50th Notified Body Designated Under the EU MDR Hungary-based Notified Body ‘NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC)’ has been notified as the 49th Notified Body under the EU MDR. 50th Notified Body Designated Under the EU MDR
DSIT Announce New Regulatory Innovation Office The Department of Science, Innovation, and Technology (DSIT) has announced the launch of the new Regulatory Innovation Office (RIO). The RIO’s primary goal is to reduce red tape and accelerate public access to emerging technologies, supporting economic growth in the process. DSIT Announce New Regulatory Innovation Office
MHRA AI Airlock Pilot MHRA has announced their AI Airlock pilot is open for applications. The application is open for 2 weeks, until 7 October 2024, and MHRA is encouraging applications from innovators and developers of AI medical device products and prototypes to come forward. MHRA AI Airlock Pilot
MHRA Control Testing Guidance Updates Published MHRA has published updates to the following control testing guidance to reflect the requirements of the Windsor Framework. MHRA Control Testing Guidance Updates Published
Med Tech Regulations Blog Post Published MHRA has published the latest blog from Laura Squire OBE, where she shares an update on the programme of regulatory changes for medical devices. Med Tech Regulations Blog Post Published
Extended Producer Responsibility (EPR) Regulations for Packaging Update Defra has provided an update on the legislation for the introduction of Extended Producer Responsibility (EPR) reforms for packaging. Extended Producer Responsibility (EPR) Regulations for Packaging Update
DBT Webinar on The Product Regulation and Metrology Bill DBT is running a informative webinar on the Product Regulation and Metrology Bill on Thursday 10 October. DBT Webinar on The Product Regulation and Metrology Bill
MHRA Clinical investigations Guidance Update MHRA has updated the guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices to reflect changes to the process listed under the Amendments/modifications section. MHRA Clinical investigations Guidance Update
PAGB Food Supplements Regulatory Workshop The upcoming PAGB Food Supplements Regulatory Workshop will take place in person on Thursday, 10 October, at PAGB's office from 10:00 AM to 4:00 PM. PAGB Food Supplements Regulatory Workshop
Application Route for Performance Studies Under the In Vitro Diagnostics Regulations in Northern Ireland The MHRA has announced the approval of the first application for In Vitro diagnostic devices under the EU IVDR in Northern Ireland due to recent implementation of a submission route for manufacturers for performance studies. Application Route for Performance Studies Under the In Vitro Diagnostics Regulations in Northern Ireland
MHRA Strategy for Improving Safety Communications 2024 – 2027 MHRA has published their 3-year strategy for improving safety communications for 2024 to 2027. The strategy sets out MHRA’s ambition to transform the way they communicate about the risks and safety of medicines, medical devices and healthcare products in the UK to support effective implementation of new safety measures. MHRA Strategy for Improving Safety Communications 2024 – 2027
MHRA Data Strategy 2024 – 2027 Published MHRA has published its its data strategy 2024-2027. MHRA Data Strategy 2024 – 2027 Published
