The UK MHRA is consulting on the future regulation of medical devices in the UK.
- Powers in the Medicines and Medical Devices Act (2021) allow the MHRA to amend the Medical Devices Regulations 2002 which govern medical devices regulation in the UK.
- Amendments to create the new regime are scheduled to be in force at the beginning of July 2023 to align with the date from which the MHRA is due to stop accepting CE marked medical devices in Great Britain and will require the use of the UKCA marking.
- The scope of this consultation has been informed by early engagement with a range of stakeholders and it sets a series of proposals which can help the MHRA make the UK the most attractive place to research, develop, produce, and supply safe and innovative medical devices.
What is the purpose of the consultation?
The MHRA is inviting members of the public to provide their views on possible changes to the regulatory framework for medical devices in the UK, in order to develop a future regime for medical devices which enables:
- Improved patient and public safety;
- Greater transparency of regulatory decision making and medical device information;
- Close alignment with international best practice, and;
- More flexible, responsive and proportionate regulation of medical devices.
What will be the purpose of the new legislation that will evolve from the consultation?
The purpose will be to protect and improve patient health by enabling the earliest access to, and high-quality supply of, safe, effective and innovative medical products through proportionate, data-driven assessment of risks and benefits.
How will the new legislation support the UK government’s ambition?
The regulatory environment will need to support the Government’s ambition to be at the forefront of medical device innovation and adoption. In many areas, gaining and maintaining competitiveness in a global market will be best supported by alignment with internationally recognised best practice and standards.
How will the new regulatory regime propel the UK medical devices sector forward?
With this bold new regulatory regime, the intention is to propel the UK medical devices sector forward in several significant areas through:
- creating new access pathways to support innovations ensuring that the UK remains an excellent place to launch new medical devices and avoid repeat assessments, granting early patient access to novel treatments whilst maintaining robust safety standards and capitalising further on the UKs global reputation for R&D and the NHS
- a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical devices. This leading regulatory model will address many challenges ahead of international peers, ensuring that it attracts a world-class life sciences industry and innovators without compromising on safety;
- reforming in vitro diagnostics (IVD) regulation to update classification and include an extended patient risk review, recognising the central role that diagnostic devices have played in the UK response to the COVID-19 pandemic;
- becoming a sustainability pioneer through the safe re-use and re-manufacture of medical devices, offering a substantial opportunity to reduce single-use medical devices, help reach the Government’s Net Zero target, support the Greener NHS Initiative, and improve supply chain resilience.
The new regulatory framework will be designed to boost patient safety and support the continued growth of the MedTech and diagnostics sector across the whole of the UK.
When will the new medical devices regulations come into force?
The Regulations will come into force on 1 July 2023 with appropriate transitional arrangements.
The belief is that these timescales will deliver benefits at pace, whilst providing industry time to adapt to meet the requirements in future regulations.
What are the consultation start and end dates?
The consultation will run for a period of ten weeks.
Start date: 16 September 2021
End Date: 25 November 2021
Where can you find the consultation documents?
This consultation is comprehensive and covers a broad range of regulatory issues, from requirements for running clinical investigations, to how devices are assessed before being placed on the market through to importer and distributor obligations and post-market surveillance to transparency and the role of patients. There are 14 Chapters, each with its own list of possible changes, focusing on improving patient safety and/or on aligning with international best practice. Each chapter also has its own list of questions to be answered.
An overview of the fourteen chapters is available here.
The consultation documents are all available here.
Where can you respond to the consultation?
You can respond to the consultation here.
Do you have to respond to every question in the consultation?
There is no obligation to answer every question. For those with less time or those who have less technical knowledge but who wish to participate, there is short set of overarching questions which can be completed alone or in combination with any other questions from the more technical set.
Before you respond to the consultation
Before you respond to the consultation, you may want to watch the two webinars from the MHRA which set out some background to this consultation – one aimed at industry, and one aimed at the wider public. You can view them under the heading Consultation webinars on this page.
How will the MHRA use the results of this consultation?
The MHRA will use the results of this consultation to inform the development of its future regulatory regime. The plan is to publish secondary legislation to update the UK medical devices regulations and thus implement a new regulatory framework for devices in the UK.
Source: MHRA website