Commission Publishes Updated List of Notified Bodies’ Standard Fees
The European Commission has published an updated list of notified bodies’ standard fees.
The list is published in fulfilment of the obligation imposed on Notified Bodies by Article 50 of the MDR and Article 46 IVDR to establish and publish lists of their standard fees. The information provided in the list is not binding on either the Notified Bodies or their clients. It is rather a reference document to help manufacturers determine potential costs related to interactions with Notified Bodies.
The list of standard fees will potentially become increasingly useful
Commission publishes Monitoring of Notified Bodies: new MDR and IVDR reports
The European Commission has just published the most recent Monitoring of Notified Bodies: new MDR and IVDR reports. These are reports, required by Article 44.12 of the MDR and Article 40.12 of the IVDR, that present the results of monitoring and on-site assessment activities by EU Member States regarding notified bodies. The reports are submitted
Team-NB Position Paper on MDR/IVDR revisions
Team-NB, the European Association of Medical devices Notified Bodies, has published its Position Paper on the European Commission’s proposed revisions to the MDR and the IVDR. While the Association acknowledges that the proposed revisions provide opportunities to improve predictability, transparency and efficiency in conformity assessment, it has expressed concern regarding some aspects of the proposed revisions. These include what Team-NB perceives as reductions in
Team-NB has published a letter on cybersecurity in medical devices
Team-NB, the European Association of Medica devices Notified Bodies, has published a letter concerning cybersecurity in medical devices. The Association welcomed revisions included in the recent proposed revisions to the MDR and IVDR intended to strengthen cybersecurity in this context.
However, it considered that decisions concerning availability of medical devices and safety of patients remain with the “governance bodies” established
Q&A requirements related to notified bodies
The Medical Device Coordination Group (MDCG) has published an update to its Q&A related to notified bodies’ requirements under MDR and IVDR, MDCG 2019-6 Rev5. (https://health.ec.europa.eu/document/download/9c9c532f-013a-477c-9378-0a9e714e5549_en?filename=md_mdcg_qa_requirements_notified_bodies_en.pdf).