MHRA launches public consultation on future of medical device regulation
Launched today by the Medicines and Health Products Regulatory Agency (MHRA), the 10-week consultation gives everyone the opportunity to draw on their own experiences and contribute to improving the regulatory framework and therefore patient safety in the future.
From hearing aids and walking sticks to insulin pumps and thermometers, for many of us, medical devices are an integral part of our daily lives. We all want to know that the devices we use are safe and effective, so the regulation of medical devices is really important, especially where rapidly developing technology has changed and continues to influence the medical device landscape, bringing new innovative devices to the UK Market, including some healthcare applications.
The MHRA is the regulatory body for medical devices used in the UK. We seek the views of all sectors of medical device and healthcare, physicians, patients and the general public, to inform our future approach. We would like to hear from those who research, manufacture, supply and use medical devices.
Medical devices in the UK are currently regulated by the Medical Devices Regulations 2002. Following the UK’s departure from the European Union, the MHRA now has the ability to create a premier regime that prioritizes safety patients while encouraging innovation, including streamlining the approval of Medical Equipment.
This consultation is comprehensive – covering a wide range of regulatory issues – from requirements for the conduct of clinical investigations, to how devices are assessed before they are placed on the market, to the obligations of importers and distributors and from post-marketing surveillance to transparency and the role of patients. It offers a unique opportunity to ensure the safety and quality of the medical devices that many of us rely on and from which we all benefit.
Dr June Raine, Executive Director of the MHRA, says:
The launch of this consultation is an exciting step towards a more robust and world-class regulatory framework for medical devices in the UK, one that improves the safety and quality of medical devices, access to devices and is at heart the patients.
We know that a problem with a medical device can have a big impact on people’s lives. This consultation offers a unique chance to help shape regulation. In order to achieve this goal, we want to hear from a wide range of people. The delivery of patient services is at the heart of our work and we fully recognize the importance of public and patient perspectives and encourage them to share their views during this consultation.
This is your chance to make a difference in people’s experiences with devices by helping to shape medical device regulations – from the scrutiny they face before they go to market, to how they are. tracked and monitored, and what actions are taken if problems with a device arise. This is also an opportunity to have an impact on the products that the MHRA regulates – for example, should the MHRA play a role in the regulation of other products similar to medical devices such as cosmetic colored lenses or dermal fillers?
We encourage everyone to share their perspective on the future of medical device regulation through this public consultation.
Health and Social Affairs Secretary Sajid Javid said:
The UK is home to one of the world’s most renowned regulators, ensuring the safety and efficacy of the medicines and medical devices we all rely on.
This consultation will allow us to revolutionize the regulation of medical devices, ensuring that our pioneering life sciences industry can continue to lead the world and protect the health of our nation.
From pacemakers to contact lenses, wheelchairs to pregnancy tests, medical devices play a vital role for the vast majority of us and I encourage all who wish to be a part of this mission to make their point. seen.
The consultation will end on November 25, 2021 at 11:45 p.m.
We have already hosted two webinars in October, one aimed at industry and the other focused on patients and the general public. The webinars provided more information on the background and scope of this consultation and how to respond to it. Both webinars have been recorded and the video recording will be posted on Gov.UK in due course.
Notes to editors
The Medicines and Health Products Regulatory Agency is responsible for regulating all medicines and medical devices in the UK.
The MHRA is a center of the Medicines and Health Products Regulatory Agency which also includes the National Institute of Biological Standards and Controls (NIBSC) and the Clinical Practice Research Data Link (CPRD). The MHRA is an executive agency of the Ministry of Health and Social Affairs.
This consultation is about a future UK-wide program to regulate medical devices. He acknowledges that the government is seeking a new balance for the Northern Ireland Protocol in order to place it on a more sustainable basis, as developed in its command document – Northern Ireland Protocol: the way forward .
Under the current Northern Ireland Protocol approach, EU medical device rules continue to apply in Northern Ireland. The EU Medical Device Regulation (2017/745) (EU MDR) therefore entered into force in Northern Ireland on May 26, 2021 and the In Vitro Diagnostic Medical Device Regulation (2017/746) (EU IVDR) will enter into force on May 26, 2022. EU MDR and EU IVDR will not apply in Great Britain. We welcome views on alignment across all UK countries as part of this consultation. The government is also looking to rebalance the protocol and, as stated in its command document, has proposed a dual regulatory regime in Northern Ireland, where goods that comply with UK or EU rules could move into Northern Ireland. .
For all other inquiries regarding this consultation, please contact [email protected]