The EU Commission has welcomed the adoption by the EU Parliament for the proposal that has been put forward regarding the extension in the transition periods for certain IVDR’s. The new rules will give more time for manufacturers to transition to the new requirements of the IVDR and aims to mitigate the risk of device … Read more
On December 5th, 2023, the EU Commission adopted implementing regulation (EU) 2023/2713 designating 5 European Union reference laboratories in the field of in vitro diagnostic medical devices. These 5 European Union reference laboratories will be involved in the conformity assessment of Class D in vitro diagnostic devices and other advisory tasks. The important tasks these … Read more
In order to address the slow transition and prevent shortages of IVDs on the market, the amending regulation (EU) 2022/112 of 25 January 2022 introduced a stepped extension of transition periods based on the classification of the IVD. While the amending regulation has provided additional transitional time, the first deadline of 26 May 2025 for … Read more
The 12th Notified Body for Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices has been included in the list of designated Notified bodies available in the European Commission’s NANDO information system. The new notified body is Sertio Oy and based in Finland. … Read more
The 11th Notified Body for Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices has been included in the list of designated Notfied bodies available in the European Commission’s NANDO information system. For the NANDO information system, please click here. For more information … Read more
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 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
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
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