Regulation, safety and sustainable development: three short important updates

Erik Vollebregt has just released a blog that should be read by anyone with a medical device or whose technology is likely to be classified as a medical device under the new Medical Devices Regulation (MDR – Regulation 2017/745/EU) which replaces the MDD in early 2020. It makes scary reading as to what will need doing to comply with the new regulations as approval under the MDD will no longer apply (no ‘grandfathering’). MedTech Europe has helpfully produced a flowchart describing the necessary steps. Advice from official sources given to this editor is that, as the MDR already applies in the EU, its continued application in the UK after Brexit is not in serious doubt, so UK companies should not delay.

The Digital Health & Care Alliance (disclosure; that this editor manages) and DigitalHealth.London are jointly running a digital health safety conference on 7th November. Key players in the UK are on the agenda (including the CQC, MHRA, HSIB, NHS Digital/England, Datix, Vitalpac etc.). This is a topic that requires the attention of all developers and providers of digital health, as new technology, being unfamiliar, is inherently risky. It is therefore really key for everyone involved to share experiences, understand the risks and carefully plan avoidance and mitigation.  The draft agenda and booking details are here (there is a small charge for lunch).

For those who have doubts about the benefits that mobile communications can bring at times, a read of the GSMA’s 2017 report on mobile’s contribution to the UN’s sustainable development goals will fill you full of optimism of what technology can do, for health and many other aspects of life. Beautifully presented and full of interesting facts: recommended! (If you’ve not enough time, the summary is here.) Hat tip to Prof Mike Short. 

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