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.
Entourage's Principal Project Consultant, Dr. Ralf Hess and 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, RAPS for short.
This article discusses current revisions of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) in the European Union (EU). Based on the implementation activities in German legislation, the authors examine revisions from an implementation perspective. The impact of this new regulatory environment and the associated challenges for MDR/IVDR manufacturers are highlighted and hurdles and "bottlenecks" that may make full implementation by May 26, 2020 (MDR) difficult are discussed.
Under this link, members of RAPS can find the article: Article on RAPS.org
Interested readers have the opportunity to obtain an offprint of the article.
Testimonials.
Dr. Ralf Hess Statement summarizes what readers can expect from the article.
"Medical device manufacturers in Europe must perform at the highest level with the conversion and introduction of the amended IVDR and MDR in order to bring legally compliant medical devices onto the market after the date of application of the regulations. Now that the currently valid medical device directives have been implemented in regulations that represent the latest state of science and technology, but also lessons learned from the old, outdated directives, not only the manufacturers but also the legislators and notified bodies are required to a high degree to realize these implementations within the legally prescribed transition period.
There is no doubt that the new, much stricter legal requirements serve to improve patient safety and the assured effectiveness of medical devices, but the bureaucratic and administrative effort required - within a relatively short period of time - is so high that it is to be feared that medical devices and, in particular, the involvement of notified bodies, which is very often required for CE marking, will represent a "bottleneck" that could lead to bottlenecks in the availability of these newly assessed medical devices and ultimately the patient could be the one to suffer. In regulatory terms, we are taking a step in the direction of the approval of medicinal products."
Dominik M. Aumer, Managing Partner and founder of Entourage, on the publication.
"MDR and IVDR pose major challenges for our clients. 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 level of operational implementation is Entourage's unique selling point. We look forward to exciting projects - from the technical concept to successful implementation."
Short profile Dr Ralf Hess.
Dr Ralf Hess studied biology at the Albert-Ludwigs-University of Freiburg and received his doctorate at the Institute of Virology. Dr. Hess has many years of experience in the development of medical devices and medicinal products as well as their combination, in laboratory analytics and their quality assurance. The quality expert has established, implemented and maintained QM systems according to ISO and GxP for various application areas. The customer service portfolio ranges from manufacturers of classical and biological drugs, medical device companies and vaccine manufacturers to immunohistochemical, immunological, molecular biological and serological diagnostic laboratories. Dr. Hess is active worldwide as an auditor in the GxP/ISO area and has many years of experience in FDA remediation projects and the regulatory development of combination products (drug device products).
Dr. Ralf Hess supports Entourage as Principal Project Consultant.
Short profile RAPS.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organisation of and for those involved in the regulation of health and allied products, including medical devices, pharmaceuticals, biologics and food. Founded in 1976, RAPS helped build the regulatory profession and continues to actively support experts and guide the profession as a neutral, non-profit, non-lobbying organisation. 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 recognises regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices and affiliates worldwide.
Translated from English by: https://www.raps.org/who-we-are
Short Profile Entourage.
Entourage is a management and HR consultancy with a focus on pharmaceuticals, medical technology and health care. With the placement of permanent scientific employees and consultants, the Munich and Basel-based company wins experts for the leading life science companies in the DACH region. With Project Consultants, Entourage realises projects for its clients through highly qualified temporary staffing and contracts for work. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a high-calibre consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
