{"id":13990,"date":"2020-03-27T12:56:03","date_gmt":"2020-03-27T11:56:03","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=13990"},"modified":"2023-01-24T14:59:11","modified_gmt":"2023-01-24T13:59:11","slug":"europe-mdcg-guideline-on-significant-changes-period-of-grace","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/03\/27\/europe-mdcg-guideline-on-significant-changes-period-of-grace\/","title":{"rendered":"EUROPE: MDCG guideline on significant changes during Period of Grace"},"content":{"rendered":"\n

The Medical Device Coordination Group (MDCG<\/strong>) approved the guideline on significant changes<\/strong> required by article 120 of the MDR concerning the Period of Grace MDD or AIMDD certificates. <\/p>\n\n\n\n

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MDCG guideline on significant changes during Period of Grace <\/figcaption><\/figure>\n\n\n\n

The article 120, paragraphs 2 and 3, of the MDR (EU) 2017\/745 states\nthat the devices with a valid certificate, released by a Notified Body\naccording to MDD or AIMDD, can be placed into the market or put into service\nafter the MDR application date under certain conditions and not later than May 26, 2024.<\/strong><\/p>\n\n\n\n

One of these conditions is that no significant change in the product occur\nand it is therefore fundamental for the Manufacturers and Notified\nBodies to understand what \u201csignificant change\u201d<\/strong> means. <\/p>\n\n\n\n

In fact, no emission of new MDD\/AIMDD certificates, including those\nmodified or integrated, are allowed pursuant to article 120, paragraph 3. In particular,\nif the Manufacturer wishes to apply a \u201csignificant\nchange in the design and intended purpose<\/em>\u201d, the implementation of such change\nis verified by the Notified Body and the evaluation determines if a\ncertificate, in compliance with the MDD\/AIMDD, keeps its validity pursuant to article\n120 of the MDR. <\/p>\n\n\n\n

The guideline includes flow charts, a main chart and five sub-charts, to\nsupport Manufacturer and Notified Bodies to assess if a change must be\nconsidered significant or not according to article 120, paragraph 3, of the\nMDR. <\/p>\n\n\n\n

MDCG recently published other guidelines:<\/p>\n\n\n\n