{"id":19655,"date":"2021-11-25T12:08:07","date_gmt":"2021-11-25T11:08:07","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=19655"},"modified":"2021-11-29T11:57:51","modified_gmt":"2021-11-29T10:57:51","slug":"proposal-extend-ivdr-eu-2017-746-regulation-in-vitro-diagnostic-medical-devices","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/11\/25\/proposal-extend-ivdr-eu-2017-746-regulation-in-vitro-diagnostic-medical-devices\/","title":{"rendered":"EUROPE: a proposal to extend the IVDR (EU) 2017\/746 Regulation"},"content":{"rendered":"\n

UPDATE OF 25 JANUARY 2022<\/strong><\/p>\n\n\n\n

OFFICIAL PROGRESSIVE ROLL-OUT OF REGULATION <\/strong>
IVDR<\/strong> (EU) 2017\/746 FOR CERTAIN IVD DEVICES.<\/strong>
REGULATION (EU) 2022\/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017\/746 as regards transitional provisions for certain In Vitro Diagnostic Medical-Devices and the deferred application of conditions for in-house devices. <\/p>\n\n\n\n

Source:<\/em><\/p>\n\n\n\n

REGULATION (EU) 2022\/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017\/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices, Official Journal of the European Union, 28 January 2022<\/a><\/p>\n\n\n\n

UPDATE OF 20 DECEMBER 2021 <\/strong><\/p>\n\n\n\n

UPDATE IVDR (EU) 2017\/746. <\/strong>
Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation!<\/p>\n\n\n\n

The European Council have join the Parliament in adopting the proposal for IVDR transition!
The In Vitro Diagnostic Medical Devices Regulation that will apply as from 26 May 2022, can now be progressively rolled out, thanks to its adoption by the European Parliament and the Council. <\/p>\n\n\n\n

Sources:<\/em><\/p>\n\n\n\n

European Parliament legislative resolution of 15 December 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017\/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices <\/a><\/p>\n\n\n\n

Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation, Press corner European Commission, 20 December 2021<\/a><\/p>\n\n\n\n

\"in<\/figure>\n\n\n\n

On October 14, 2021 the European Commission<\/strong> published a proposal to postpone the IVDR (EU) 2017\/746 Regulation full application deadline<\/strong> (May 26, 2022) regarding In Vitro Diagnostic Medical Devices.<\/p>\n\n\n\n

Following significant\ndelays in IVD sector<\/strong> in adjusting to the Regulation which replaces IVDD\nDirective 98\/79\/CE, and the requests from the EU member States, the European\nCommission took action to avoid possible disruptions of crucial public health\ndevices supply.<\/strong><\/p>\n\n\n\n

According to\nArticle 110 of the (EU) 2017\/747 Regulation, only devices with a certificate\nissued by a Notified Body already in accordance with Directive 98\/79\/CE (around\n8%) will benefit from transitional provisions, which the European Commission\nsuggests enlarging to all IVDs, extending the transitional period deadline<\/strong>.<\/p>\n\n\n\n

Why such a proposal?<\/strong><\/h2>\n\n\n\n

In favour of the necessity of a postponement, the Commission highlighted that about 70% of clinical decisions<\/strong> are taken using of In Vitro Diagnostic Medical Devices such as HIV tests, pregnancy tests, or SARS-CoV-2 tests, and it has underlined the high number of small and medium enterprises (SMEs) active in the field.<\/p>\n\n\n\n

While with IVDD Directive just about 8% of all In Vitro Diagnostic Medical Devices on the market required the participation of Notified Bodies and their conformity assessment, with the IVDR (EU) 2017\/746 Regulation, around 80% of In Vitro Diagnostic Medical Devices will undergo assessments by Notified Bodies. <\/strong>This means that, before placing their products on the market, Manufacturers will have to appoint a Notified Body to obtain one or more certificates after having completed a proper conformity assessment procedure, which will take at least one year on average.<\/p>\n\n\n\n

Two main\nfactors<\/strong> have emerged from these important and\ndemanding features, which according to the Commission, justify the need of postponing\nthe transitional period deadline <\/strong><\/p>\n\n\n\n