What Does the Implementation of EU-MDR Mean?
The passing of the EU Medical Device Regulations (EU-MDR) is forcing medical device manufacturers to update their clinical testing practices and reporting mechanisms. The body of regulations that preceded the EU-MDR, the Medical Device Directive (MDD) is, in comparison, less than half the size of the EU-MDR, was passed in 1993, and is outdated to such an extent that it does not even contain formal contingencies for the definition and classification of software used in medical devices.
The EU-MDR, while it is a much-needed update to the MDD, is leaving many companies at risk of being barred from the EU market because their testing and reporting mechanisms are incompatible with the more stringent EU-MDR stipulations. The new law will be officially enforced on May 26, 2020. Some devices which are successfully certified prior to this date, in conformance with MDD, will have a maximum of five years to comply with EU-MDR. Device manufacturers must update their systems now if they are to continue to operate in the EU market.
Strengthened Post-Market Regulations
The EU's aging population, among other factors, is driving the legislative push to regulate the entire life-cycle of products under EU-MDR, unlike MDD which was principally concerned with device pre-approval and certification. This shift in emphasis is necessarily placing a greater burden on device manufacturers to improve the traceability of their products, reporting practices, and transparency with third-party auditors ("Notified Bodies").
Under EU-MDR, EU regulatory and enforcement bodies will be granted augmented post-market surveillance powers. Random audits and product sample checks will be permitted by the new regulations along with the mandatory provision of annual safety reports by device manufacturers.
An Expansion of Scope
Products previously exempt from regulatory oversight are now, under EU-MDR, officially defined, codified, and regulated. Under MDD, products without an unambiguous medically intended purpose such as cosmetic implant devices and colored contact lenses were exempt from special regulation, not so under EU-MDR. Furthermore, devices involved in the "prediction and prognosis" of health conditions are now formally subject to regulatory oversight.
New Specifications and Classifications
A new set of standards, the "Common Specifications," in concert with existing EU standards such as the State of the Art and the Harmonized Standards, is due to go into effect under EU-MDR. Devices will also be reclassified according to their contact duration and invasiveness. This reclassification will force device manufacturers to overhaul their technical documentation in order to conform with new reporting requirements. This means Class IIa and Class IIb devices must be reevaluated and, in the case of Class III and implantable devices, possibly undergo further clinical investigation due to expanded data collection and safety requirements.
How Should Companies Prepare?
Businesses should be proactive in the face of these oncoming regulations. In the months preceding the official enforcement of EU-MDR, in addition to the five years of amnesty that recently certified devices under MDD are due to receive, must be utilized to overhaul existing systems and bring them in compliance with EU-MDR standards. Companies must conduct a full review of their product portfolios and ensure that policies such as post-market surveillance, safety reporting, technical documentation, and clinical data gathering are sufficiently up-to-date across their product lines.
EU-MDR is forcing many companies to update their legacy systems and utilize modern, streamlined, and transparent processes in their day-to-day operations. Nonetheless, it is true that many medical device companies are unprepared for EU-MDR; they are unprepared for the rigorous post-market surveillance, the expanded regulatory oversight, and new specifications that will necessitate an expensive revision of their technical documentation. As long as medical device manufacturers and distributors take a proactive approach to this new wave of regulations, they can weather this storm.