{"id":20527,"date":"2022-03-29T10:17:49","date_gmt":"2022-03-29T08:17:49","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20527"},"modified":"2022-03-28T11:06:56","modified_gmt":"2022-03-28T09:06:56","slug":"mdcg-last-guidelines-class-d-ivds-legacy-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/03\/29\/mdcg-last-guidelines-class-d-ivds-legacy-devices\/","title":{"rendered":"MDCG: last guidelines on class D IVDs and legacy devices"},"content":{"rendered":"\n

Last month, the Medical\nDevice Coordination Group (MDCG) <\/strong>published two\nimportant guidelines.<\/p>\n\n\n\n

MDCG 2022-3<\/strong> \u201cVerification of manufactured class D IVDs by notified bodies\u201d is\nthe first one and provides information on conformity assessment procedures<\/strong>\nfor class D in Vitro Diagnostic – Medical Devices<\/strong> (those at the highest\nrisk<\/strong>).<\/p>\n\n\n\n

MDCG 2022-4<\/strong> \u201cGuidance on appropriate surveillance regarding the transitional\nprovisions under Article 120 of the MDR\u201d is the second one and focuses the\nattention on the surveillance process regarding legacy devices, namely those\ndevices that are allowed to remain in the EU market until May 2024 because they\nare covered by valid certificates issued under the Active Implantable Medical\nDevices Directive (AIMDD) or the Medical Devices Directive (MDD).<\/p>\n\n\n\n

Below there is a\nbrief summary of the main topics addressed in each of the two guidelines.<\/p>\n\n\n\n

\"MDCG
Last guidelines on class D IVDs and legacy devices<\/figcaption><\/figure>\n\n\n\n

A conformity assessment guideline on high-risk IVD devices<\/strong><\/h2>\n\n\n\n

According to\nIVDR (EU) 2017\/746 Regulation, class D in Vitro Diagnostic – Medical Devices\nat high risk <\/strong>must undergo a particularly sophisticated conformity\nassessment procedures which requires the involvement of Notified Bodies<\/strong>\nand EU Reference Laboratories (EURL)<\/strong> subjected to rigorous testing.<\/p>\n\n\n\n

Class D devices\nparticular conformity assessment procedures are aimed at minimising possible\nhealth risks to patients.<\/p>\n\n\n\n

Firstly, class D\nIVD devices Manufacturers<\/strong> must submit reports of the tests carried\nout on each batch of devices<\/strong> and deliver samples<\/strong> of these products\nto the appointed Notified Body (NB).<\/strong><\/p>\n\n\n\n

Afterwards, the\nNotified Body should request one of the EURL laboratory<\/strong> to carry out\nbatch testing on those devices. The findings should be sent back to the Notified\nBody<\/strong> that, as the ultimate responsible for the verification process, must\nexamine the final results. Class D IVD devices<\/strong> can be placed on the\nEU market<\/strong> only if they successfully fulfil this test.<\/p>\n\n\n\n

MDCG 2022-3\nguideline is very useful for Manufactures because it clarifies the procedures\nfor authorising the placing on the market of such high-risk class D devices.<\/p>\n\n\n\n

MDCG 2022-4 on legacy devices surveillance<\/strong><\/h2>\n\n\n\n

Article 120 of\nMDR (EU) 2017\/745 Regulation on Medical Devices establishes that legacy\ndevices<\/strong> in accordance with the previous directives AIMDD or MDD are allowed\nto remain in the EU market until May<\/strong> 2024<\/strong>, as long as the Notified\nBody<\/strong> that issued the certificate keep carrying out appropriate post-market\nsurveillance,<\/strong> in compliance with supervisory requirements<\/strong>.<\/p>\n\n\n\n

MDCG 2022-4\nguideline outlines the activities that need to be carried out by the Notified\nBody (NB) in order to manage the surveillance of quality management systems\nfor legacy devices.<\/strong><\/p>\n\n\n\n

Furthermore, Manufacturer\u2019s\nduties<\/strong> are made clear, including providing the NB with safety and\npost-market surveillance reports<\/strong>, in order to allow it to carry out the necessary\nchecks on the quality management system.<\/p>\n\n\n\n

The Analysis of\nthis guideline is a must if you have legacy devices under MDD or AIMDD.<\/p>\n\n\n\n

Find out more about how we can support you in complying with MDR (UE) 2017\/745 and IVDR (UE) 2017\/746 Regulations<\/strong><\/h2>\n\n\n\n

Thema\u2019s experts\ncan help you in the process of achieving compliance with the requirements of MDR\nand IVDR Regulations.<\/p>\n\n\n\n

But that’s not the end of the story!<\/strong><\/h2>\n\n\n\n

Among Thema\u2019s\nservices we have come up with two quick solutions so that you can act\nautonomously using a few strategic templates:<\/p>\n\n\n\n