Part 5 in a 7-part series on the EU’s Medical Device Regulation
Among the significant changes facing device makers transitioning their products in the European Union from the Medical Device Directives (MDD) to the Medical Device Regulation (MDR) are the new requirements around clinical evidence.
Under the MDR, device manufacturers marketing products in the EU will face some additional hurdles, but if you also market in the US, Canada, Japan, or other countries, the new regulations will likely be familiar to you.
The big shift in the EU’s MDR is toward a much greater emphasis on ensuring a high level of health and safety protections for EU citizens.
To that end, the new clinical evidence requirements under section 61 of the MDR move away from reliance on device equivalence, particularly for higher risk devices, and to a much stricter scrutiny that relies much more on demonstration of safety and performance based on clinical data and scientific validity.
What does clinical data mean and what are acceptable sources?
While clinical evidence requirements are not new, the MDR sets out stricter requirements in terms of both clinical data and comparative evaluations.
The MDR defines clinical data as safety and performance information generated from the use of the device. The accepted sources of that data include:
- Investigation of a particular device or other studies reported in scientific literature, or
- Clinical investigations or other studies reported in scientific literature of a similar device with demonstrated equivalence, or
- Published or unpublished reports on clinical experience of either a particular device or a similar device with demonstrated equivalence.
While equivalence data is acceptable, it is important to note that under Article 44, Notified Bodies are required to submit new technical review reports demonstrating equivalence. That means manufacturers and their representatives need to produce a greater volume of data along with more rigorous scientific evaluation of that data. Perhaps most troubling is the requirement for demonstrating equivalence that includes gaining access to a competitor’s technical files for CERs, according to the Orthopedic Design and Technology Forum.
What is the impact on existing studies being executed under MDD?
In an article for Med Device Online, Tido Eger, PhD, an expert in healthcare and life sciences regulatory compliance, says Clinical Evidence Reports (CERs) under MDD need to be reassessed based on the limitations on equivalent devices and the higher level of evidence demonstrating equivalence that is likely to be required by the Notified Body under Article 32. Clinical investigations will need to be re-evaluated to ensure they were conducted using the scientific standards required under the MDR.
“Existing studies should consider which additional MDR burdens are worth implementing now, so the data can be used in future submissions,” Eger wrote. “New studies should be set up with the MDR in mind, as clinical evaluation will become a continuous process.”
In addition, summaries of safety and clinical performance under MDR will need to be updated at least annually for innovative or high-risk devices and every two to five years for well-established lower-risk devices. Notified Bodies will be looking for ongoing collection of post-market clinical evidence as new clinical data becomes available or changes are made to product design or intended use.
Will new clinical evidence be required for existing products?
While some requirements under the MDD carry over into the MDR, makers can assume the clinical support for a device will require re-evaluation at some point. According to Healthcare-in-Europe.com one of the more troubling hurdles for medical device makers is the potential need for clinical data for older devices that have proved their value already.
Under the MDR, Class III and implantable devices are expected to have data from clinical investigations that were conducted under the supervision of a sponsor using Good Clinical Practices as outlined in ISO 14155:2011.
In addition, reclassification of devices under the MDR will require costly certification processes for new products as well as re-certification of products already on the market resulting from the shift away from approval, to focusing on the product’s entire life cycle, which will require greater ongoing clinical evaluation.
If you are looking for help with how MDR affects your organization, Kapstone Medical has the experience and expertise to assess your product portfolio, quality management system procedures, and design history files. Contact us for more information.