With recent updates to ISO 10993-1 and the Medical Device Regulation (MDR) on track to replace Europe's current Medical Device Directive (MDD) next year, European medical device requirements present greater regulatory hurdles. The impending updates aim to minimize regional regulatory differences and establish a set of uniform compliance standards that uphold quality of care and ensure patient safety. With less than a year until the MDR takes effect (May 26, 2020) and a shrinking number of notified bodies, time is of the essence. Planning and partnership will help companies stay ahead of the curve, but one misstep could result in an avalanche of consequences, so organizations must be sure to dot their I's and cross their T's.
MDR will apply to devices being introduced to the market for the first time as well as legacy products. The MDD has historically allowed "grandfathering" devices or approving submissions with supplemental data from biocompatibility tests alone, but this will no longer be the case. OEMs will be required to have updated clinical data and technical documentation that supports the device's conformity with the new standards.
Although it will be a gradual transition and devices with a valid certificate will still be permitted on the market after May 2020, there will be strict deadlines regarding Quality System and Fbst Market Surveillance requirements when MDR takes effect.
Let's dive deeper into how medtech organizations can prepare for and navigate these changes.
Currently, OEMs are looking at MDR through many different lenses, some from a regulatory standpoint, others from a financial impact perspective, or worse, they haven't started planning. Of course, financial and business viewpoints are critical to consider when the survival of healthcare products is on the line, but if those are the only concerns or the internal teamwork model is siloed, companies may be missing the mark. Every stakeholder and department throughout the organization will feel the impact, which is why it is crucial to build a cross-functional team to tackle MDR.
To build such a team, companies should include internal people from quality, R&D, finance, product management, procurement, and other departments to gain a well-rounded understanding of how the new regulation affects their products. Together the cross-functional team can determine where gaps lie, how to prioritize products, and choose a testing laboratory or contract research organization (CRO) that meets the organization's needs.
Once assembled, the team can begin gathering existing information on devices to perform a gap analysis. The gap analysis evaluates current product portfolios against new regulatory...