This issue’s comment by Peter Ogrodnik looks ahead at how the medical devices regulations landscape is set to change in 2020
Brexit has, recently, dominated the news. But it has hidden another, imminent change to the medical devices landscape. In Spring 2020 the new Medical Devices Regulations (MDR), EU 2017/74, and In-Vitro Diagnostic Regulations (IVDR), EU 2017/746, come into force. In essence this means that any medical device placed on the market after 26 May 2020 need to meet these new regulations. Existing devices having a CE mark under the old Medical Devices Directive (93/42/EEC) could have a grace period [1] up to 26 May 2024 to obtain a formal MDR certificate, so long as the devices can be shown to meet the requirements of the new MDR. As recently as last month the NHS supply chain [2] held a webinar in which they stipulated that all suppliers of medical devices to the NHS must meet the new MDR by 26 May 2020. This advice ignores the outcome of the UK leaving the auspices of the MDR, by default, on Brexit day; and despite the grace period described earlier.
The MDR document is 177 pages in length [3]. With the IVDR this is a combined 336 pages to read and condense. I will try and summarise a few of the main changes that may impact on orthopaedics.
End-user input
While there has been an unwritten protocol that end-users should be included in the design process this has, often, been limited to talking to a lead clinician and having the odd focus group when a prototype is produced. This is no longer the case. All new products and devices will need to demonstrate end-user input in the design stages. Most successful product developers do this as a matter of course. However, there are many examples of devices, that all of you can think of, where your first thought is “why did you do that?” The aim of this amendment is to improve quality. How clinical staff will view the growth in requests for “advice” is yet to be understood.
Post-market surveillance
A combination of a new ISO13485 [4] and the new MDR means that post-market surveillance (PMS) is, now, more rigorous. Once again, in the past one could get away with a simple analysis of complaints and current literature across the whole product range. Now PMS has to be a part of the new technical documentation for every product; and it has to be pro-active. This means a medical devices company should “seek” feedback post sale; end-users, therefore, can expect to receive many more requests for feedback. Again the aim is to drive up quality, and to catch potential issues before they escalate.
In practice, however, every auditor sees a company as an individual case. They do not see that a particular end user may have more than 100 suppliers. Hence end-users could spend their whole working life responding to questionnaires. Especially as I imagine this will be a vehicle to prove “end user input”.
Clinical evaluation