The medical device regulatory environment in Europe is moving, but not always as timely and as clear as one would wish, certainly not from clinical perspective. The
MDR/ IVDR Rolling plan
has been updated and mentions clinicals a few times, and I find the part on Eudamed stating that
“It is estimated that modules for clinical investigation and market surveillance might be only partly or not at all available at the time of application of the two Regulations (due to workability issues) but few months after.”
a little disturbing, especially as that will not only affect new clinical investigations, but also the ongoing studies: Among other things the MDR states that clinical trials that have started under the MDD prior to 26 May 2020 may continue, but also that reporting of serious adverse events and device deficiencies shall be done according the MDR. Meaning that from 26 May on these events need to be reported via Eudamed per Article 73 (e). So, althought progress has been made drafting the functional specs for Eudamed, I am not sure where this will lead us.
More MDCG guidance documents have been published and of particular interest from clinical perspective is the one on the clinical evaluation consultation procedure, with an (not legally binding) interpretation of the 3 criteria exempting devices from the clinical evaluation procedure with expert panels, and especially the one regarding
“new devices designed by modifying a device already marketed by the same manufacturer for the same intended purpose…”.
The interpretation is that “a device already marketed” cannot be intended to refer to a device already marketed uniquely under the new Regulation, and so, as Erik Vollebregt put it
“scrutiny is only for devices that are new at the time of the conformity assessment application for the MDR”,
which will be of great help trying to get some control over the workload of the expert panels.
And last there is the never ending story of the
Althought May is fighting it untill the bitter end, a no deal Brexit seems closer than ever, and the potential impact for those using or dealing with medical devices, and for UK patients requiring imaging and radiotherapy can be substantial.
Since UK Notified Bodies and competent authorities will no longer be recognized by the EU, medical devices and in-vitro diagnostics no longer can be brought to the EU market via UK: devices which enter the EU via or from the UK will be handled as import from a third country with all related consequences.
Patients with cancer in the UK are expected to face substantial challenges accessing the best care, as among other unfavorable developments, hospitals no longer carring out their own PET-CT services, deliveries of radiopharmaceuticals delayed and certain patients prioritised over others.
the medical device environment in Europe is changing, with several moving parts and many uncertainties for manufacturers, users, and patients. We should keep in mind, thought, that most changes have been initiated for a better protection of patient safety.
Feel free reaching out to discuss any of the above or other aspects of the medical device clinical pathway in Europe.