{"id":6379,"date":"2023-01-16T12:37:23","date_gmt":"2023-01-16T11:37:23","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-and-ivdr-amendment-proposal-whats-new\/"},"modified":"2023-01-16T12:42:01","modified_gmt":"2023-01-16T11:42:01","slug":"mdr-and-ivdr-amendment-proposal-whats-new","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-and-ivdr-amendment-proposal-whats-new\/","title":{"rendered":"MDR and IVDR amendment proposal: what’s new"},"content":{"rendered":"\n

In the last days, the EU Commission has presented a proposal for a Regulation amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.<\/em><\/strong><\/h2>\n\n

As announced last December at EPSCO<\/a>, the European Commission has formulated a proposal that introduces a longer transition period to comply with the new requirements, in order to allow more time to certify medical devices and mitigate the risk of market shortages.<\/p>\n\n

Ente Certificazione Macchine<\/strong>, as Notified Body No. 1282 for Regulation (EU) 2017\/745, is already working to better understand and implement the Commission’s proposal. In fact, in the past few days, our staff from the Medical Devices Division<\/em> took part in an in-depth webinar and discussion<\/strong> organised by Team-NB<\/a>, which involved all European Notified Bodies. The discussion highlighted the views and concerns<\/strong> of the attendants, as well as the desire to find shared solutions and common interpretations<\/strong>, in order to make the implementation of the amendments as smooth as possible.<\/p>\n\n

<\/div>\n\n

THE PROPOSAL OF AMENDMENT<\/strong><\/h2>\n\n

Despite the progress in the implementation of Regulations (EU) 2017\/745 and (EU) 2017\/746, the transition to the new regulatory regime suffers from the limited capacity of notified bodies to certify medical devices in accordance with MDR and the complex preparedness of manufacturers for the new requirements. On 6 January, therefore, the EU Commission published a proposal to amend the MDR and IVDR<\/a>, which must now be examined and approved by the European Parliament and the Council in an accelerated co-decision procedure.<\/p>\n\n

<\/div>\n\n

KEY ELEMENTS OF THE PROPOSAL<\/strong><\/h2>\n\n

Considering that this is a conditional proposal<\/strong>, i.e. subject to special conditions to be fulfilled in order to benefit from the changes, the main amendments concern:<\/p>\n\n