Dr. Ebeling & Assoc. GmbH
Comprehensive Advisory Services to Endorse Medical Devices for a Positive Benefit-Risk-Ratio

Throughout the healthcare industry, physicians, nurses, and other professionals rely on a slew of medical devices in order to deliver the best possible patient care. Health systems across the globe depend on original equipment manufacturers (OEMs) to develop the most effective and compliant medical devices that enhance a care giver’s ability to drive better health outcomes. However, owing to the recent developments in the global healthcare realm, many countries are now pushing for a sustainable regulatory framework for medical devices to ensure a high level of health and safety while supporting innovation. The member countries of the EU, especially, are in favour of a revised version of its 2017 Medical Device Regulation (MDR), which is scheduled to come into effect from May 26 2021. The regulatory framework is predicted to identify medical devices and improve its technological advances, along with the establishment of a European database on medical devices (EUDAMED), among other things. At this juncture, Dr. Leonardo Ebeling, a renowned authority in the pharmaceutical and healthcare space, believes that while MDR will motivate medical device OEMs to design and develop better products, they will also hinder an organisation’s current progress in its respective marketplace. “Many medical device manufacturers are still in the dark about the particulars of revised clinical documentation and vigilance requirements of the MDR,” adds Ebeling.

In order to help these medical device OEMs and other healthcare companies cope with these changes and transition with limited disruptions, Dr. Ebeling & Assoc. offers a wide assortment of vigilance services that are backed by its staffs’ expansive medical and scientific expertise. The company was founded by Dr. Ebeling with a clear motive in mind: improve documentation processes and product safety throughout the medical industry, while delivering prospective vigilance and quality management services that help clients reach their organisational goals. Dr. Ebeling & Assoc.’s area of expertise revolves around clinical evaluation plans and reports (CEP; CER), biocompatibility evaluation plans and reports (BEP; BER), alongside audits and gap analysis capabilities against stringent MDR requirements for the performance of substance and non-substance-based medical devices. “Gearing up to face the new guidelines, clients are in urgent need of new CERs and plans to remain compliant. We help them avoid unnecessary complications by offering comprehensive product safety and medical writing consultation services,” expresses Dr. Jasmin Lindner, medical science and affairs, vigilance and pharmacovigilance at Dr. Ebeling & Assoc. Additionally, Dr. Ebeling and his team carefully assess the CERs already prepared by a client with respect to its quality and completeness as far as compliance with the regulatory environment.

We also report incidents to the responsible authorities using the current manufacturer incident report (MIR) template, and prepare periodic safety update reports (PSURs)

Based on the existing scientific data, the company advises its clients on how to adapt and conduct studies that fill essential gaps in their CER, if applicable.

To this extent, Dr. Ebeling & Assoc. prepares post market surveillance (PMS) and post market clinical follow up (PMCF) plans for its clients in accordance with the MDR guidelines. The company leverages the vast experience of its noteworthy workforce to provide holistic advice on medical affairs and science regarding early and late-stage development and PMS for various products and devices as well. In fact, Dr. Ebeling & Assoc. makes no stops in ensuring its clients feel safe and compliant at all times with its targeted study design services that effectuate the development of better treatments. “We also report incidents to the responsible authorities using the current manufacturer incident report (MIR) template, and prepare periodic safety update reports (PSURs),” adds Dr. Ebeling.

To further elucidate on the competency of the company’s services, Dr. Ebeling shares the instance when a specific notified body expressed concerns about the preparation certification of Cetraria islandica as a medical device. The Notified Body, in its argument, cited the ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices’, where Cetraria islandica is considered a herbal medicinal substance and described to have pharmacological properties, including anti-inflammatory, antibacterial, and antiviral characteristics. To investigate the claim further, Dr. Ebeling and his team thoroughly analysed the data and compiled a statement, which summarised the current evidence and knowledge of the plant. The results from Dr. Ebeling & Assoc. led to the conclusion that the pharmacological properties of some constituents of Cetraria islandica, as reported in single publications, are not of relevance to its preparation for the intended purpose. “It could be demonstrated that the primary mode of action is achieved by the physicochemical properties of Cetraria islandica’s components contained in the used extract, thus justifying its classification as a medical device,” adds Dr. Ebeling. The notified body accepted the newly-drafted reports that were based on detailed scientific data, and has noted, that a deep analysis is mandatory to elucidate the appropriate solution.

Such instances shine a bright light on the competency of Dr. Ebeling & Assoc.’s services in the face of nationwide regulatory authorities, where they provide consistent factual reports on a medical device’s compliance. Moving forward, the company intends to continue capitalising on its decades of experience in the vigilance for medical devices. The company also excels in providing the appropriate marketing authorisation procedures for medicinal products throughout the EU. This can prove to be extremely helpful for the development of better functioning and compliant medical devices and products, ensuring the best healthcare delivery now, and in the future.