Regulation (EU) 2017/745 on Medical Devices
This regulation applies from 26 May 2020 and marks the beginning of a new era in the medical device industry. More detailed information on the entry into force and date of application can be found in Article 123 of the new Medical Device Regulation.
The validity date for all manufacturers of risk class I products, which are the first required to demonstrate compliance with the new regulation, is May 25, 2020. (The transitional provisions of Article 120 do not apply to these products.)
Increased Requirements and Many Uncertainties
In addition to the increased requirements placed on notified bodies, the requirements for manufacturers and economic operators have also significantly increased. Additionally, many questions may remain unclear about new or adapted requirements, which can be critical for your company and product portfolio through the adoption of implementing acts, delegated acts and common specifications.
The new or more specific requirements of the Medical Devices Regulation include the labeling of medical devices, along with the requirements for UDI and the European database EUDAMED, requirements for technical documentation, quality and risk management, classification and conformity assessment, and the strengthened requirements for clinical evaluations and clinical investigations. In addition, the consideration and analysis of information on the safety and performance of products from the market phase plays a crucial role in the post-market surveillance requirements.
New requirements are also placed on the role of economic operators, which must be implemented by the manufacturers as well as by the economic operators themselves.
Take Advantage of Our Experience
The multitude of changes poses new challenges to medical device manufacturers, economic operators and notified bodies. As a manufacturer and business player, you can leverage our extensive knowledge to steer your business to regulatory compliance within the deadlines set.
We have already successfully completed implementation projects and developed helpful strategies and solutions that we can use to successfully support you in implementing the new and changed requirements. For more details on the Medical Device Regulation or for a non-binding offer, please contact us.
To ensure that you and your employees can implement the new and changed requirements in time, you can book one of our open courses or a customized training course for your company. Based on practical examples and suggested solutions, we show you how the requirements of the MDR can be transferred to successful planning for implementation.
Use our experience and network so that the regulation does not become a surprise for you and your company.
Find out all about the Regulation (EU) 2017/745 on medical devices and the Regulation (EU) on in vitro diagnostics 2017/746. Take advantage of one of our numerous education seminars and prepare yourself for the new regulatory and normative requirements. For questions or for a non-binding offer, please contact us.