There has been a new notified body that have been designated under the IVDR. The new notified body: SGS FIMKO OY is from Finland. This new addition brings the total number of notified bodies under the IVDR to 19. More information about this notified body can be found using the following link
TEAM NB has recently updated their Position Paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746”. To offer some background to this document, TEAM NB has developed unified best practice guidance to clarify expectations for technical documentation submissions under the … Read more
Since the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into effect, the administrative workload for IVD manufacturers has increased significantly. Under the IVDR, Notified Bodies are required to review the technical documentation for Class B and Class C IVDs (used by laboratory professionals) through sampling during the validity of their certificates. Currently, … Read more
The Maltese Medicines Authority (MMA), in collaboration with other EU competent authorities, has introduced additional mandatory national measures to increase transparency of medical device and in vitro medical device registrations. New Mandatory Requirements: All medical devices including in vitro medical devices, regardless of classification must be registered with the competent authority by the authorised representative … Read more
There has been a new notified body that have been designated under the IVDR. The new notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. is from Poland. This new addition brings the total number of notified bodies to 18. More information about this notified body can be found using the following link
The MDCG has released a guidance pertaining to Q&A on performance studies relating to IVDR. To offer some background to this document, this document is intended for sponsors of performance studies involving in vitro diagnostic medical devices (IVDs) conducted under Regulation (EU) 2017/746 (IVDR). It also provides relevant information for manufacturers supplying IVDs for use … Read more
There has been a new notified body that has been designated under the IVDR. The notified body is from Norway. The details of this notified bodies can be seen below: More information about this notified body can be found using the following link
Two new standards have been harmonised with the IVDR. Both standards are related to sterilization. The Implementing Decision can be accessed using the following link
There has been a total of 3 new notified bodies that have been designated under the IVDR. The notified bodies are from Belgium, Spain and Italy respectively. The details of these notified bodies can be seen below: These new additions bring the total number of notified bodies to 16. More information about these notified bodies … Read more
Manufacturers of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR) must be aware of a fast-approaching regulatory milestone. In accordance with (EU) 2024/1860, in order to benefit from the extended IVDR transition periods, manufacturers must satisfy a number of criteria, two of which will be due at the end of May. These … Read more
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