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MedTech Europe publishes ‘Urgent call for action’ infographic over MDR/IVDR shortcomings

The pan-European industry association for medical technology manufacturers, MedTech Europe, has developed and published an infographic to bring attention to its ‘Urgent call for action’ to European legislators to support high-level solutions to the delays, bottlenecks and other problems that have beset the introduction of the new Medical Device Regulations (MDR, 2017/745 and IVDR, 2017/746)….

November 12, 2022
EU publishes guidance on Authorised Representatives

The European Commission’s Medical Device Coordination Group (MDCG) has published a new guidance on Authorised Representatives under the Medical Device Regulations (MDR, 2017/745 and IVDR, 2017/746), replacing the January 2012 MEDDEV 2.5/10 ‘Guideline for Authorised Representatives’ which applied to authorised representation under the Medical Device Directives (MDD and IVDD). The new guidance is MDCG 2022-16…

November 4, 2022
Commission’s own report points to MDR/IVDR crisis ahead

At the 24 October meeting of the MDCG, some alarming, but not unexpected, details relating to notified body capacity in the run-up to the final days of implementation of the Medical Device Regulation (MDR, 2017/745) and the In Vitro Diagnostic Regulation (IVDR, 2017/746) were presented by the European Commission following a survey of notified bodies….

October 29, 2022
Commission plays catch-up with 19-point action plan

Is the European Commission at last listening to the MedTech industry as further delays and the lack of notified bodies threaten the final implementation stages of the new device regulations? In this context, the Medical Device Coordination Group (MDCG) published guidance document MDCG 2022-14, titled ‘Transition to the MDR and IVDR – Notified body capacity…

October 26, 2022
MHRA advises industry of UKCA application delay

In a ‘letter to industry‘ dated 22 October 2022, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), advised that it was implementing a 12-month extension to the current ‘standstill period’, mainly because additional time is needed to introduce the new medical device regulation that was initially planned to take effect from 1…

October 25, 2022
FDA proposes to update Breakthrough Device guidance

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated ‘breakthrough products’. The agency is also considering expanding its criteria for breakthrough devices to include products that treat rare diseases, as well as non-addictive products to treat…

October 25, 2022