{"id":20946,"date":"2022-05-30T14:11:02","date_gmt":"2022-05-30T12:11:02","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20946"},"modified":"2022-05-30T14:12:59","modified_gmt":"2022-05-30T12:12:59","slug":"europe-mdcg-2022-6-and-significant-changes-in-period-of-grace","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/05\/30\/europe-mdcg-2022-6-and-significant-changes-in-period-of-grace\/","title":{"rendered":"EUROPE: guidance MDCG 2022-6 and Significant Changes in Period Of Grace"},"content":{"rendered":"\n

MDCG 2022-6 guidance\non Significant Changes<\/strong> to Legacy IVD Devices pursuant to Article 110(3) IVDR was published a\nfew weeks ago.<\/p>\n\n\n\n

\"EUROPE:
EUROPE: guidance MDCG 2022-6 and Significant Changes in Period Of Grace<\/figcaption><\/figure>\n\n\n\n

IVD legacy: what\nare the “significant changes”?<\/strong><\/h2>\n\n\n\n

First, it is\nimportant to clarify that legacy IVDs<\/strong> are all those devices covered by a\nvalid certificate in accordance with Directive 98\/79\/EC (IVDD) and which,\naccording to Article 110 (3) may continue to be legally placed on the market after\n26 May 2022<\/strong> provided that no significant changes<\/strong> are made in the\ndesign and intended use of the devices.<\/p>\n\n\n\n

This \u201cPeriod of\nGrace\u201d does not<\/strong> apply to those CE marked IVD devices<\/strong> which do\nnot require the intervention of a Certified Body<\/strong> (non-sterile IVD class A)\nand which therefore must demonstrate their fully compliance with the IVDR starting\nfrom 26 May 2022.<\/p>\n\n\n\n

In its essence,\nMDCG Guideline 2022-6 provides valuable help in the interpretation and\nverification of the “significant changes”<\/strong> pursuant to Article\n110.3 of IVDR (EU) 2017\/746.<\/p>\n\n\n\n

“Significant\nchanges” refer to product or process changes that impact the design and\nintended use of the device. The significant changes, pursuant to art.110 must\nbe communicated to the Notified Body and entail the forfeiture of the IVDD\nPeriod of Grace certificate with the consequent need to issue an IVDR\ncertificate.<\/p>\n\n\n\n

To help\nmanufacturers understand if a change can be considered as significant, the MDCG\n2022-6 provides several flow charts<\/strong> that take into account changes to\nthe device in many applications (intended use, design, software, formulation\nand sterilisation).<\/p>\n\n\n\n

Other harmonised\nIVDR standards published<\/strong><\/h2>\n\n\n\n

The European Commission, with the Commission Implementing Decision\n(EU) 2022\/729 <\/strong>of last 11 May 2022, has formalized other harmonised\nstandards IVDR (EU) 2017\/746 for In Vitro Diagnostic Medical Devices.<\/strong> <\/p>\n\n\n\n

Standards for quality management and risk management have now been added\nto the harmonised IVDR standards<\/strong> already published in July 2021 and\nJanuary 2022:<\/p>\n\n\n\n