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…
Italy has added another notified body (NB) to those now designated to operate under the EU Medical Devices Regulation (MDR, 2017/745), making a total of 24 available for use by device manufacturers, according to the NANDO website. Milan-based Certiquality, NB reference number 0546, is the latest to be added to the list of NBs designated…
The EU Commission has proposed an amendment to the transition of the In Vitro Diagnostic Regulation (IVDR, 2017/746) according to a press release and an accompanying Q&A webpage. In summary, the Commission has proposed that higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition…
The EC Medical Device Coordination Group (MDCG) has now published its guidance reference MDCG 2021-24, ‘Guidance on classification of medical devices’, to help manufacturers of devices regulated by the Medical Device Regulation (MDR, 2017/745) reach the correct conclusion about specific devices. The guidance follows the same format used for the preceding guidance relating to the…
The US Food and Drug Administration has now published its final rule on the de novo pathway for medical device clearance, clarifying the requirements for manufacturers whose devices may need to use the route in future. The 84-page final rule includes only minor changes from the 2018 draft rule. The pathway is used by manufacturers…
