Selling CE marked self-test in Malta - any additional requirements?

anoia

Registered
#1
Hi all

We are a UK based manufacturer of a CE-marked self test with English labelling. We know we can sell in UK and Republic of Ireland without any extra work (translations / additional database registrations / approval of advertising materials etc), however I was wondering if we could also add Malta to that list without any extra work?

I know Malta accept English for labelling, but I was wondering if anyone knew of any other 'extra' requirements Malta may have?

The Maltese IVD Regulation (S.L.427.16 section 9.3) appears to suggest that any manufacturer without a registered place of business within Malta, needs an authorised representative.

Does anyone know if this is actually the case as it seems a little excessive if you are already an EU based manufacturer?

Thanks!
 
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