European Medical Device Regulation (EU MDR)
The European Medical Device Regulation (EU MDR) will provide a robust regulatory framework for medical devices being manufactured in or supplied into Europe, while supporting innovation. In order to ensure a superior level of safety and efficacy, in line with the FDA’s UDI, the EU MDR is designed to improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed).
How does the EU MDR differ from the MDD?
Expanded definition of "medical device"
“Medical device’ definition will now have a broader scope, thereby including devices that may not have originally even had a medical purpose. Devices developed for the “prediction and prognosis” of diseases and health conditions, colored contact lenses, cosmetic devices are a few examples of the new inclusions.
More detailed tracking mechanisms
The use of unique device identification (UDI) mechanisms will enable device traceability from its manufacturer through to the final user. Manufacturers and authorities will be able to trace individual devices through their supply chain, enabling faster and more efficient recalls, if the devices have been deemed a safety risk. The establishment of a comprehensive EU database of medical devices (Eudamed) will result in improved transparency.
Enhanced examination by Notified Bodies (NBs)
Under the EU MDR, a large number of medical devices will require Notified Body review, resulting in some serious review and certification delays. Depending on the class of the device, manufacturers will also be required to submit annual safety and performance reports.
In order to strengthen the EU’s ability to enforce its regulations and reduce the risk of unsafe devices being on the market, Notified Bodies will now be able to perform unannounced audits, with product sample checks and product testing.
Greater emphasis on Post Market Surveillance (PMS)
The EU MDR has raised the bar on the need for clinical evidence and evaluation, which will result in stricter pre-market control of high-risk devices at an EU level. Increased requirements around compliance will result in more stringent PMS. From product design and development, to product and process changes, medical device companies are now expected to truly manage their products through the entire lifecycle and collect data about the real-life use of their devices. This may necessitate modification in CER processes and collection of additional data from clinical investigations, PMS activities and post-market clinical studies, such as post-market clinical follow-up (PMCF).
More stringent Technical Documentation
MDR will require manufacturers to update their technical documentation in accordance with the new risk classification system for diagnostic medical devices, based on international guidance. Class III and implantable devices will be subject to higher clinical requirements and increased scrutiny.
Provision of a "qualified person"
In accordance with the new rules, there must be at least one person within an organization that is ultimately responsible for all aspects of MDR compliance. The qualifications of this individual must be documented as they pertain to the required tasks.
No Exceptions
Under the MDR no “grandfathering” provisions are available for existing devices. All currently approved devices will need to undergo re-certification following the new requirements. While there are no current exceptions, a few exceptions are currently being negotiated which might apply in the future.
The implementation of the EU MDR will lead to heavier post-market surveillance requirements, among others, meaning more emphasis on risk management, post-market clinical evaluation, and ensuring conformity to new specifications through the device lifecycle. With this understanding, manufacturers can reduce time to market for new entrants, save valuable time & money by optimizing clinical evaluation processes, appropriate for that device, and reduce risks of recalls and lawsuits.
