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
One of the biggest, hidden, changes is the importance of the clinical evaluation report. While the MEDDEV guidance [5] has been around for some time, the rigour of assessment of the report, and the importance placed upon it for the overall granting of a CE mark has increased under the new MDR. This is particularly true for the presentation of evidence of an assessment of a device’s performance. Simply stating “these types of devices have been in use for years” is no longer going to pass muster (and especially so for implants). This means that all devices will require some form of testing and analysis in laboratories, like mine at Keele, before technical documentation is complete and can be reviewed.
Equally, the new guidelines expect a comprehensive review of learned papers. I suggest that most medical device companies will not have the skills to produce a suitable review, and many would not know where to start. I very much doubt they know how to conduct a systematic review. Again, I foresee a lot of work for researchers like me, for which such a review is a weekly task, producing said documents.
It is clear that new devices in the higher classifications will have a lot more time, effort, and cash allocated to enable this requirement to be met. This may well become a barrier to many new products; especially for anything that may be considered as an implant. It will certainly have implications for new generations of “healthcare apps” in development.
Bar codes/UDI
This is probably the biggest change that everyone will notice. The USA has had unique identifiers in place for some time: called GUDIs. The EU UDI is, effectively, the same – but the FDA registration process/database is more mature and established. All products will require a unique identification number. This number is totally unique and contains a primary indicator (PI) that only a few providers, such as GS1, can allocate them. They are exactly the same as you find on the back of a product you would buy in a shop. This PI, in combination with lot numbers, date of manufacture etc., make up a UDI. This PI is different for a single item, a box of five, or a case of 10 x 5. The question is, does this PI replace a part number/catalogue number as we know it? It seems nonsense to have both; but it also seems a nightmare to change.
An example of a UDI bar code is illustrated in Figure 1. It is nearly 100mm in length, and contains over 80 characters. The item marked (01) is the PI. The same information can be provided as a QR code (Figure 2), but do healthcare providers have the capability to read a QR code? Do they have the capability to decompose either the bar code or the QR code?
Many implants, for example, will be required to have the UDI permanently marked on it. Patients, having an implant, will be given an implant passport with the UDI marked upon it. The main reason being that traceability is maintained, even many years after the implant was fitted.
Class I devices
If you thought Class I devices were immune, sorry they are not. Those of you who use Rule 6 to classify a reusable surgical device as Class I will be disappointed. All reusable surgical instruments are now in the same category as those with a measuring function, or those supplied sterile: they will have to be submitted to a Notified Body for CE marking as Class I Reusable (Class IR). It also means that, in the future, they will have to carry a CE mark and associated number to be compliant [1].
This has major implications for manufacturers, but also for purchasers. For example some instrumentation sets (that are currently Class I) will suddenly become a mix of Class I and Class I reusable (IR) overnight. Does this make the whole set Class IR as per convention? Or will the instrument set be supplied as a class I set with the Class IR item supplied separately? This could become a tracking nightmare. It will definitely mean that all existing reusable surgical instruments may have to undertake new sterilisation validations to prove they can be cleaned and sterilised.
Summary
I only have space to comment on a few of the changes, of which there are many. It should be clear, therefore, that the new MDR will have an effect on manufacturers, purchasing departments and clinical staff alike. There is a need for an education and training program for end users and purchasers to ensure they are buying and tracking new devices correctly. Equally, there is a need for all medical devices manufacturers to implement compliance, if not already doing so.
Everyone is going to be on a steep MDR learning curve. Maybe there is a need for an ombudsmen service (to act as a referee between a medical devices company and their Notified Body) in the, wholly predictable, event of a dispute between the two with regards to an interpretation of the MDR.
References:
- TUV , (2019), FAQs Medical Device Regulations.
- NHS supply chain, (2019), Webinar: MDR compliance
- EU, (2017), 2017/745 [downloadable from https://bit.ly/2NFjj2e]
- ISO (2016), ISO13485
- EU (2016) MEDDEV 2.7/1 rev4 (downloadable from europa.eu)
Professor Peter J Ogrodnik is course director for the MSc in Medical Engineering Design at Keele University. The opinions presented do not necessarily reflect those of the university, its staff or its students.
