A new horizon for medical devices regulation in the UK 22 Sep 2021
Medical devices play a critical role in healthcare delivery, and from contact lenses to thermometers, many of us use them daily. During the pandemic, medical devices have come increasingly to the fore, particularly with the demand for validated diagnostic tests to be brought to market quickly. While often receiving fewer news inches than pharmaceutical topics, the sector is active, with several trends influencing the landscape.
One significant development on the horizon is regulatory change. In January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) struck out as a post-Brexit independent regulatory body. Since then, they have introduced various initiatives to support innovation and streamline research, including the Innovative Licensing and Access Pathway scheme (ILAP) to help accelerate the delivery of new therapies to patients. Now, the MHRA is turning to a transformation of medical devices regulation and plans to leverage its independent status and reshape the approval process.
Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002. This structure is set to change, with the launch of a 10-week consultation, soliciting experiences and views from the public- including ‘patients, medical device researchers, developers, manufacturers and suppliers, clinicians, other healthcare professionals’ to inform a new era of medical devices regulation in a post-Brexit UK.
The government’s documentation states that its objective is to create a framework that improves patient and public safety, increases transparency in regulatory decision-making, and aligns with global best practices. They also note that they wish to create ‘more flexible, responsive and proportionate regulation’ of medical devices.
This latter statement chimes with the sentiments of the Taskforce on Innovation, Growth and Regulatory Reform report, which we discussed in August. The report’s parliamentary authors recommended that innovation be embedded at the heart of regulatory frameworks while ensuring protections with ‘simple, agile, and proportionate’ regulations.
Of the news, Sajid Javid, the Secretary of State for Health, commented that “This consultation will allow us to revolutionise the regulation of medical devices, making sure our pioneering life sciences sector can continue to lead the world and safeguard the health of our nation.”
The consultation certainly is wide-ranging and ambitious in its scope, tackling areas including post-marketing surveillance, clinical investigations, in vitro devices, software devices, and implantable devices, along with exploring routes to market and addressing sustainability issues.
Among the potential initiatives under consideration are introducing new pathways for medical devices to be placed on the market in the UK, strengthening scrutiny for implantable devices, and requiring unique device identifiers (UDI). Dr June Raine, Chief Executive of the MHRA, also noted an opportunity to broaden the agency’s oversight. She said, “It is also an opportunity to impact what products the MHRA regulates – for example, should the MHRA have a role in the regulation of other products which are similar to medical devices such as cosmetic coloured lenses or dermal fillers?”
The resulting regulatory amendments will be introduced at the beginning of July 2023, and the consultation will be open until 25th November 2021.
You can learn more and respond to the consultation at the government and MHRA links below:
PharmaMedic supports clients in the medical devices sector with regulatory and medical affairs solutions. To arrange an initial discussion contact us here.