Medicines and Medical Devices Reform – MHRA launches consultation to improve safety of medicines and medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation reviewing engagement with healthcare professionals to improve the safety of medicines and medical devices.

The consultation’s objective is to ensure that healthcare professionals receive actionable guidance and information on the safe use of medicines and medical devices in order to provide timely and informed advice to patients.

Scope of Consultation

The MHRA seeks to improve safety communication channels and safety reporting systems with healthcare professionals. The feedback sought focusses on 4 key areas:

• safety reporting systems;
• MHRA advice and regulatory decisions;
• awareness and understanding of the MHRA’s safety role; and
• how easy it is for healthcare professionals to share their views and expertise with the MHRA.

Engagement between the MHRA and healthcare professionals is crucial in helping get safe and effective medicines and medical devices to patients, in ensuring that patients are adequately informed of the benefits and risks and that safety concerns are reported and can be acted on quickly. The MHRA states that the views expressed during the consultation will support healthcare professionals to deliver the best care to patients. The MHRA seeks to learn from the experiences of healthcare professionals to able to tailor MHRA’s engagement most effectively.

The deadline for responses is 11:45pm on 18 January 2023.

The consultation is by way of an online survey. The consultation survey can be found here.

HOW WE CAN HELP

Our team of regulatory and commercial experts regularly advise clients on the medical device regulatory framework, including commercialisation, manufacturing and distribution arrangements. Should you wish to discuss any issues relating to medical device regulation, please contact Vincent Buscemi or Louise Brennan.