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MDR / IVDR Article 13 Regulatory Importer Service

Advena Services Limited (ASL) is pleased to announce the launch of a much-needed service. Many clients who use Advena Limited as their EU Authorised Representative have asked on a number of occasions if we can also take on the regulatory responsibilities of Article 13. These previous requests have in the past been unfortunately declined due to what had been seen as a conflict of interest.

But now we have good news!

importer

Introducing Advena Services Limited (ASL) the newest member of the Advena group of companies, set up specifically to answer the needs of medical device manufacturers who are struggling to find a suitable partner without disrupting their well-established supply-chain and logistical routes to shipping to the EU.

Advena Services Limited is registered in EUDAMED and has acquired its single registration number (SRN) MT-IM-000029828.

For more information regarding this exciting new service, please email ASL at importer@advena.mt

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