EU Updates: MDCG Meeting on Device Shortages due to the May MDR Cutoff & New MDR/IVDR Industry Survey
April 26, 2024
New IMDRF Guidance: Labelling, Safety & Performance, Regulatory Review Reports and more
May 5, 2024Background
As reported previously by Casus here, the MHRA is in the process of testing their new International Recognition Framework.
This new mechanism would allow devices that do not have CE or UKCA Marking, to still access the market. For example, if a device “only” has marketing approval in the US (e.g., 510(k), de novo, PMA), then this can be leveraged to sell in the UK. If you’re familiar with the Australian TGA or Singapore HSA’s ‘abridged’ review systems, it is similar in concept to that.
MHRA’s Call to Action
As part of this, the MHRA is working directly with manufacturers on the practical application of the process.
Currently the MHRA is working with 4 multinationals, all of whom approached the MHRA. However, the MHRA:
“…would very much like to hear from smaller companies, particularly where their products might encompass software either as a medical device or as an IVD, who would be interested in accessing the UK market but who have targeted another market as their first launch country.”
The deadline is next week, so you need to act fast if you want to participate. More information is available: HERE
Take Note
- This will not result in your device being granted marketing authorization. Instead, it is to help the MHRA identify weak points, and develop the future process.
- Only 10 spots are available; at least 4 spots are already taken by multinationals.
- It is on a “first come, first serviced” basis.
- The device should not already have CE or UKCA Marking.
- The MHRA is particularly interested in involving a range of scenarios for better testing, including software as a medical device or IVD.
- The MHRA has given the US FDA as an example market; however, as far as we have seen, it has not published a list of eligible countries.
- A reasonable presumption is that it would include some of the IMDRF countries, e.g., Japan, Australia, Canada.
Deadline & Contact Details
If you would like to participate, please contact the MHRA no later than Thursday, May 2, 2024.
You can reach them at: info@mhra.gov.uk
The MHRA will publish their policy intent for international recognition in the coming weeks. Stay tuned.
