AI Airlock, CERSIs and a new global AI network for health regulators

Posted by: , Posted on: - Categories: AI Airlock

Marinos Ioannides, Head of Software and AI Medical Devices: If you’re anything like me, Summer in Britain is a season of transformation and hope. Gone are the frozen, damp morning dog walks in darkness. Coats and jackets are locked away, half-empty half-forgotten …

MedTech regulatory reform and the importance of partnerships

Posted by: , Posted on: - Categories: Med Tech Regulations

Medical technologies will play a critical role in delivering the government’s 10 Year Health Plan and its three shifts: hospital to community; analogue to digital; and sickness to prevention. Risk-proportionate regulation, which ensures patient safety whilst supporting innovation and access, …

ICH M15 Model Informed Drug Development (MIDD) Guideline

Posted by: , Posted on: - Categories: Model informed Drug development (MIDD)

The International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) Guideline has reached Step 2b and is available for public consultation.  As a clinical pharmacology assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I was …

An update on our plans for Med Tech regulatory change

Posted by: , Posted on: - Categories: Med Tech Regulations, Medical Devices

Our external engagement on the programme of regulatory changes for medical devices has re-started in earnest this week following the pre-election period and early discussions with new ministers. Bilateral meetings with Trade Associations have begun again, we are speaking at …