The European Commission has postponed the long-awaited — and perhaps dreaded — EU Medical Devices Regulation (MDR) date of application (DoA) from May 26, 2020, to May 26, 2021 with support from both industry and politicians. However, this delay does not push out all the dates affixed to the regulation.
The DoA delay actually reduces transition time from Medical Devices Directive (MDD) to MDR, from four to three years, as the final compliance date remains May 26, 2024. Thus, the delay gives companies some breathing space, but should not divert their attention away from MDR compliance. Rather, the delay provides manufacturers more opportunity to assess their readiness and close gaps.
This article discusses general MDR concerns medtechs should keep in mind as they adjust to the new timeline, as well as four critical MDR factors to address (or revisit) moving forward.
Indeed, critical elements that demand manufacturer focus remain mostly unchanged: dossiers and labeling of Class l devices that remain Class l under the MDR must be fully compliant (by the new 2021 DoA). All manufacturers must comply with requirements relating to economic operators (i.e. the supply chain), and they must have a robust postmarket surveillance system in place.
Note that the previous statement assumes MDD certificates covering all but Class l devices are extended beyond May 2021 to allow progressive updates of the technical documentation, and that the manufacturer in question has no immediate plans for new product launches. Notified Bodies (NBs) are warning manufacturers not to stop MDR conversion of their quality management systems (QMS) and the technical documentation, as the NBs don’t have the resources to manage new certifications in three (instead of four) years.
As of May 15, 2020, just 14 NBs have been designated under the MDR, the last coming in May.
US medtechs face the additional challenge of having a more complex supply chain compared to the EU manufacturers, who only have to deal with distributors. Thus, US medtechs need to secure an EU Authorized Representative in addition to finding one or more importers for their products. This increased complexity reinforces the need for full transparency on product flows into and within the EU, making clear the role of each economic operator and ensuring they meet MDR requirements.
More specifically, four key factors should be in medtechs’ crosshairs as they react to the MDR delay and plan for the future:
Additionally, consider that medtechs must have strategies in place for updating their QMS systems, as well as documented plans for the NB certification audits. Planning for product technical documentation and labelling updates needs to consider the validity dates of MDD certificates, time for assessment by the NB, and the time it will take to bring the products with updated labelling into the EU market.
The EUDAMED implementation postponement allows manufacturers more time to collect the data required for device registration, as well as implement a change control system for these data. The processes for collecting pre- and postmarket clinical data need to be reinforced to meet the new requirements.
The MDR continues to be the most significant and impactful legislative change to medtech in decades, and May 2021 will be here sooner than you think. The above requirements are just the beginning of the compliance journey.
Hilde Viroux is a medtech expert at PA Consulting
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