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
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
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
It would seem like the new IVD Regulation (IVDR) has been behind the scenes, overshadowed by the Medical Device Regulation (MDR). The IVDR brings with it a totally new classification system, which resembles that of medical devices. Previously, IVDs were classified as either general, self-testing, list A or list B devices. In contrast, with this … Read more
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