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…
New MHRA appointment to help accelerate patient access to innovative medical devices
The UK Government has announced the appointment of Lawrence Tallon as Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency (MHRA). Following an…
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…
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…
MHRA seeks views of researchers, suppliers and users of medical devices to inform future regulation
People are being encouraged to contribute their views to a public Medicines and Healthcare products Regulatory Agency (MHRA) consultation on changes to how medical devices…