18 Nov UK Responsible Person: Keeping up with Changes and Developments
For international medical device manufacturers looking to sell their products in the UK, the last 12 months have seen the introduction of multiple regulatory guidelines and timelines.
This includes ensuring all medical devices are registered with the Medical and Healthcare products Regulatory Agency (MHRA), with the final deadline for Class I devices rapidly approaching at the end of December.
Companies need to be actively preparing their medical devices for UKCA certification if they wish to place their devices on the Great Britain market after June 30, 2023. After this deadline CE certification will not be recognised.
These changes have introduced new challenges for manufacturers, both in keeping abreast of the new regulations and making sure submissions are made in a timely manner allowing for delays and potential bottlenecks, especially given the number of manufacturers approaching a very minimal number of approved notified bodies for certification.
As a designated UK Responsible Person (UKRP), our dedicated team have been working with clients to register their devices with the MHRA and legally place devices on the Great Britain market.
Ortho Consulting Group Product Manager Andrew Sangster is encouraging manufacturers who have not yet appointed a UKRP to act quickly to avoid potential issues in a regulatory landscape that has changed significantly.
“Since the previous MHRA deadline for Class II devices in September, we’ve seen response times from the MHRA lengthen and we believe that time is only going to get longer as more companies submit their devices,” said Andrew.
“If you are unfamiliar with them, the UK Medical Devices Regulations (UK MDR) can appear ambiguous and difficult to navigate.
“Class I registrations have been surprisingly time consuming as even though the products are lower risk and often less complex, the number and variance of Class I devices have led to more work than some registrations of higher risk devices.”
Complying with the new regulations and ensuring your full product portfolio can be placed on the Great Britain market can be an additional administrative burden, increasing workloads for staff unfamiliar with the legislation.
As a UKRP our team undertake responsibility for a number of tasks, which include providing the MHRA with all the information and documentation necessary to demonstrate the conformity of a device, forwarding requests made by the MHRA for samples to the manufacturer to ensure that the MHRA has said samples or has been given access to the device, and cooperating with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
“There is a lack of understanding about registration, and the difference between this and UKCA marking,” said Andrew.
“There is a lack of understanding about the difference between MHRA device registration requirements, the UKCA mark and the difference between the MDR in the UK and EU. It is completely understandable given the amount of regulatory nomenclature overlapping between these differing entities that manufactures can become confused and seek clear guidance or support.
“One question we often get asked is whether devices can be placed on the Great Britain market after the MHRA device registration deadline has passed without registration being completed/confirmed, and the answer is no. Devices can be registered with the MHRA any time after the deadlines, but can only be placed on the market and sold, once the device has been successfully registered on the MHRA portal.
“We are encouraging clients to address this with some urgency, to avoid a potential drop off in UK sales.”
For more information on how we can help your business, please get in touch with Andrew Sangster via andrewsangster@orthocg.com.