EU Reference Laboratories The European Commission has adopted two implementing acts in order to lay the groundwork in setting up EU Reference Laboratories for high-risk IVDs. These acts seem to be rather robust and very specific, meaning that laboratories wishing to apply as a Reference Laboratory for the testing of such devices should be able … Read more
MDCG 2022-11 The EU MDCG have published a Position Paper titled “Notice to manufacturer to ensure timely compliance with MDR requirements”. In summary, the document is really a stern warning to manufacturers who have not yet transitioned to the EU MDR, making it clear that those products which do not comply with the regulation requirements … Read more
The updated Blue Guide was published in the Official Journal of the European Union towards the end of June. It includes updates concerning the implications of Brexit, Regulation (EU) 2017/745 & (EU) 2017/746 and more. We have only begun to pick through this new updated text and may have updates on our website in the … Read more
The MDCG have published a template for the Summary of Safety and Performance (SSP) as required by the EU IVD Regulation 2017/746 (IVDR) for Class C and Class D devices. The format of the SSP will depend on whether the device used is intended for self-testing. If it is not, then there shall be another … Read more
As most IVD manufacturers will know, a derogation to the IVDR was passed earlier this year which allows for a stepped transition in accordance with Article 110(3) of the IVDR. This allows for General IVDs registered under the IVD Directive which will require Notified Body intervention under the Regulation an extended transition period. However, there … Read more
A Q&A document on the EU Regulation’s Unique Device Identification (UDI) system has been published to answer some of the most burning questions when it comes to the application of UDI to medical devices and IVDs. The document covers the following themes: UDI-DI. Basic UDI-DI (BUDI). UDI Labelling. UDI Rules for System and Procedure Packs … Read more
The EU MDCG have published guidance document MDCG 2022-6 to provide clarifications on significant changes as mentioned in Article 110 of the EU IVDR. Manufacturers using this Article in order to continue placing their legacy products on the EU market will know that understanding the meaning of a significant change will be key in continually … Read more
26 May 2022 has now come and gone, bringing with it a new era of IVD Regulation in the EU. Unfortunately, the outgoing Directive was unable to keep up with the advances within the IVD sector, with many relatively high-risk products falling under the General IVD category, such as those detecting cancer within a sample. … Read more
We are extremely pleased to announce that Advena Ltd. in Malta has successfully obtained their ISO 13485 certificate from EU Notified Body IMQ [0051] following a 2-stage certification audit. We are especially pleased to have achieved certification with no noted nonconformities. For a copy of our ISO 13485:2016 Certificate for your records, please [click here]. … Read more
The European Commission published a formal proposed amendment [COM(2021)627] to the In Vitro Diagnostic medical devices Regulation (EU) 2017/746 (IVDR) on 14 October 2021 which specifically updates the transitional provisions in Article 110. This is good news for IVD manufacturers, who have long been hoping for additional time in order to meet the new requirements … Read more
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