New MDR regulation, Brexit and a global pandemic presents medical device challenges
New MDR regulation, Brexit and a global pandemic presents medical device developers and manufacturers with a trio of concurrent challenges.
However, delays to implementation of European Union law presents a limited window of opportunity in new product development. Acting urgently could accelerate essential evidence gathering, especially for low-risk medical device software.
“Brexit and a global pandemic presents medical device developers and manufacturers with a trio of concurrent challenges.”
The trio of challenges.
transition after leaving the EU in January involves the UK abiding by EU law until December 2020, including application of the CE mark to medical devices.
2. Medical Device Regulation
(MDR), which had been due to become EU law on 26 May 2020 has subsequently been delayed by a year. The Medicines and Healthcare Products Regulatory Agency (MHRA) is yet to confirm whether the UK extension will match that in the EU, or UK manufacturers will have to comply earlier, at the end of transition.
impacts were cited as grounds for the delay – although many commentators suspect that a general lack of readiness made this year’s deadline an impossibility to enforce.
Acting now provides some device developers a unique opportunity to gather critical clinical evidence and build a better business case, faster and at lower cost than in future.
Medical device app development is particularly affected by the MDR. Under the soon to be superseded MDD, many apps are treated as medical devices and fall into the lowest risk category, class 1. With the right evidence, the organisation offering these devices for use can self-certify conformity with relevant law and regulations and apply the CE mark.
MDR Rule 11 now treats virtually all medical device software as class 11a or above. Irrespective of any risk of harm. A notified body (such as BSI) must be involved in pre-market and subsequent audit, increasing costs significantly.
The EU’s delay in MDR enforcement means medical device manufacturers now have until 26 May 2021 to make new self-declarations of conformity to the EU Medical Device Directive (MDD). For class 1 products destined for the UK market, we may only have until December.
MDR clinical evaluation requirements exclude previously acceptable claims of equivalence to “on the market” devices, so more costly clinical investigation (trials) will be necessary.
The MDR also impacts organisational quality management systems and resilience. A new requirement for employment of a “qualified person responsible for regulatory compliance” to navigate the additional complexity is perhaps unsurprising!
MDR compliance burdens now present a significant challenge to business viability for many not-for-profit, spin-out and start-up organisations that may be relatively cash-poor, but often at the forefront of innovative healthcare app development.
Even well-resourced organisations face problems. Pre-pandemic, a severe shortage of notified body capacity was already delaying medical device and organisational quality management system audits. Covid-19 has now halted or delayed many of the clinical investigations essential to MDR compliance.
Getting back to normal will not be easy.
In many trials, staff, patients and potentially device designs and use protocols will be impacted by elevated infection prevention protocols.
Software-based innovation in remote monitoring, diagnosis and therapy could help deliver contact-free, home-based, patient self-administered healthcare, overcoming heightened infection prevention concern.
Unfortunately, devices that could significantly reduce risks of harm in healthcare now face regulatory hurdles that could delay their introduction.
Delay to the MDR offers an opportunity
Where classification permits, self-certifying now under the MDD could enable accelerated gathering of new evidence required for the MDR, outside of clinical investigation. In the UK, the more restricted window of opportunity to act (than in EU nations) means manufacturers should consider taking urgent action.
Structured observation and user-feedback can provide important near-to-real-use, or real-use data. As healthy volunteer studies using CE marked products often do not require ethical approval, CE marking under the MDD could accelerate evidence gathering.
Alternatively, a “soft” or full launch under MDD, could be used to gather post-market surveillance and/or post-market clinical follow-up data that contributes to a subsequent MDR CE audit by a notified body, or an MDR compatible self-declaration of conformity.
Adapt business models
Many medical device spin-outs and start-ups spend a lot of management time and budget implementing medical device quality management systems early in the business cycle.
Medical device regulatory compliance is not straightforward. Systems can appear burdensome and inappropriate to the needs of embryonic businesses, when limited management resources could be more productively directed elsewhere.
Partnering with Lucid to develop your compliance planning will deliver significant efficiencies.
Focus, a new service from Lucid, enables aspiring medical device manufacturers to exploit the experience of our team in developing your ISO 13485 system. Driven by lean, light-touch principles, we can co-create a tailored quality management system, matching business, and compliance needs.
Options include initial manufacturing at Lucid and training a person responsible for regulatory compliance. Together we can build up confidence; testing and transferring the quality management system into the business in stages when it makes sense.
For more information please contact us on +44 161 860 0058 or email firstname.lastname@example.org
Carl Stone, Lucid Group Creative Director
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