There is now the choice of 13 designated notified bodies for the IVD Regulation as articulated here.
Ben KempSeptember 11, 2024
Dear Members, MedTech Europe have drafted a manufacturers declaration to Regulation (EU) 2024/1860, the latest IVD regulation transitional legislation. The declaration can be used to support the continued use of IVD Directive Certificates that have expired, but where the manufacturer continues to meet the requirements of the updated legislation and Article 110 of the IVD Regulation 2017/746. To: Regulatory Affairs…
Ben KempSeptember 11, 2024
The Australian Government have updated their clinical trial forms. You can find further information here.
Ben KempSeptember 11, 2024
In preparation for incoming AI legislation, BSI has proactively developed an Algorithm Auditing and Dataset Testing service to help organizations prepare for success. An Algorithm Auditing & Dataset Testing confirmation letter from BSI demonstrates to customers, regulators, and other stakeholders that your algorithm performance claims have been verified by an impartial and independent third party. Establish trust and credibility in…
Ben KempSeptember 11, 2024
The Frequently Asked Questions (FAQs) on the Data Act will support its implementation. You can find the FAQs here.
Ben KempSeptember 11, 2024
DoP curbs unethical practices with new guidelines for medical device promotions, mandating transparency and strict adherence to regulatory approval. You can read the article here.
Ben KempSeptember 11, 2024
The below draft response from Scottish Government, maybe of interest to Scottish based members. As climate change impact increase, we will increasing need to adapt businesses to cope with the impacts. We’re already seeing climate change being a focus of business insurance, and access to finance, both in terms of business risk including supply chain risk. We’re seeing the need…
Ben KempSeptember 11, 2024
FDA is hosting a webinar on 24 October on its total product life cycle (TPLC) oversight of in vitro diagnostics (IVD). Stakeholder questions need to be submitted by email by 23 September.
Ben KempSeptember 11, 2024
Notify MHRA about a clinical investigation for a medical device Page summary: Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Updated ‘In Vitro Diagnostic Medical Devices (IVDs)’ section, Time updated: 8:55am, 6 September 2024
Ben KempSeptember 11, 2024