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…
Now available from the Commission website are the following new guidance and informational documents: MDCG 2021-22 rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies MDCG 2022-13 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies MDCG 2022-14 – Transition to…
The US Food and Drug Administration has now published its revised user fees for its fiscal year (FY) 2023, which starts on 1 October 2022. Any submissions or applications arriving at the Agency on or after 1 October 2022 will need to have paid the new fees, which are: As can be seen from the…
The US Food and Drug Administration has published the final version of its guidance document ‘Clinical Decision Support Software – Guidance for Industry and Food and Drug Administration Staff’, available from here. Three years have passed since the Agency issued a draft of the document, to which many comments were received as a result of…
The European Commission has published the latest version of its Medical Device News Newsletter, available from here. Topics covered include: MDCG publishes a list of actions on notified body capacity and availability of medical devices and IVDs Common specifications for several types of high-risk diagnostics Guidance on harmonised administrative practices & alternative technical solutions EC…
