In 2012, the European Commission proposed a new medical device framework to ensure all medical devices are safe. This proposal came after several reports of devices already on the market led to serious injury or even death.
In April 2017, the Commission officially welcomed the adoption of two Regulations – 2017/745 for medical devices and 2017/746 for in vitro diagnostic medical devices – to improve quality, safety and reliability of medical devices.
Controls will be tightened on clinical trials as well as the bodies that can approve the marketing of medical devices.
One of the biggest changes is the increase in transparency of information for consumers. A Unique Device Identifier will be mandatory for every product so that it can be found in the new European database of medical devices (EUDAMED).
Advice for Sponsors conducting medical device trials under the new Regulations:
1. Consider a full service approach with a CRO that has considerable experience in medical device studies for the European market
2. Consult expert biostatisticians in order to guarantee successful protocol and study design.
3. Consult a regulatory expert to ensure compliance with the new regulations. If you are outside the EU and looking to conduct medical device studies for EU approval, consult regulatory experts in this area. There are also particular advantages for Small Medium Enterprises (SMEs).
4. Incorporate the appropriate EDC technology solution to ensure data traceability. Search for providers that can offer a range of solutions to meet specific study and budget requirements such as independent study build and management and quick training periods.
5. Consider a statistical programming team that can comply with database requirements such as data anonymization as well as CDISC data standards.
6. Consider a centralized biometrics approach – keeping all clinical data with one specialized vendor – to increase efficiencies and reduce costs.
7. Incorporate a centralized monitoring solution in order to monitor the quality of sites and site data remotely and more accurately. This type of solution can include data visualization and analytics, risk management metrics and a centralized statistical intelligence approach.
8. Ask your biostatistician about adaptive trial design and Bayesian models to factor in several variability elements.
9. The Regulation will look closely at post-market surveillance and require more data and analysis post-market. Enlist a provider that has experience in post-market medical device studies and can support on the regulatory side.
10. Consider Scientific Advice from the EMA. Are you an SME? You could qualify for SME status with the EMA resulting in 90% reduction on scientific advice and other EMA services.