note - i'm seeking advise on the current directive (IVDD) procedures specifically.
 
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