As a contract research organization (CRO), CERES addresses your goals and requirements on medical devices, both before and after demonstrating CE conformity. We offer the complete management of clinical trials and evaluations, as well as just the supporting components you are looking for. Therefore, while gaining or maintaining CE mark, we always take into account your needs as well as the regulatory requirements.
In 2005, Dr. Stephan Joeken founded CERES, foreseeing increasing requirements for clinical trials on medical devices in Europe.
Since 2007, clinical trials on medical devices have been required: The European Directive for Medical Devices 2007/47/EC was written to amend the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Device Directive 90/385/EEC (AIMD).
In 2008, we introduced our exclusive online data-capturing system, “aTRIAL”. aTRIAL facilitates qualified electronic capture of clinical trial data, and supports Case Report Form (CRF) handling, monitoring, and reporting. aTRIAL is an efficient EDC system, and significantly reduces the time necessary for, and cost of, data collection. Our customers can choose between collecting clinical data on paper, or via an EDC system.
In 2010, the “Guidelines on Medical Devices: Clinical Evaluation, A Guide for Manufacturers and Notified Bodies,” MEDDEV 2.7/1 rev. 3, by the European Commission on Cosmetics and Medical Devices, took effect, amending Directive 2007/47/EC. These guidelines described a required periodic clinical evaluation for medical devices by either literature review demonstrating substantial equivalence to CE-approved medical devices for which adequate clinical-trial data already exist, or conducting clinical trials.
Our next generation data-capturing system, “aTRIAL” was released. aTRIAL V2 facilitates qualified electronic capture of clinical trial data, and supports handling of individual Case Report Forms (CRFs), monitoring, and reporting.
We support the national strategy process Innovations in medical technology “Innovationen in der Medizintechnik” for medical technology and actively showed the opportunities of a proactive PMCF. The process was organized by the Federal Ministry of Economics in cooperation with the Federal Ministry of Research and Federal Ministry of Health.
In June 2016, the “Guidelines on Medical Devices: Clinical Evaluation, A Guide for Manufacturers and Notified Bodies,” MEDDEV 2.7/1 rev. 4 , by the European Commission on Cosmetics and Medical Devices, took effect. Other relevant regulatory changes have addressed software, disposables and their re-use, implantable devices, manufacturer’s specifications, and instructions for use.
On April 5, 2017, the EU Parliament passed the new Medical Device Regulation (MDR). With a few exceptions, the regulation on medical devices is applicable from 26 May 2021, i.e. after the extended transition period.
Manufacturers are affected by the demanding new clinical requirements and the extensive documentation and reporting requirements. Regulatory compliance forced some medical device manufacturers to take drastic steps. Thus, the transition results in a significiantly changed medical technology industry.
Many companies addressed the challenges and realized that the changes required an enterprise-wide approach. Also, some companies recognized that MDR is not only a compliance challenge, but also an opportunity.
We have moved to our new premises. On the one hand, we did justice to our steady growth. In particular, however, it was foreseeable that the upcoming MDR-related changes would require further resources.
The MDR comes into force on May 26th. As your CRO for medical devices, CERES implements its services according to the latest regulations so that the needs of manufacturers can be efficiently supported during the changes and in MDR-compliant projects.
At CERES, our comprehensive understanding of these past and potential regulatory changes, and our proactive project management style have lead to our success. Especially for long-term clinical trials, early consideration of regulatory changes is important.
CERES has performed clinical studies in several European nations, and has achieved CE approval for numerous medical devices via literature-based clinical evaluations. As we proceed together into the future, both our employees and management thank all of our customers for their confidence in our ability to meet their ongoing needs.
In the future, we hope to share our success with you.