Regulation
Brexit: what it means for UK market access
On 26 June 2022, the MHRA published its response to the consultation on the “future regulation of medical devices in the UK”, indicating future change for UK medical devices regulation going forward. Five pillars on which the UK MDR will be based upon, were established: l Strengthening MHRA power to act; l Making the UK a focus for innovation; l Addressing health inequalities and mitigating biases throughout medical device product lifecycles;
l Proportionate regulation which supports businesses through access routes that build on synergies with both EU and wider global standards;
l Building the UKCA mark as a global exemplar.
Initially, UK MDR was due to be implemented in July 2023, but there is no clear sight, as of yet, for what or when the UK regulatory requirements will be implemented. Transitional arrangements to the UK MDR
are required to facilitate supply of devices to Great Britain under the transition measures and devices may be placed on the Great Britain market with a CE mark under the following timelines3
:
l General medical devices compliant with the MDD or AIMDD with a valid declaration and CE marking can be placed be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028.
l In vitro diagnostic medical devices (IVDs) compliant with the IVDD can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030.
l General medical devices, including custom- made devices, compliant with the EU MDR and IVDs compliant with the IVDR can be
User needs
Design input
Design process
Verification
Design output
Medical device
Validation
Figure 1 – The design and development pathway for a typical design control process (Adapted from:
https://www.iso.org/publication/PUB100422.html)
placed on the Great Britain market up until the 30 June 2030.
Low risk Class I medical devices e.g. wheelchairs, spectacles, and general IVDs e.g. instruments and specimen receptacles under EU MDD or IVDD, for which the conformity assessment did not require a Notified Body, can only be placed on the Great Britain market if the involvement of a notified body would be required under the EU MDR or IVDR. The Government intends to introduce legislation later this year to strengthen post- market surveillance requirements, prior to the framework’s implementation. Presently, the emphasis is on more stringent requirements, tighter timelines, information to be covered for PMS systems including trend reports, FSCAs and new requirements for custom made devices – expected to apply from mid-2024. As of March 2024, there are 9 UK Notified
Bodies certified for UKCA accreditation, but this is under the current UK MDR framework, for whom all vary under their certification capabilities. Notified Bodies cannot certify under the new requirements, as these do not yet exist, but not many have yet taken up UKCA certification duties compared with the EU.
Designing a medical device: key considerations 1. Understanding the landscape - Designing a medical device can be a complex process with several factors to consider and multiple intricacies encased. An in-depth understanding of the medical industry, including the product specifics, the design requirements and the ever-evolving regulations is a must.
2. Importance of robust Design Control - Early
on in the feasibility of your device after market analysis, you should be thinking about a good robust design control process. As a consultancy, we have seen many times that companies have fantastic ideas or products but have no proper design and development process to control the design of their device, or the key principles of a Quality Management System (QMS). This will cause delays in the launch of your device and will make all the difference in the effectiveness and efficiency of delivery. Bringing in the correct expertise early on will not only aid with bringing your device to market efficiently, but will also stop potential risks of things going wrong.
3. Design and Development Process - Following ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes. A typical design and development process cycle will include many design stages, including Design and Development Planning, Design Inputs, Design Outputs, Verification and Validation, Product launch, Post Market and Design Changes. The design and development process,
shown in Figure 1, offers a traditional model in which design and development proceeds in a logical sequence of phases or stages. To put it simply, it is users’ requirements that are developed, and a medical device is created to meet those user requirements. The medical device is then verified and validated, transferred into production, and the medical device is manufactured and ready for access into the marketplace.
In practice, feedback pathways are necessary between each phase of the process and previous phases, representing the iterative
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