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…
Several recent additions have been added to the NANDO databases for Notified Bodies (NBs) designated under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746). The latest assessment bodies to be designated are Bureau Veritas Italia and the Certification Division of the Spanish Agency for Medicines and Healthcare Products (AEMPS). 32…
The EC Medical Device Coordination Group (MDCG) has published a new guidance clarifying the requirements of Article 16 of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) relating to the circumstances under which EU importers and distributors of medical devices may be regulated as manufacturers. The guidance, MDCG 2021-26, ‘Questions…
An ad hoc task force of the EC Medical Device Coordination Group (MDCG) recently issued a report to the group clarifying many aspects of which transitional provisions in Article 120 of the Medical Device Regulation (MDR, 2017/745) would apply to so-called ‘legacy devices’. The report recommended that the MDCG accept the report as written and…
