The US Food and Drug Administration (FDA) has issued a draft guidance document titled ‘Content of Human Factors Information in Medical Device Marketing Submissions: Draft Guidance for Industry and Food and Drug Administration Staff“ The draft is intended to be, when finalised, a companion guidance to document ‘Applying Human Factors and Usability Engineering to Medical…
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)….
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…
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….
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…
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…
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…
On 13 October, the European Commission’s Committee on Medical Devices voted on the draft Commission Implementing Regulation on the common specifications (CS) for groups of products without an intended medical purpose, as listed in Annex XVI of the Medical Device Regulation (MDR, 2017/745), copy available from here. The industry group representing manufacturers of these product…
TEAM-NB, the industry association for European notified bodies designated under MedTech regulations, has published a position paper titled ‘Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 – Information to be supplied by the manufacturer – a collaborative notified body approach’. The 44-page document…
TEAM-NB, the industry association for medical device notified bodies, has published a number of new position papers in recent weeks, including: Transfer agreement template: specifying the terms of voluntary change of notified body under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 Data generated from ‘off-label’ use of a device under the EU Medical Device Regulation…
