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…
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…
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.
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…
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…
MDCG Recommends Limits on Article 97 MDR Applications by EU Member States European regulators are recommending that European Union member states should limit the use of Article 97 Medical Devices Regulation (MDR) to particular circumstances involving legacy medical devices now that amendments extending MDR transition periods have been published. On July 1, 2023 the Medical…
With medical device regulations tightening worldwide, especially in Europe, it’s important to assess the changes unfolding across the global regulatory landscape to fully understand how it impacts your business and product. In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape,…
MHRA Consultation on the future of regulating medical devices in the UK The UK Medicines and Healthcare products Regulatory Agency (MHRA) invites members of the public including patients, developers, manufacturers, suppliers, healthcare professionals and members of the wider public to provide their views regarding possible changes to the regulations for medical devices in the UK….
If you are developing Medical Device software then IEC 62304 is an important standard for you. In this episode, Monir El Azzouzi invited Adnan Ashfaq from Simplimedica to explain to us what is this standard. He will also mention some key links to the EU MDR 2017/745 and to other standards. Here are some of…
Process Validation is a science but it needs also some education. In this episode of the Medical Device Made Easy Podcast, we will help you understand what is Process Validation. If you are a Medical Device Manufacturer or if you are an engineer who wants to understand Process Validation, then this episode is for you….