Nothing could have been more illustrative for the medical device clinical trial environment in Europe than the storms Ciara and Dennis in February. With BREXIT as a kick off, the Coronavirus spreading around te globe, the MDR deadline less than 3 months away, and a new version of ISO 14155 coming out shortly, 2020 for sure guarantees a stormy year for any-one involved in medical device clinical trials
Per 31-January BREXIT finally is a fact, but what that actually means for clinical trials with sites in the UK is unclear to say the least. Without any say from UK’s end, EU regulations such as GDPR and MDR still apply, at least for 2020, but at the same time MHRA published an updated guidance regarding medical device clinical investigations indicating that a clinical investigation of a non-CE-marked medical device should at least be considered for certain circumstances, and notification to the MHRA will not be required if the medical device to be used is CE marked for the purpose under investigation. This comes across as less stringent than the MDR, that says that for class III devices and implantable devices safety and performance data, as a general rule, should be sourced from clinical investigations, and that PMCF studies that involve
“submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the Member States concerned”
So, in 2020, should we or should we not follow MHRA guidance when a UK site is involved in our clinical investigation?
As if we did not already have enough challenges in the EU medical device environment, there the CORONAVIRUS (or COVID-19) appeared, originating in China and spreading across the globe by now. By the end of last month, it started affecting device availability at the hospitals, but by now it also has a direct effect on our clinical study work due to travel restrictions and hospitals starting to keep out clinical trial monitors. Making remote monitoring in spite of its down sides, all of a sudden a much more attractive option. But are your EU clinical study sites ready for that, and how does that work again with the GDPR?
In the meantime, let’s not forget the MDR DEADLINE being right around the corner. With a substantially higher demand for qualitative clinical evidence, and, as a brief reminder, reasons for this include that:
- existing clinical evaluations need re-assessment following limitations on equivalence, state of the art, as well as clinical data that are considered suitable,
- several devices have been up-classified, and will require a more solid evidence base than before,
- planned activities for Postmarket Clinical Follow-up will require actual data collection, and are no longer a paper exercise, and
- clinical trial/ investigations supporting the regulatory files need to be conducted in compliance with the MDR and other Good Clinical Practices, such as ISO 14155.
So in short, due to a broader scope, better follow-up, as well as limitations on the use of existing clinical data, ‘the pressure is on’, especially for the clinical evaluations. The problem is, that when you do not have (access to) a lot of clinical data there is nothing to evaluate. I already see issues appearing with lower class devices that have been on the market for ages, but where complaint data and some publications from equivalent devices were considered insufficient under the MDD: Where does that leave us under the MDR?
So, and I cannot emphasize this enough, when in the fortunate situation that your device still has a valid CE mark, please make sure to pro-actively collect clinical data on safety and performance appropriate for your device and its intended purpose now.
The MDR mentions ISO 14155 as the GCP for medical devices, and the 2020 version will be coming out soon. An obvious attempt was made to align the two, but one should pay attention though, since their requirements with respect to clinical investigations are not 1:1. The MDR is, for example, more ‘lenient’ with respect to AE documentation, requiring recording of any AE
“identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation”,
whereas ISO 14155 requires all AEs to be documented. Furthermore, there are some nuances with respect to pre- and postmarket clinical studies. I will write a separate post on this topic soon, but when planning your clinical investigation make sure to know what bucket your medical device clinical trial belongs to, pre- or postmarket, interventional or observational, feasibility or regulatory, and what that means for the applicable rules.
In CONCLUSION, 2020 for sure is an exciting year for those in the medical device clinical trial environment and beyond, with a lot of question marks. Unsure what to do? Stay tuned and feel free reaching out for advice, ACS can help you finding the most cost-effective way for your device through this clinical evidence labyrinth.