December 2024 – Medical Devices Regulatory Insights

UK Medical Device Regulator MHRA Announces Legislative Updates The Post-market Surveillance (PMS) Statutory Instrument (SI) laid in Parliament on 21 October 2024 was the first major update to the framework of medical device regulations in Great Britain. Since January 2021 all medical devices have been required to be registered with the MHRA before they can…

Creating a Regulatory Roadmap for MedTech Market Success with Etienne Nichols

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Adnan Ashfaq of Simplimedica, a seasoned quality, regulatory, and validation specialist, to explore the critical role of developing a regulatory roadmap for medical device companies. Adnan breaks down the differences between a regulatory strategy and a regulatory roadmap, highlighting how a…

September 2024 – Medical Devices Regulatory Insights

UK Medical Device Regulator MHRA Announces Legislative Updates The MHRA, the UK medical device regulator, gave a progress report on the agency’s work toward completing its roadmap of medical device legislation. On September 18, Robert Reid, Ph.D. Deputy Director, Innovative Devices at the MHRA, updated the RAPS audience on the current status of the UK…

Free Webinar – Process Validations: an overview

Free Webinar – Process Validations: an overview

Process Validation is a subject area that is not often discussed in webinars and an area left to engineers to figure out for themselves and to learn on the job. Still, there is some guidance and best practice in validation. Over the coming weeks and months we will be looking at: Adnan Ashfaq is a…

July 2024 – Medical Devices Regulatory Insights

MHRA announces a proposed framework for international recognition of medical devices The Medicines and Healthcare products Regulatory Agency (MHRA) on 21 May 2024 published a statement of policy intent for international recognition of medical devices. The MHRA’s statement of policy intent describes how the UK Government intends to recognise regulatory approvals from Australia, Canada, the…

April 2024 – Medical Devices Regulatory Insights

Update from MHRA on UK MedTech Regulatory Reform The UK medical device regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), presented a webinar (March 5) on the upcoming changes to the medical devices legislation for Great Britain (GB). The webinar provided an update on the draft policy on scope, classification and essential requirements for…

January 2024 – Medical Devices Regulatory Insights

MHRA sets out a new Roadmap to protect patient safety and allow access to medical technology including AI and diagnostics. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a roadmap for developing new and robust regulations for medical devices in the UK and are designed to provide greater international harmonisation. Access roadmap for 2024/2025…

Medical Device Consultant service for your support

In this podcast, Adnan Ashfaq (Simplimedica) met with Monir El Azzouzi (Easy Medical Device) at Medica 2023 in Dusseldorf, Germany to discuss the current challenges regarding medical device regulation.

October 2023 – Medical Devices Regulatory Insights

Medtech Could Help Address EU’s Worsening Healthcare Workforce Crisis Belgium, when it takes over the presidency of the Council of the European Union in January 2024, intends to make the EU’s worsening healthcare workforce crisis “one of the main priorities at the EU level for the upcoming years and the next Commission.”. That is according…

August 2023 – The MDR is Dead!

Did that headline catch your attention? I thought so. Well is the MDR indeed dead or is it even alive? Since February 2023 there has been a serious drop in MDR activity, while many MDR gurus are still organising conferences discussing the regulations in a desperate attempt to keep the industry engaged, much of the…