EU Medical Device Regulation

KEY POINTS

• The new Europe (EU) Medical Device Regulations (MDR) published by the European Commission on May 5, 2017 revamps major portions of the EU Medical Devices Directives (MDD) and Active Implantable Medical Devices Directives (AIMDD).
• The regulation will apply starting May 2020 and specifically addresses the harmonization of notified bodies, an increase in transparency of the regulatory system, and the availability of clinical data to demonstrate safety and performance of medical devices in EU member states. Responsibilities for the Manufacturer, Importer, Authorized Representative and Distributors, also called the “economic operators,” are clearly outlined.
• Medtronic supports periodic review of, and updates to, medical device regulations to ensure that those regulations reflect best practices given the current state of the industry and advances in medical knowledge and technology.
• Medtronic supports the stated goal of the EU MDR: “To establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.” That goal is entirely consistent with the Medtronic Mission and with that of the other global regulators, including the U.S. Food and Drug Administration.
• Medtronic supports the EU Commission’s efforts to increase standardization in the medical device field—including the use of common specifications where appropriate—and to further enhance the already robust testing, safety and vigilance standards under the current Medical Devices Directives.
• Medtronic stands behind the safety and efficacy of all our medical devices and therapies. We will work closely with European regulators and Notified Bodies to ensure that we continue to meet and exceed the standards and goals embodied in the EU MDR.

Overview

1. Medical Device Regulation in Europe
   
   In May 2017, the EU MDR entered into force. The EU MDR replaces the MDD and AIMDD. While the Date of Application for the Regulation is May 2020, transition provisions allow manufacturers to place medical devices on the EU market with valid certificates issued according to the existing Medical Device Directives for a limited time beyond that date. However, certain EU MDR provisions become effective in May 2020, including post-market surveillance, market surveillance, vigilance, and registration of economic operators and devices.


2. Significant Changes in the EU MDR
   
   The EU MDR includes significant changes to the prior device regulation system in the EU. These include: (1) expansion of product scope; (2) implementation of unique device identification; (3) increased post-marketing oversight authority; (4) peer reviews and expert panel evaluation; (5) development of common specifications; (6) reclassification of devices according to risk, contact duration, and invasiveness; and (7) additional clinical evidence requirements for Class III and implantable devices, both pre- and post- approval. Of particular relevance, surgical mesh and spinal products will be classified as Class III devices.

See also:

• Medical Device Regulations and Pricing
• Continued Safety Monitoring and Adverse Event Reporting