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Digital Technology Innovation and Medical Devices
UK proposes £3.5 billion of funding and innovative new device pathways for Medical Devices and Digital Health incorporating Artificial Intelligence The UK government is currently looking at reforming the UK regulatory system for medical devices, to increase the...
Key steps to Post-Market Surveillance (PMS)
Medical device businesses need to stay on top of their Post-Market Surveillance activities at all times. There are some specific areas to focus on to help ensure that PMS is up to date and thorough, in this blog IMed Consultancy shares some must-monitor areas for...
Medical Device Global Market: Expanding into Asia-Pacific (APAC)
Daniel English, Regulatory Affairs Consultant at IMed Consultancy provides valuable insights in this first short article of a 3-part series. Are you a UK or EU Manufacturer with a medical device already approved in the UK or EU? Have you recently CE Marked a lower...
PMS and patient safety: shifting to a proactive approach
Despite deadlines for the EU MDR 2017/745 and the EU IVDR 2017/746 (IVDR) implementation being pushed back once more, certain aspects of the MDR that are closely linked to patient safety, such as the need for cyclical and proactive Post Market Surveillance (PMS), are...
Countdown to the final UK MDR: changes Importers and Distributors need to be aware of
The final UK Regulation text is due to be published from Spring 2023, and new Post-Market Obligations must be implemented by Importers and Distributors providing UKRP services in 2023. New UKRP rules for Importers and Distributors The most critical change...
Compassionate Use and Temporary Use of a medical device
Easement or relaxation of certain regulatory requirements Relaxation of certain regulatory requirements (‘easement’) was well recognized and utilized for devices (e.g., masks, gloves, ventilators) and IVD’s such as lateral flow tests during the earlier phases of the...
The new UK Medical Device Regulation is due soon: is your appointed UKRP ready?
The final UK Regulation text is scheduled to be published from Spring 2023, so manufacturers should be assessing their current provider to ensure they meet the compliance requirements to keep their devices in the UK market. UK MDR: new requirements for UKRPs and...
Medical Device Field Safety Corrective Actions
EU lay of the land Medical devices, like all products can potentially go wrong. Robust processes are usually in place at manufacturing organisations to help prevent safety problems, but even the best designed product can be found later to have unexpected design or...
Switzerland’s Parliament Moves to Accept FDA approved Medical Devices
On the 28 Nov 2022, Switzerland’s Parliament took a decision to instruct the Federal Council to incorporate the acceptance of medical devices approved by the United States (US) Food and Drug Administration (FDA) into national law. In recent months Switzerland...