A revised MDCG guidance document has been released, MDCG 2021-22 Rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746. According to Article 48(6) of Regulation (EU) 2017/746 … Read more
The EU Commission has in place a draft implementing regulation, reclassifying certain active products without an medical intended purpose. Certain devices that fall into the category of High intensity electromagnetic radiation emitting equipment without an intended medical purpose are due to be reclassified to ensure an appropriate conformity assessment of those active products is consistent … Read more
Advena Ltd in Malta continues to grow and is now looking to recruit an experienced Business Administrator to join their team of regulatory specialists on a full-time basis. For more information regarding this position please visit the Jobs in Malta recruitment website: [Jobs in Malta – Business Administrator]
Advena has some exciting news, we are pleased to confirm our participation in the following exhibitions: MED-TECH World in Malta, 17th and 18th November 2022. We have secured a prime location at the main entrance, Booth S1, come to Malta enjoy the winter sun and connect with healthcare technology. Arab Health in Dubai, 30th January … Read more
The European Commission has published Commission Regulation (EU) 2022/1107 which lays down Common Specifications (CS) for certain Class D In Vitro Diagnostic (IVD) medical devices in relation to the IVD Regulation 2017/746 (IVDR). Common Specifications are a set of technical and/or clinical requirements which provide a means of complying with the legal obligations for a … Read more
Common Specifications for Certain Class D IVDs Commission Implementing Regulation (EU) 2022/1107 has been published and will come into effect on 25 July 2022 to lay down the Common Specifications for the following Class D IVDs with respect to requirements regarding performance characteristics as detailed in Sections 9.1(a-b), 9.3, 9.4(a) of Annex I of the … Read more
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
Advena Ltd
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