European Parliament adopts. Medical Device Regulation.

On 05 April 2017, the EU Parliament adopted the new Medical Devices Regulation. Associations and companies expect staff shortages and challenges for small and medium-sized enterprises.

Munich, 5 April 2017

On 05 April 2017, the European Parliament adopted the new European Medical Devices Regulation. Associations and companies expect staff shortages and special challenges for small and medium-sized enterprises.

After more than four years of negotiations, the European Parliament adopted the new European Medical Device Regulation (MDR) on 5 April 2017. The aim of the regulation is to increase the safety and quality of medical devices.
After the scandal about substandard medical devices of the French breast implant manufacturer Poly Implant Prothèse (PIP) in 2010, the European Commission had initiated the legislative process for the new MDR. Now that it has been adopted by the Parliament, the regulation can be published in the Official Journal of the EU. The MDR itself will enter into force 20 days after publication and will apply after a three-year transition period from mid-2020. However, this transition period is short in view of the extensive new requirements for manufacturers, notified bodies and other actors in the healthcare sector.
The MDR is intended to introduce a clear system for the traceability of medical devices in Europe. However, the implementation of the requirements by manufacturers presupposes the timely provision of a pan-European database (Eudamed). And this puts the European Commission under obligation. Because at the same time, the Europe-wide system of market monitoring by manufacturers and market surveillance by the authorities also depends on this database.
In addition, the regulation contains more detailed and comprehensive requirements for manufacturers in the evaluation of their products. With the resulting high costs for the companies, there is a danger that, for example, niche products will be withdrawn from the market because they are uneconomical and, as a result, will no longer be available to patients.
According to the German Medical Technology Association (BVMed), small and medium-sized companies in particular will face an additional burden. "Due to lower personnel capacities and financing options, small and medium-sized companies are also likely to be hit particularly hard by the comprehensive new clinical requirements as well as the extensive documentation and reporting obligations," BVMed said.
Entourage Task Force member Daniel Shoukier sees major challenges ahead for the medical technology industry. "At the moment we are experiencing major changes in Europe. While the FDA and other national regulatory authorities outside Europe are releasing new regulations and guidelines to facilitate market access especially for innovative medical devices, Europe is now marching in the opposite direction. It is wishful thinking to believe that the new and stricter regulations of the MDR will increase patient safety. In the future, patients in Europe will have to wait much longer to access new medical technologies. Many innovative medical devices that have been on the market safely and effectively outside Europe for many years will reach Europe with enormous delays or will not receive regulatory approval."
Dominik M. Aumer, founder and Managing Partner of Entourage, intends to meet the challenges of the new regulations with the unique service portfolio of the Munich and Basel-based management and HR consultancy: " We will support our clients in terms of content with our experienced task force consultants and at the same time help them with the necessary implementation steps in case of resource bottlenecks with operationally proven project consultants. With this unique combination of strategic competence and results-oriented implementation, we will jointly master the challenges of the new MDR."

Short profile Daniel Shoukier

Daniel Shoukier has been involved in medical device regulatory affairs and quality management systems worldwide as a consultant and lead auditor for more than 20 years.
A medical doctor and engineer, he works as a lead auditor and medical device reviewer for a notified body and supports companies as an FDA consultant in the approval of their medical devices in the USA. He is a lecturer at professional academies and in the internal further training of specialists in companies in the field of medical technology and is the author of specialist publications.
Through stations as lead auditor for TÜV Rheinland and management experience in regulatory affairs and quality at Olympus Medical in Germany, Biosensors in Switzerland and Novo Nordisk in Denmark, the regulatory expert has in-depth experience on the regulatory and corporate side.

Short profile Entourage

Entourage is a management and recruitment consultancy specialising in all natural science disciplines in the pharmaceutical and medical technology industries. With the placement of permanent employees and freelancers, as well as the supply of highly qualified natural scientists, the company, based in Munich, Zug and Basel, recruits experts for the leading life science companies in Germany, Austria and Switzerland. With the European Experts Network (EEN), Entourage taps into a Europe-wide potential of employees, freelancers and interim managers. With the Entourage Task Force (ETF), Entourage bundles selected interim managers into a high-calibre consulting unit that realises pharmaceutical and medical technology solution scenarios in an interdisciplinary manner in consulting projects.

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