Weekly Rundown - 26.02.23

I had to skip through the week 7 as other commitments caught up with me and left me with no time to sit down and reflect on the latest weeks developments. It felt as if I failed my new years resolution, but I am back on it!

We’ve seen an increase in activity over the last two weeks, evident with almost every channel that we track. The web traffic, enquiries, calls – all up when compared to January. It seems that businesses are letting go of their budgets now that we are entering the last month of Q1. We started the year with some uncertainty related to the EU MDR extension, but now that European Parliament has voted to extend MDR transition period and most medical device manufacturers had taken the time to read the small print, I am sure that medical device testing sector as a whole will see an increase in their service demand. Briefly on the extension - the new timeline depends on your device risk class and extension is subject to certain condition. Only devices that are safe and for which the manufacturers have taken certain steps to transition will benefit from the additional time.

• (a)31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;
• (b)31 December 2028, for class IIb devices other than those covered by point (a), for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function.

In a brief publication, MHRA said that they are working to consider carefully what the implications of these revisions are for acceptance of CE marked medical devices on the Great Britain market. On 25 October 2022, MHRA announced that the introduction of the future UK Medical Device Regulation will be delayed by twelve months. The intended date for introduction of the new and standalone regulation was set for July 2024.

Last week I had an opportunity to join Monir El Azzouzi at his podcast where we have discussed what does it mean to transition from Class I to Class Ir medical device. We’ve covered a lot of ground during our chat, but one thing is clear – any regulatory change need to be clearly communicated as manufacturers are ending up making mistakes in their interpretation with a cost of rejected technical file. The podcast will be out on the 28th of Feb – have a listen.

Earlier in the month the Department for Business, Energy and Industrial Strategy was split into three, creating the Department for Science, Innovation and Technology, the Department for Energy Security and Net Zero, and the Department for Business and Trade. I am particularly interested in Department for Science, Innovation and Technology as this department will be responsible for driving innovation and R&D funding. It is clear that the new department will inherit old issues, such as R&D tax system and access to EU research programmes, but everyone are waiting to learn more about its role and goals. Among many set priorities the newly split department will focus on R&D investment and delivery of key legislative and regulatory reforms. The backdrop, however, last week was quite bleak with reports of ￡1.6 Billion of R&D funding that has been returned to the Treasury. Amongst many expert reactions to the reports – it is clear that most feel let down by the Government promise for further investment with some saying that this will risks long-lasting damage to UK ambitions for economic growth. My team and I certainly know what it feels like to miss out on a funding opportunity – my colleague Eleanor Barnes released a blogpost sharing our experience. The report is deeply worrying as reliance on funding is greater than ever before, with UK potential at becoming worlds science superpower being at risk.