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Clinical Data and CE Mark: What are We Doing Wrong?

The EU’s heightened focus on clinical data is causing issues for orthopaedic device companies, even ahead of the finalization and implementation of the Medical Device Regulation (MDR).

Last week, we received a call from a reader who said he’d spoken to colleagues at eight orthopaedic device companies, large and small. They’d failed the clinical evaluation portion of the initial CE Mark or audit process. What insights could we offer now, and will the topic be covered at OMTEC?

I sent an inquiry to Dr. Bassil Akra, Vice President - Global Focus Teams, Cardiovascular, Orthopedic and Clinical for TÜV SÜD, seeking his expertise.

In June 2016, a new clinical evaluation guidance document was published. (You can download it here.) Akra pointed out that the document outlines the way that companies should approach clinical evaluations—the process of collecting, appraising and analyzing clinical data—when substantial equivalency is needed, as well as how the expectations of the clinical evaluator were raised.

Akra said, “Medical device manufacturers are failing during the CE Approval Process either because they have devices on the market based on partial equivalency and didn´t do anything to collect their own clinical data over the lifetime of the device, or because they are overstressing the literature equivalence route.”

While the majority of the document focuses on planning, implementing and reporting clinical data, section 12 outlines the way that your Notified Body assesses and makes decisions about the data.

The ability to secure regulatory clearance is expected to toughen with the forthcoming MDR. We asked Akra to briefly explain what companies should expect.

He said, “With the new Medical Device Regulation, manufacturers of class III and implantable medical devices shall perform clinical investigations towards showing safety, performance and benefit risk profile of their devices. The equivalence approach is [only used] in the case of a device iteration or where the manufacturer of the comparable device provides full access to his technical documentation via a contractual agreement. This means that the equivalence approach will disappear for these types of devices in the coming future. For non-implantable and non-class III devices, the manufacturer has to show the level of access to the technical documentation of his competitor if he is planning to go through the equivalence approach. The new Medical Device Regulation does not include any rule for legacy devices, but requires any device to have sufficient clinical data allowing them to justify not doing new clinical investigations. In summary, a large number of devices will not be able to pass the new certification process when the new regulation is published and this is due to the missing clinical data supporting the claims of the manufacturer.

The overhauled regulation is expected to present problems for many companies, especially those focused on spine due to the up-classification of devices. While this article is outside of the scope of complete MDR changes, Yuan Li, RAC, Ph.D., Orthopedic Product Specialist/Auditor, TÜV SÜD will present a three-and-a-half hour workshop on the topic, including changes to stringent clinical evidence guidelines, at OMTEC 2017. Details on the Tuesday, June 13 workshop can be found here.