MHRA Scientific Advice: Medicines vs. Medical Devices

We have a long history of organising and running MHRA scientific advice meetings (SAMs) for clients both within and outside the United Kingdom. In recent years, many of these meetings have focused on post-Brexit requirements to develop appropriate strategies in line with the changing regulatory landscape since 1 January 2021. Five years on, we are sharing details of the refreshed MHRA scientific advice process for medical devices.

For completeness, we have compared this new guidance with that used for medicines, and included the latest key performance indicators for MHRA scientific advice as well as the associated fees. In our experience, reclassification SAMs (prescription to non-prescription status) do not sit within any backlog and meetings are scheduled promptly.

Comparison of Medicine to Medical Device SAM Process

	Medicines	Medical Devices
Duration	90 minutes	60 minutes
Cost	£986 simple complexity; £17,516 high complexity. Paid at least 15 working days prior to the meeting.	£987. Paid at least 15 working days prior to the meeting.
Scope of meeting	Short presentation up to 10 minutes then discussion of questions and issues.	Short presentation up to 10 minutes then discussion of questions and issues.
Process	Complete a request form with a complete list of questions (applications will not be processed without these).	Complete a request form with background information and list of questions.
Timing of meeting	A mutually agreed date will be set once the MHRA receives the list of questions (current KPI: within 15 working days).*	MHRA will propose a meeting date and time within 15 days.
Documentation to be provided	Briefing book and any slide deck at least 15 days before the meeting.	Presentation slides 14 days before the date.
Responsibility for meeting minutes	Applicant	Applicant
Meeting minutes sent	15 days post meeting.	15 days post meeting.
Final meeting notes received	30 days post meeting (current KPI for medicines not currently being met).**	30 days post meeting.

* Current KPI suggests date will be agreed within 15 days.
** Current KPI from the agency suggests this timeline for medicines is currently not met.

KPI Update on Scientific Advice

We note that for scientific advice the latest performance data shows:

• The average time for providing written advice ranged from 20 to 38 working days (established medicines to clinical trials categories).
• The average time for offering a meeting date ranged from 3 to 9 working days (clinical trials to biologicals categories).
• 90% of requests for scientific advice were offered a meeting within 10 working days of submission.
• 63% of requests received written advice within 30 working days of submission.

In our experience, the timelines for receiving feedback are shortening, although we have waited longer than 12 weeks for feedback in the latter half of 2025.

As with all advice, the agency highlights several caveats. The MHRA's advice is based on the questions and documents submitted and cannot take account of future changes in scientific knowledge or regulatory requirements. Scientific advice from the MHRA is not legally binding for future applications involving the discussed product and should not be viewed as an indication of an agreed future position. Alongside the SAM process there is also the opportunity for fee reductions for Small and Medium Enterprises – particularly attractive for companies beginning a development pathway for a new product or concept – and we can assist with this.

Overall, the medical device process appears to mirror the established and well-tested medicines pathway, although only time will show how experience and performance compare.

How regenold UK Can Help

We firmly believe the scientific advice process is a valuable chance to shape your product strategy early and avoid costly missteps later. Get in touch with our team so we can support you through the journey.

References: Medicines scientific advice  ·  Medical device scientific advice