MHRA’s proposed Early Access route aims to put breakthrough medical devices in patients’ hands sooner
The Medicines and Healthcare products Regulatory Agency (MHRA) has released a Statement of Policy Intent that details its proposals for how an Early Access Service…
MHRA will consult later this year on the indefinite recognition of CE-marked medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced important new steps to secure access for patients to the latest medical technologies available in…
Insight: Why active mattress compliance is now a legal and moral obligation
Gary Baker, Medical Devices Director at Squirrel Medical Gary Baker, Medical Devices Director at Squirrel Medical, outlines the tightening regulatory landscape surrounding active mattresses, where…
Proposed MHRA framework aims to reduce duplication of medical device assessments internationally
Yesterday, the Medicines and Healthcare products Regulatory Agency (MHRA) published a statement of policy intent for international recognition of medical devices, which includes some assistive…
New mechanism to report safety concerns with healthcare products in Northern Ireland
A new regional centre that promotes the reporting of suspected safety concerns associated with healthcare products has been launched in Northern Ireland. The Yellow Card…
UK patients set to have faster access to innovative medtech backed by £10m funding
The Innovative Devices Access Pathway (IDAP) pilot has been launched, supported by £10 million UK Government funding, which is designed to support the rapid development…
New regulatory pathway set to support safe patient access to innovative medtech
The Medicines and Healthcare products Regulatory Agency (MHRA) is set to launch the Innovative Devices Access Pathway (IDAP) later in 2023. IDAP is designed to…
Government announces multi-million-pound funding for medtech sector
Chancellor of the Exchequer Jeremy Hunt | Credit: Wikimedia Commons Chancellor of the Exchequer Jeremy Hunt has unveiled £650 million to “fire up” the UK’s…
Manufacturers given more time to get certain medical devices CE certified
The EU has taken steps to give manufacturers more time to get certain medical devices, which includes certain assistive technologies, certified under the EU Medical…
UK medical devices regulation: What the assistive tech sector needs to know about MHRA’s plans
Medicines and Healthcare products Regulatory Agency (MHRA) has published important new plans about the future of medical devices regulation in the UK, which are designed…