You probably did read it by now, but just in case, herewith a few items that stood out for me while reading the EU Q&A for clinical investigations under the MDR ((MDCG 2021-6) published jst before the May 26th deadline.
The guidance contains very helpful oversight on definitions on medical device performance, clinical performance, and clinical benefit, as well as an overview on the regulatory pathway for clinical investigations (or studies) under the MDR.
Given rumors were that non-interventional Post-market Clinical Follow-up studies do not fall under the MDR, I am happy seeing that per this overview these studies generally speaking are considered falling in the category ‘Other clinical Investigations’ (Article 82). Meaning that in principle such studies should comply with some provisions of Article 62 (legal rep, scientific & ethical review, informed consent, etc), as well as the applicable local regulations, unless you have a PMCF activity that does not meet the definition of clinical investigation, such as generic surveys and some specific types of data collection. Besides the questionable scientific value of with such tools, however, one needs to be very careful guarding data-privacy (health-care data are particularly sensitive under the GDPR), but then these activities may be justifiable for some of the lower (risk) class devices.
Mind you, you still need to check local regulations, and should be careful claiming to follow GCPs, since ISO 14155: 2020 has a different definition of clinical investigation, and states that if
”… requirements are less strict than the requirements of this document, the sponsor shall apply the requirements of this document to the greatest extent possible, irrespective of any lesser requirements…”.
Food for thought
With respect to MDR applicability,I am not sure what the guidance means to tell us with
“For clinical investigations of class I, or non-invasive class IIa or class IIb devices, it is necessary to check national provisions”?
In case of clinical studies we always need to check national requirements since local regulations tend to differ across the EU member states, and, again, conform ISO 14155 the sponsor shall apply the most strict requirements.
Or is the guidance meant to say that ‘For clinical investigations not performed pursuant to any of the purposes listed in Article 62(1), it is necessary to check national provisions’? Food for thought I think.
As said above, the definitions (and applicability) for clinical investigations can be crucial, and it is good seeing attention for the definitions of Performance (ability to achieve the intended purpose), and especially Clinical Performance (leading to a clinical benefit) and Clinical Benefit:
“The positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient relevant clinical outcome(s)”.
Specifically patient relevant outcome(s) can be challenging for some devices (also refer to my previous blog on clinical evidence dilemma’s) since clinical evidence on patient benefit often is indirect, and patient outcomes such as a mortality, morbidity, and Quality of Life can be challenging due to endpoints depending on the underlying disease, and can require long-term patient follow-up.
In line with the adoption of
back in April, the MDCG 2021-6 refers to the 2020 version of the GCP for medical device studies (instead of the 2011 version), for the different product development stages and related clinical investigations, but also for the content of your clinical trial report in ANNEX D, so it is key to familiarize yourselves with it’s content.
Last but not least, a few notes regarding
Ongoing medical device clinical trials
that started before MDR application: such studies can continue with the note that all (S)AE’s and device deficiencies that might have led to a serious adverse event “if appropriate action had not been taken” need recording, and that all SAE’s and device deficiencies occurring after 26th May 2021 need reporting according Article 80 of the MDR. In light of the fact that EUDAMED is not ready yet, reporting to National Competent Authorities can be done as before, but as a sponsor you are expected to review and update your protocols and procedures as needed. MDCG 2020-10/1 is also referenced for further guidance in this respect.
In conclusion, I think it is fair to say that although late the Q&A on medical device clinical trials is a helpful guidance with some room for interpretation and/ or debate.
Feel free reaching out should you be interested to discuss the above or any other aspects of the clinical evidence collection proces for medical devices.