MEDICAL DEVIC E S
familiarise themselves with any new controls and procedures, and to stay abreast of new developments by following information from the relevant authorities.
Planning ahead
Manufacturers must make sure they take full advantage of the transition period, ahead of the 2023 deadline. To begin with, it is important to remember that the deadline for registering high-risk devices with the MHRA is April 2021, while the deadlines for moderate and low risk devices are in August and December 2021 respectively, so businesses will need to start making these preliminary steps immediately. Reviewing product portfolios and the compliance effort required for each product classification is a great starting point. Reaching out to strategic partners, notably an Approved Body and UKRP, should be the next step. It is important that manufacturers do not omit additional administrative tasks and data protection considerations from their planning and resource allocation. Finally, businesses should allow time to have their documentation updated and reviewed internally, and account for possible external delays once submitted.
It is highly likely that the regulatory landscape will further develop during the transition period. Brexit has provided the UK with a valuable opportunity to address concerns relating to medical device safety, such as those highlighted in the Cumberlege review.3
In fact, the UK is
already planning to appoint a Patient Safety Commissioner (PSC) as recommended by the review. Though developments such as these may initially add to manufacturers’ compliance burden, those that stay abreast of changes are likely to gain a competitive advantage in the long-term.
CSJ
References 1
https://www.gov.uk/government/collections/new- guidance-and-information-for-industry-from-the- mhra
2
https://www.gov.uk/government/collections/new- guidance-and-information-for-industry-from-the- mhra#clinical-trials
3
https://www.immdsreview.org.uk
About the author
Ed Ball is a senior associate at RQM+. He previously worked as a medical device specialist at the UK Medicines and Healthcare products Regulatory Agency (MHRA), and is currently an active member of the UK’s Technical Committees for Medical Device Quality Management and Risk Management standards. He is an accomplished medical device specialist and chartered engineer, who combines a technical understanding of medical devices with regulatory and quality management experience. Ed has 15+ years of practical experience with a wide breadth of medical devices, including but not limited to EU Class I – III, active devices, implantable
devices, diagnostic devices, measuring devices, devices used by lay people, and sterile devices.
Human Papillomavirus
Hepatitis B Virus
Human Immunodeficiency Virus
Protect your patients against the risk of infection from ultrasound probes.
Visit
www.nansonics.co.uk to find out more.
MAY 2021
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35
The trophon family includes the trophon EPR and trophon2 devices which share the same core technology of sonically-activated hydrogen peroxide.
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