Clinical research for medical devices, since 2005

As a contract research organization (CRO), CERES can help you solve your problems and meet your goals, both before and after demonstrating CE conformity. We offer complete clinical trial management for medical devices, as well as just the help you need to succeed. We can fulfill the ongoing regulatory responsibilities necessary to gain and maintain your CE mark. We also perform market surveillance via Post-Market Clinical Follow-up (PMCF) studies. All of our services can be customized to fit your needs.

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 efficient, and significantly reduces the time necessary for, and cost of, data collection. Our customers choose between collecting clinical data on paper, or via aTRIAL.

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. Other relevant regulatory changes have addressed software, disposables and their re-use, implantable devices, manufacturer’s specifications, and instructions for use.

Proposed EU medical device regulations are currently under consideration. In September 2012, the European Commission published its “Proposal for a Regulation of the European Parliament and of the Council on medical devices”. Further, in October 2013, the European parliament discussed “347 amendments to the proposal.” CERES will observe ongoing changes and keeps its services up-to-date.

On April 5, 2017, the EU Parliament passed the new Medical Device Regulation (MDR). With a few exceptions, the regulation on medical devices will apply from 26 May 2021, i.e. after the extended transition period.

Smaller and medium-sized companies are potentially hit particularly hard by the demanding new clinical requirements and the extensive documentation and reporting requirements due to lower staffing and funding opportunities. Regulatory compliance can force some medical device manufacturers to take drastic steps.

The transition will result in a medical technology industry that is significantly different from today’s.

Many companies have started to address the challenges and realized that the changes require an enterprise-wide approach. These companies have recognized that MDR is not only a compliance challenge, but also an opportunity to add value to the business at this time.

CERES published an article in “Medical Device Developments”, November 2014, about the proposed regulations with relevance to medical device manufacturers. When and if the 2012 proposal as amended will be accepted, CERES is ready to help you to comply with this new regulation.

At CERES, our comprehensive understanding of these past and potential regulatory changes, and our proactive project management style have lead to our success. Esprecially 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.