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The highly-anticipated draft of the European Union’s Medical Device Regulations (MDR), released on June 15, means that orthopaedic device manufacturers can begin to fully prepare for what will ultimately be a more scrutinized process to develop and sell products in EU countries.
The 400-some pages of regulations are broken into ten chapters and 17 annexes, but come with no published guidance documents for implementation. The first reaction from industry experts has been that it will take time for device manufacturers, regulatory consultants and Notified Bodies to truly identify all of the troublesome areas of compliance.
It’s important to note, though, that total and partial joint replacement devices and spinal disc replacement implants and implantable devices—other than screws, plates and instruments—are considered to be Class III and will undergo greater examination than other medical devices. Additionally, the MDR places increased responsibilities on and imposes greater scrutiny of Notified Bodies, which have decreased in number and are expected to continue to do so as organizations are not re-designated under new requirements. Orthopaedic device manufacturers that haven’t begun to consider how the new regulations will impact their business in Europe should begin immediately. Notified Bodies will be more involved in your timeline to market and your ability to stay on the market—and remember, there will be fewer of them with more responsibilities.
As you comb through the regulations, consider that these changes will be important for orthopaedic device companies to navigate.
Clinical Evidence
In recent years, orthopaedic device companies with novel technologies have turned to Europe first to conduct clinical investigations and seek device approval before moving to the U.S. However, changes to the clinical evidence requirements could cause concern about delays to market, obstruction of future innovation and give one pause about entering European markets first.
For Class III devices, clinical investigations will need to be performed except if the device is a modified design of a device already marketed by the same manufacturer, or the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device.
Not only are stricter rules expected in proving equivalency to other products and conducting clinical investigations, but device manufacturers will also need to establish, implement and maintain a postmarket surveillance system for devices.
Labeling
The addition of Unique Device Identification (UDI) to all medical devices should not come as a surprise to those who have followed the MDR’s evolution. A priority of the EU has been to launch a UDI system comparable to international initiatives.
While multiple labeling changes will need to be considered, here are two points in the final document:
- The UDI should be placed on the label or the device itself.
- Devices that are reusable should bear a UDI on the device itself. Exceptions are made if the direct marking would interfere with the safety or performance of the device or if it’s not technologically feasible for the device to be directly marked.
Supply Chain
As previously reported, liability issues have increased throughout the supply chain. Importers and distributors will no longer be subject to fragmented national law obligations and instead will need to comply with MDR mandates. The main requirement is that parties will need to verify that their partners are in compliance with the MDR.
Device companies not established in the EU will need to designate an authorized representative who will be held jointly liable for things like medical device defects. This could prompt companies to scrutinize non-EU based manufacturers more carefully, and will most likely increase their monitoring of clients’ compliance.
The regulations are expected to go into effect in late 2019 or early 2020. They are expected to be translated for all EU member languages in late 2016 or early 2017, and then formally published. A three-year transition period will follow.
