The updated overview from December suggests we theoretically will get some more clinical guidance the next few days, but I would not bet on it. The 2-year delay in EUDAMED implementation, indeed, seems a valid argument to prioritize some clinical evidence guidances over others serving as input for EUDAMED. However, being in the process of preparing clinical evaluations, as well as pre- and postmarket clinical investigation documents, it would be very helpful to have some of the planned guidances available now, and not 2 minutes to midnight.
Guidance documents issued sofar with interesting clinical aspects include the following:
Guide on the summary of safety and clinical performance (August, MDCG 2019-9), providing instructions regarding the SSCP as applicable for implantables and Class III medical devices. Besides some general elements, the most noteworthy I find is that the summary
- in line with the clinical evaluation, should include favorable and unfavorable data,
- in addition to English should be available in the Member State languages where the device is intended to be sold,
- should be available as a HCP version and a patient version for implantables where patients will be given an implant card, and class III devices intended to be used directly by the patients, and
- should be referenced in the IFU with its location in EUDAMED (interesting given the 2-year delay),
Guidance regarding the ‘person responsible for regulatory compliance’ (June, MDCG 2019-7), mentioning that all manufacturers are required to have at least one person available within their organization responsible for regulatory compliance, and while referencing the MDR for guidance on what the PRRC is expected to do in case of EU clinical investigations and performance studies, it emphasize also that the manufacturer shall ensure that a signed statement by the
“… person responsible for the manufacture of the investigational device [for performance study] that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation …”
Note that per MDR (and ISO 14155 as well, refer to my previous blog post) ‘investigational device’ means any device being assessed for safety and/or performance in a clinical investigation, so this includes devices subject to PostMarket Clinical Follow-up studies.
Guidance on qualification and classification of software (October, MDCG 2019-11), providing direction for software falling within the scope of the MDR, and emphasizing that manufacturers of Medical Device Software (MDSW) must ensure
“that any claims, relating to the intended medical purpose of their MDSW are supported by clinical evidence”,
and that for all MDSW safety and performance is ensured
“… throughout the lifecycle of the software, through a continuous process of clinical and/or performance evaluation and risk management”,
and last, as a kind of Christmas present:
Guidance notes for manufacturers of class I medical devices (December, MDCG 2019-15), providing direction to Class I medical device manufacturers; among other things, emphasizing once more that under the MDR
“All devices, regardless of risk classification, require a clinical evaluation as part of the technical documentation”,
with the note that
“… the level of clinical evidence will be appropriate in view of the characteristics of the device and its intended purpose”.
giving some room for the lower risk class of devices on the degree of clinical evidence needed, provided the manufacturer can justify this in light of device at hand. So not every device requires a Randomized Clinical Trial!
In conclusion, with the MDR deadline around the corner for all the applicable devices (all new medical devices, not upgraded class I devices, and class IIa, IIb, and III devices with significant changes) for clinical activities & documents, we still need to rely on our own interpretation of the applicable sections in the MDR in combination with existing guidance documents for the MDD and the AIMDD. Let’s keep out fingers crossed that for patient’s safety sake, all parties involved have a similar interpretation while working on the collection & evaluation of clinical evidence substantiating safety and performance of the concerning medical devices.
With the Best Wishes for 2020!