The European Union approved legislation for a new approval system of high tech medical devices that mirror the approval process of the FDA. ARITHMOS gives a brief outline of the new proposed amendments and why Sponsors should consider implementing technology solutions in order to conduct more efficient and affordable clinical trials.

1. IMPLEMENTING TECHNOLOGY FOR NEW EU REQUIREMENTS ON MEDICAL
DEVICES
The European Union approved legislation for a new approval system of high tech medical devices
that mirror the approval process of the FDA. ARITHMOS gives a brief outline of the new proposed
amendments and why Sponsors should consider implementing technology solutions in order to
conduct more efficient and affordable clinical trials.
The current medical device approval process in the EU is guided mostly by national law. A conformity
assessment is performed by a notified body and the device obtains a CE marking meaning it can be
sold in the European Economic Area.
The new legislation would eliminate the equivalence principle commonly used for market approval
and require more sophisticated clinical trials. This means trial costs are going to increase and there
will be a need to collect additional clinical data to demonstrate the efficacy and safety of a medical
device. In an effort to guarantee patient safety, the EU is proposing more follow up during post-
market including more post-market studies. Companies will need to prepare data in a traceable and
readily available way.
How can Sponsors use technology to counter these changes?
One characteristic of medical device trials is that there is a lot of variance and therefore protocol
and study design are crucial. Device studies have many factors to consider such as small populations,
site differences and unique study endpoints. Incorporating EDC solutions into medical device trials
can be very beneficial. The availability of integrated data can enhance the overall development
process through greater efficiency and effective decision-making.
Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with
immediate feedback from patients. Data can be transferred in real time during the study and query
management is accelerated.
More Accessible Trial Information: An EDC solution can organize multi-language, global study data
into a single database. This is especially beneficial to statisticians who need up-to-date study
metrics, especially if they are applying an adaptive trial design method to the trial.

2. Higher Data Quality: EDC improves the quality of data through automated edit and discrepancy
checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.
ARITHMOS has a variety of EDC solutions to fit any study budget or requirements including
smaller medical device studies which require a reliable, yet cost-effective solution. Contact us to
discuss your EDC options.
Sponsors should also consider pharmacovigilance applications for the
analysis of safety data. ARITHMOS offers two customized reporting
solutions to automate signal detection and make safety data available
in real-time.
In addition to medical device legislation changes, Sponsors should also
be aware of changing pharmacovigilance legislation in the EU. The Good
Vigilance Practice (GVP) regulations went into effect in 2012, and more recently, the EMA has
released guidelines for complying with ICH E2B (R3).