Dr. Ralf Hess et al., publish. Article on the implementation of MDR & IVDR into national law.

Dr. Ralf Hess et al., publish. Article on the implementation of MDR & IVDR into national law.

Munich, 18 September 2019.

Entourage Principal Project Consultant Dr. Ralf Hess publishes article on the implementation of MDR & IVDR into national law. In Regulatory Focus. September 2019: Regulatory Affairs Professionals Society. 2.

The Principal Project Consultant of Entourage, Dr. Ralf Hess, Dominik M Aumer and Dr. Simon Schulz publish an article entitled “Implementation of IVDR and MDR Into National Legislation: a mission impossible?” in the online magazine of the Regulatory Affairs Professionals Society, short: RAPS.
This article discusses current revisions of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) in the European Union (EU). On the basis of the implementation activities into German legislation, the authors examine revisions from the implementation perspective. The effects of this new regulatory environment and the associated challenges for MDR/IVDR manufacturers are highlighted and hurdles and “bottlenecks” are discussed that could make full implementation difficult by 26 May 2020 (MDR).

Under this link members of the RAPS can find the article:
Find the Article on RAPS.org

For interested readers there is the possibility to receive a special reprint of the article.
With permission of RAPS and with recommendations of Ralf Hess

Order now.


Dr. Ralf Hess Statement outlines what readers can expect from the article.
“Medical device manufacturers in Europe have to deliver top performance with the changeover and introduction of the amended IVDR and MDR in order to bring compliant medical devices to the market after the prescriptions’ applicability date. After the currently still valid medical device guidelines have been implemented in regulations representing the latest state of science and technology, but also lessons learned from the old, outdated guidelines, not only the manufacturers but also the legislators and notified bodies are required to implement these implementations to a high degree within the legally prescribed transition period.
There is no doubt that the new, much higher legal requirements serve patient safety and the more secure effectiveness of medical devices, but the bureaucratic and administrative effort – which has to be carried out within a relatively short period of time – is so high that it must be feared that medical devices, and in particular the participation of Notified Bodies very frequently required for CE marking, represent a “bottleneck” which can lead to bottlenecks in the availability of these reassessed medical devices and ultimately the patient could be the victim. Regulatory, we are taking a step in the direction of drug approval.”

Dominik M. Aumer, Managing Partner and founder of Entourage, on the publication.
“MDR and IVDR present our clients with major challenges. With this publication, Entourage underlines its high level of expertise in strategically supporting companies in overcoming these challenges. The combination of strategic expertise and our high degree of operational implementation is the unique selling point of Entourage. We are looking forward to exciting projects – from the technical concept to the successful implementation.”

Short Profile Dr. Ralf Hess.

Dr. Ralf Hess studierte Biologie an der Albert-Ludwigs-Universität Freiburg und promovierte ebenda am Institut für Virologie. Dr. Hess verfügt über langjährige Erfahrung in der Entwicklung von Medizinprodukten und Arzneimitteln sowie deren Kombination, in der Laboranalytik und deren Qualitätssicherung. Der Qualitäts-Experte hat QM-Systeme nach ISO und GxP für verschiedene Anwendungsbereiche aufgebaut, implementiert und aufrechterhalten. Das Kundendienstleistungsportfolio reicht von Herstellern klassischer und biologischer Medikamente über Medizinprodukteunternehmen und Impfstoffherstellern bis hin zu immunhistochemischen, immunologischen, molekularbiologischen und serologisch-diagnostischen Laboren. Dr. Hess ist weltweit als Auditor im GxP/ISO-Bereich tätig und hat langjährige Erfahrung in FDA Remediation Projekten sowie der regulatorischen Entwicklung von Kombinationsprodukten (Drug Device Products).

Short Profile RAPS.

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved in the regulation of health and related products, including medical devices, pharmaceuticals, biologics and food. Founded in 1976, RAPS helped build the regulatory profession and continues to actively support the experts and lead the profession as a neutral, nonprofit, lobby-free organization. RAPS provides education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional qualification that recognizes regulatory excellence. RAPS is headquartered in Washington, DC with offices and subsidiaries worldwide.

Taken from: https://www.raps.org/who-we-are

Short Profile Entourage.

Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.