The Medicines and Healthcare Products Regulatory Agency (MHRA) has published important plans regarding the future regulation of medical devices in the UK. These plans are intended to promote innovation and patient safety.
Many assistive technologies fall under the umbrella of medical devices. By definition, medical devices include any device, software, or equipment intended for humans with the specific medical purpose of diagnosing, treating, monitoring, or relieving diseases, disabilities, or injuries.
This includes devices used by allied health professionals, such asprostheses and mobility scooters.
Plans also include IVDs (in vitro diagnostic medical devices). These medical devices are intended to be used in vitro to examine specimens derived directly from the body. They can provide information about a physiological state or pathological condition, monitor therapeutic measures, provide information about congenital abnormalities, and determine safety and compatibility with donors.
We provided a summary of what the assistive tech sector should know about MHRA's plans for medical device regulation in the UK. It also included key industry responses from the British Healthcare Trades Association and the Association of British HealthTech Industries.
Background Information
Following the UK's departure from the European Union, the UK has seen changes in its medical device regulation. MHRA believes it has a unique opportunity "improve" UK medical device regulation, with the ultimate goal of improving people's health.
The UKCA marking will be applied to medical devices that have been certified as meeting the UK's regulations.
Recent Developments in UK Medical Device Regulation.
MHRA now has its response to its consultation about the new regulationsfor medical devices in the UK.
This package of reforms will apply to medical devices like hearing aidsand new technologies such as smartphone apps and artificial intelligence (AI).
These are the new measures:
· To keep patients safe, MHRA should be strengthened.
· To respond to public needs, we must expand the regulation's scope andreach.
· Health disparities are addressed and remediated to reduce medical device development and use inequities. This will ensure that they work as intended for diverse populations.
· Make the UK a centre for innovation by ensuring the new regulatoryframework encourages responsible innovations.
Construction of the UKCA mark to replace the CE mark andensure that the mark enjoys a strong reputation globally
Plan for transition
The new regulatory regime will still be in effect as of 1 July 2023.However, the government acknowledged serious concerns raised by BHTA regarding continuity of supply, lack of conformity assessment body, hard-pressed MHRA
resources, and the need to get input from the industry about how the regime should operate.
The UK's Medical Devices Regulatory Agency (MHRA) has created atransitional period to ensure the continuous supply of medical devices. This will allow sufficient industry time to adjust to the new regulatory regime.
This transitional period was welcomed by the BHTA since there weregrowing concerns from trade associations and the industry about July 2023.
William Lee, Head of Policy and Compliance, British Healthcare TradesAssociation, explained the transitional period in his consultation reply. "General medical devices and in-vitro medical diagnostic devices(IVDs) that have been CE marked under EU MDR (or EU IVDR) may be continued to be sold on the GB marketplace until the certificate expires, or until five years after the new regulations go into effect (i.e. 01-Jul 28), whichever comes first, to review this provision at expiration. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect.
"General medical devices and IVDs CE marked under EU MDD or EUAIMDD, or EU IVDD can continue to be placed on GB markets until the certificate expires or for three years (general devices) or five (IVDs) after new regulations go into effect (i.e. 01-Jul-28, whichever comes first, and to review this provision at the expiration of the five years."
Two caveats for both CE-marked medical devices fall under these arrangements.
These provisions will not apply to devices that have undergonesignificant design changes or are intended for a different purpose.
All products that benefit from the transitional arrangements must complywith post-market requirements.
All products that benefit from the transitional arrangements must comply with post-market requirements. to the UKCA standard before the new regime takes full effect, these products may be placed on the GB market until either the certificate expires or for three years after the new regulations take effect (general medical devices) or five years (IVDs).
I3CGLOBAL also welcomes the transitional period for UK medical device sector. This is in line with the BHTA's assertion that it will allow sufficient industry time to adapt to these new changes. The association looks forward to furthering engagement via planned focus groups in the coming months. These are meant to help develop guidelines to follow UKCA regulations.
More Useful Resources -
- FDA is preparing guidance for pre-launch policy on drug imports
- Does the CE mark been lost to new medical device manufacturers?
- 7 Product Safety Certificates: What they Mean and Why They Are Important
- FDA establishes a process for foreign formula manufacturers to sell their products in the USA permanently
