Regulation of medical apps post 31 December

The MHRA has now published guidance on how the regulatory regime will look in 2021 and beyond. Clearly this will be subject potentially to significant change depending on trade negotiations currently underway with the EU. The really top level points are summarised as:

  • CE marking will continue to be used and recognised until 30 June 2023
  • Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
  • A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
  • From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA.

There are exceptions and grace periods so do please read the guidance. Most notable is that regulations will be different in Northern Ireland.

The MHRA will be consulting with industry over the next few months to flesh these out so members are encouraged to send me your comments, observations and concerns so that DHACA can represent them.

This will probably become a fixed item in our newsletters for some time now!

MDR survey

Of course if anything the new UK regulations will make life harder for exporters if there are conflicts. The MDR certainly continues to create concerns in the EU – Medtechdive reports that “almost half of medtech companies expect to spend 5% or more of their annual revenue on the EU Medical Device Regulation, results of a 101-company survey conducted by German software company Climedo Health suggest.” Reflecting the baffling complexity and the many recent changes of advice from the EC, “almost 70% of the surveyed companies spend most of their MDR-focused time trying to understand the new requirements.” For the future “three-quarters of respondents expect clinical evaluation and clinical studies to be the most expensive aspect of MDR compliance”.

Streamlining healthcare

Healthcare Digital has an interesting article looking at four apps that are streamlining healthcare. It includes the first significant app I am aware of from one of the large EHR vendors (Cerner) and a BT-endorsed staff communications app (Medic Creations). The one that intrigued me most though was the description of Doctorlink: after explaining that “What differentiates Doctorlink from its contemporaries is its online triage capability: a clinically-approved set of algorithms assess (based on questions) what someone’s health situation or condition might be, determine the acuity of the user’s problem and then recommend a course of action”, CEO Rupert Spiegelberg is quoted as saying “The advantage is that algorithms can be updated very quickly to identify people with specific symptoms, even if the disease is relatively new.” How he achieves this with the increasing regulation of medical devices described in the previous item is not explained.

Royal Society of Medicine webinars

The RSM Digital Health Section begins its Autumn webinar programme at 6pm on 3rd September with a talk by Rt Hon Stephen Dorrell, former health minister and Chair of the Parliamentary Health Committee with a talk on Perspectives on Health. The voucher DHACATEN64 will halve the price of entry. The webinar will be available for you to watch/watch again whenever you want in the next 30 days.

Details for subsequent talks that will be live at the same time on subsequent Thursdays can be found here, if you scroll to the bottom of the page. Vouchers for subsequent webinars are:

Improving communications – DHACATEN65
Digital tools and techniques in community settings – DHACATEN66
Automating processes with AI – DHACATEN67
Use of digital to release time for clinicians – DHACATEN68
Reflections on digital adoption – DHACATEN69

And finally…