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The new regulation on medical devices means a huge challenge for manufacturers.

The legislative procedure has taken more than four years until the ruling on the new regulation on medical devices (MDR) – which is directly applicable in every member state – as well as a specific regulation for in-vitro-diagnostics have been issued. The new directive on medical devices (VO (EU) 2017/745) came into effect on May 26, 2017. It will become applicable in three years, on May 26, 2020. Now manufacturers of medical devices should already inform themselves of the new legislation and prepare for upcoming changes. The MDR is transforming almost all fields of medical devices law.

A significant change is strengthening rules regarding the classification of products. This especially affects devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body subject to conformity assessment procedures according to the new legislation as soon as it comes into effect, it is already foreseeable, that this will lead to an overload of the notified bodies. Therefore, manufacturers should contact the notified body without delay to ensure the marketability of their own product. The classifications of products containing nano-particles or products with pharmaceutical contents are now subject to the amended regulations.

In addition the MDR comprises numerous other amendments. For the first time, regulations for the duties of distributors and importers are defined. Products without medicinal purpose which are listed on a positive list are now subject to regulations of medicinal products.

Requirements related to vigilance, clinical investigation and clinical evaluation are reformulated. Furthermore, it becomes necessary, to have a person responsible to ensure regulatory compliance in employment or as a contact person. Their responsibility would not only include vigilance as applies in Germany for example for security managers but also the assurance of conformity of the products as well as the creation and up-dating of technical documentation. In the long-term a comprehen-sive traceability system for medical devices is envisaged. Also, the regulations on labeling of medical devices have been amended.

The MDR contains numerous transitional provisions, which apply especially to medical devices classified in higher risk groups as well as general regulations regarding the sale of medical devices for a period of up to five years, which have been marketed according to previous law.

If you have questions regarding these complex amendments please feel free to contact us at any time.

Christian Karle


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