The Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s regulating authority, has initiated a public consultation regarding the regulatory framework for medical devices. In particular, the authority encourages medical device manufacturers and other parties involved in operations with medical devices to provide their feedback and suggestions with regard to future changes to the applicable regulatory requirements. The authority additionally emphasizes the importance of ensuring the safety of patients, transparency in the sphere of information and decision-making processes, harmonization with best practices, and additional flexibility for the regulatory framework in general. The scope of activities related to the consultation includes online surveys and webinars intended to provide additional information regarding the subject of the consultation.
First, the MHRA explains the idea behind the attempt to improve the existing regulatory framework for medical devices and outlines the main goals to be achieved. In particular, the changes would be introduced by amending the Medical Devices Regulations 2002, the primary piece of legislation establishing the rules and requirements in the sphere of medical devices. The authority also mentions that starting from July 2023, CE marking would be no longer admissible for medical devices intended to be marketed in the country – it would be necessary for the device to have a valid UKCA marking. Hence, the authority intends to implement the regulatory changes described herein till that time. When preparing the initial materials for the present consultation, the MHRA has considered the proposals received from all the parties involved in operations with medical devices.
As stated by the MHRA, the safety of patients remains the main purpose of the future development of the regulatory framework. The authority intends to ensure that healthcare professionals and patients have timely access to efficient, safe, and innovative medical devices. Consequently, it is important for the authority to establish a proper balance when creating favorable conditions for medical device manufacturers intending to place their products on the market by reducing the unneeded regulatory burden while also ensuring the safety of patients. According to the consultation paper, the authority intends to widely adopt international best practices and standards in order to align national legislation in the sphere of medical devices with the most advanced legislation adopted in other jurisdictions in order to improve the protection of patients and also simplify the process of entering the market for foreign medical device manufacturers.
Thus, in order to achieve the goals described above, the MHRA intends to:
- Develop and introduce new special pathways and frameworks for innovative products in order to created favorable conditions for medical device manufacturers employing novel technologies in their products, and also to make such products available for the patients;
- Create a unique, innovative, and ambitious framework for regulating software and artificial intelligence as medical device;
- Improve existing regulatory framework for in vitro diagnostic (IVD) medical devices by making changes to the applicable classification, and also making other steps based on the experience of regulation of IVD medical devices widely used in the context of the COVID-19 outbreak;
- Establish an efficient regulatory framework for re-using and re-manufacturing medical devices.
As mentioned, the new legislation is planned to become effective starting from July 1, 2023. However, to ensure uninterrupted access to vitally important medical devices and avoid shortages in supply, transitional rules will be implemented to provide medical device manufacturers and other parties involved in supplying medical devices with additional time to achieve compliance with the new regulatory requirements. The authority additionally emphasizes the increasing role of guidance documents as an important instrument by virtue of which the authority will provide recommendations and suggest approaches to be applied. While being non-binding in their nature, these guidance documents will be useful for medical device manufacturers and other parties due to additional clarifications contained therein. The authority expects such an approach would provide additional flexibility in comparison to the use of only the instruments containing rules and requirements the parties involved should follow.
Introduction to Public Consultation
Apart from the main goals described above, by amending the regulatory framework, the MHRA also intends to expand the engagement of patients in all processes associated with the development of medical devices. The appropriate consultation dedicated to the aspects related to patients’ involvement has already been carried out by the authority, while the present consultation is mostly focused on the questions related to ensuring the safety of patients.
As mentioned, medical devices marketed in the UK are currently subject to regulation under the Medical Devices Regulations 2002, which is aligned with the respective regulatory requirements set forth by the EU’s Directives. In the context of further improvement of the European regulatory framework – in particular, implementation of the new Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) – UK’s existing regulatory framework becomes outdated and no longer meets the newest standards and approaches. Hence, the MHRA intends, by virtue of the amendments to be discussed during public consultation, to improve the national legislation. The appropriate function of the MHRA is prescribed by Chapter 3 of the Medicines and Medical Devices Act, which entitles the MHRA to make amendments to the applicable legislation in the sphere of medical devices.
It is also important to mention that Northern Ireland has already implemented the aforementioned Regulations: the MDR is effective as of May 26, 2021, and the IVDR will enter into force on May 26, 2022. The appropriate protocols will be developed and implemented in order to ensure access to medical devices in the context of different regulatory frameworks. While the present consultation is dedicated to the new UK-wide improvement of the national legislation, it also addresses some aspects related to special protocols to be introduced in order to ensure compatibility of the regulatory requirements.
The new consultation announced by the MHRA contains 15 chapters each dedicated to a specific aspect, namely:
- Chapter 1 outlines the scope of the regulation;
- Chapter 2 describes the suggested changes to the classification of medical devices;
- Chapter 3 highlights the main points related to the requirements the parties involved should comply with;
- Chapter 4 addresses the aspects related to registration and UDI;
- Chapter 5 is dedicated to Approved Bodies designated to carry out conformity assessment;
- Chapter 6 describes conformity assessment itself;
- Chapter 7 outlines the regulatory requirements in the sphere of clinical investigation/performance studies;
- Chapter 8 address the matters related to post-market surveillance, vigilance, and market surveillance;
- Chapter 9 is dedicated to IVD medical devices;
- Chapter 10 describes the regulatory approach to Software as a Medical Device;
- Chapter 11 deals with Implantable Devices;
- Chapter 12 highlights other product-specific changes to regulations;
- Chapter 13 covers the aspects related to environmental sustainability and public health;
- Chapter 14 describes the new pathways;
- Chapter 15 is dedicated to the transitional regime rules.
In summary, the present consultation commenced by the MHRA describes the suggested changes to the regulatory framework for medical devices. By virtue of the consultation, the authority describes the approach it is going to apply and encourages the parties involved to provide their feedback and suggestions.
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