The regulations will not allow grandfathering of previously approved products, so device manufacturers will need to re-evaluate their entire product portfolio to identify the steps needed to ensure compliance. This impacts every aspect of the organization, from research and development to manufacturing and marketing.
Medical device manufacturers will likely need additional clinical data to certify and re-certify devices, which could be gathered or generated from various sources and methods. They will also need to perform additional post-market surveillance to provide safety and effectiveness oversight for the lifecycle of a device.
There are many understandable concerns about how this will impact device companies, and there are still many unknowns. In this resource, we’ll discuss the most important elements you need to know and how you can start preparing.
The history of clinical research includes numerous examples of device manufacturing that failed to protect patients.
Two examples in recent history illustrate this:
When the metal-on-metal devices rubbed against each other, they released toxic particles that caused serious side effects, including memory loss, the formation of necrotic tissue and allergic reactions.
These devices were found to cause significant harm to many patients, resulting in numerous lawsuits.
The Poly Implant Prothese (PIP) Breast Implant Scandal is another example of a large-scale failure to protect patients.
To save money, Jean-Claude Mas, a former butcher turned medical sales representative, began using breast implants from a cheaper, industrial-grade silicone that was not approved for medical use. These inferior implants ruptured at a rate that was double the industry average, causing inflammation, scarring and potential long-term side effects.
“The PIP scandal made it clear that immediate improvements in the oversight of medical devices were needed,” the European Commission stated in a 2014 news release. More ongoing clinical evidence and transparency may work to rebuild physician and patient trust in a system that is in place to safeguard consumers of medical devices.
“One of the key objectives of the new MDR is to ensure a consistently high level of health and safety protection for EU citizens using these products,” said Dr. Norbert Clemens in another European Commission news release.
The MDR replaces the Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD), the current regulations in place for medical devices in Europe. The new regulations have a wider scope, requiring data-based evidence for both new and existing medical devices.
Here are the key elements all medical device manufacturers need to know.
The new In vitro Diagnostic Regulation (IVDR) replaces the EU IVD Directive, which has been in place in Europe since 1998. This new regulation, intended to improve the health and safety of in vitro diagnostic devices, went into effect in April 2017. Device manufacturers must be fully compliant with this regulation by 2022.
The main elements are similar to the MDR, with a few added elements:
Where previously approximately 10% of IVDs required clinical data for approval, now an estimated 90% of devices will now be required to have supporting clinical data for approval under the IVDR.
With these deadlines looming, medical device manufacturers should take steps to prepare, starting with evaluating their product portfolio.
Manufacturers will need to conduct a cost/ROI analysis to determine what new data they will need. Here’s a helpful framework for moving forward:
Once you have determined you’ll need additional data to support your device, you’ll need to develop a plan for obtaining it.
Conducting a full-blown clinical trial is costly and time-consuming, but it may be necessary. You might also be able to use existing data from previous studies and sources.
The support you’ll need from a contract research organization (CRO) will depend on the study design you choose. You may need full-service study management or just one specific service, such as monitoring, auditing, training, consulting, safety oversight or remote data collection and data entry.
Other data collection design options include:
Enlisting a trusted contract research organization (CRO) will help you conduct compliant studies that protect human subjects, data integrity and your investment of resources. A CRO can also assist with post-marketing clinical follow-up (PMCF) plans.
Use creative approaches to plan strategic protocols, leverage real-world evidence (RWE), use electronic medical records for remote data collection and entry, and implement remote monitoring approaches to efficiently collect critical data.
There’s no way around it: complying with these new regulations is going to be painful. But the pain is lessened when you have a trusted advisor who will walk you through it.
As a global full-service medical device CRO, IMARC has 20 years of experience helping manufacturers achieve compliance. We can support your team through this transition in a number of ways, including: